This page shows what was measured, who it was measured in, and what that does not settle.
What Ciclosporin does in the body
Cyclosporine first binds a small protein inside the cell called cyclophilin, and the two of them together block that enzyme.
When an immune cell recognises a transplanted organ as foreign, a calcium signal switches on an enzyme that releases the cell’s call for reinforcements. The call is never made, and the attack never assembles. It reaches the same enzyme by a different route than tacrolimus does, through a different partner protein, which is why the two drugs share a mechanism and differ in their side effects. The same enzyme regulates blood vessel tone in the kidney, which is where the drug’s main harm comes from.
Why people take it. Preventing rejection of a transplanted organ, severe rheumatoid arthritis and psoriasis, and chronic dry eye
What happened in people
Serum creatinine 2.6 against 2.0 mg/dL at 90 days in the same trial, P=0.03
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That inhibiting the mitochondrial permeability transition pore limits human reperfusion injury — supported by biomarkers in 58 patients, refuted on outcomes in 970
Where it acts
The cytoplasm of T lymphocytes. For the ophthalmic emulsion, the conjunctiva and lacrimal gland surface, where the intended effect is local and systemic blood levels are below the limit of quantification.
Kind of result
A number that stands in for health
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 83HN0GTJ6D · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 139 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Healthy ageing
…Waiting for a reviewer4 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Recovery
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
who experienced transplant related mortality; non relapse mortality; transplant related mortality; transplant related mortality 100 days post transplant
Recovery
hematopoietic recovery
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
… Waiting for a reviewer
4 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Results from the one trial this record names
In NCT04523129, Change from baseline in total corneal fluorescein staining, graded on the National Eye Institute scale from 0 (best) to 15 (worst): co-primary endpoint was CyclASol (cyclosporine ophthalmic solution) arm, 409 participants: least-squares mean change of -3.96 (standard error 0.146) against Vehicle arm, 395 participants: least-squares mean change of -3.55 (standard error 0.149) in the comparison group at Baseline and 1 month (day 29).
ClinicalTrials.gov record · NCT04523129 · read 2026-08-28
In NCT04523129, Change from baseline in eye dryness score, rated on a visual analogue scale from 0 to 100: co-primary endpoint was CyclASol (cyclosporine ophthalmic solution) arm, 409 participants: least-squares mean change of -12.2 (standard error 1.29) against Vehicle arm, 395 participants: least-squares mean change of -13.6 (standard error 1.31) in the comparison group at Baseline and 1 month (day 29).
ClinicalTrials.gov record · NCT04523129 · read 2026-08-28
Graft survival at one year after cadaveric renal transplantation
✓ The study showed what it set out to show
Who was studied
Canadian Multicentre Transplant Study (1983)
How many people
209
Study design
Randomised, multicentre, active-controlled
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Predicted one-year graft survival 80.4% against 64.0%, P=0.003; predicted patient survival 96.6% against 86.4%
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Serum creatinine at 90 days was worse on cyclosporine (2.6 against 2.0 mg/dL, P=0.03), and graft survival on cyclosporine was substantially worse where cold ischaemia exceeded 24 hours (70% against 88%, P=0.005). The nephrotoxicity was in the founding trial, not discovered later.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Both cyclosporine arms fell in the 56.7 to 59.4 mL/min band against 65.4 for low-dose tacrolimus; acute rejection 24.0% and 25.8% against 12.3%; allograft survival 93.1% and 89.3% against 94.2%, P=0.02 across arms
Repeated elsewhere
Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The standard-dose cyclosporine arm alone received no induction agent, which confounds that comparison. The low-dose cyclosporine arm did receive daclizumab and still trailed tacrolimus on all three endpoints.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Composite of death, worsening heart failure during initial hospitalisation, rehospitalisation for heart failure, or adverse left ventricular remodelling at 1 year
59.0% against 58.1%; odds ratio 1.04 (95% CI 0.78 to 1.39), P=0.77
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No separate component of the composite moved, including recurrent infarction, unstable angina and stroke. The 58-patient pilot that motivated this trial had reported significant reductions in creatine kinase release and MRI infarct mass, on endpoints that are not clinical outcomes.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Clinical response permitting hospital discharge on oral medication, in steroid-refractory severe ulcerative colitis
✓ The study showed what it set out to show
Who was studied
Lichtiger 1994 severe ulcerative colitis trial
How many people
20
Study design
Randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
9 of 11 (82%) against 0 of 9, P<0.001, within a mean of seven days
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Twenty patients in total. The trial could not run longer or larger because non-response meant colectomy, and five placebo non-responders were crossed over to open cyclosporine. It is a genuine result on a denominator too small to estimate an effect size from.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Objective signs of dry eye — corneal and interpalpebral dye staining and Schirmer tear test — and subjective symptom measures
✓ The study showed what it set out to show
Who was studied
CsA Phase 3 dry eye programme (Sall 2000)
How many people
877
Study design
Two identical randomised, double-masked, vehicle-controlled 6-month trials
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Significantly greater improvement than vehicle in corneal staining and categorised Schirmer values at P at or below 0.05 for both 0.05% and 0.1%; no dose-response between the two strengths
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Only three of the reported subjective measures separated from vehicle for the 0.05% strength, and the absence of any dose-response between a strength and double that strength is a finding that argues against a straightforward pharmacological effect.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.15 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Dog, Non-human primate. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Where a source records it acting
Eyes: A calcineurin inhibitor immunosuppressant applied to the eye, recorded for the signs and symptoms of dry eye disease
US prescribing information · 0a60fccf-7e1b-44fe-e063-6394a90aadd5 · read 2026-08-28
Start
Ciclosporin
What a person takes: Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions.
The measurement behind this step
Oral absorption of the original oil formulation depends on bile and is highly variable; the microemulsion preconcentrate was developed to remove that dependence and gives higher and more consistent exposure. The two are not bioequivalent and the label forbids interchange without supervision and level monitoring. Clearance is by CYP3A4 with P-glycoprotein efflux, giving an extensive interaction list. The ophthalmic emulsion is designed to keep a lipophilic molecule on the ocular surface; blood concentrations after topical use are below the limit of quantification.
Getting in
A ring of eleven amino acids, made by a mould
Cyclosporine is a closed loop of eleven building blocks, produced by a fungus found in Norwegian soil in 1970. Its shape is what lets it slip through cell membranes despite being enormous by drug standards.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
A cyclic undecapeptide of 1,202.6 g/mol with seven N-methylated amide bonds and the non-proteinogenic residue MeBmt at position 1. The N-methylation removes hydrogen-bond donors and lets the molecule adopt a closed, internally hydrogen-bonded conformation in lipid environments — the reason a 1.2-kilodalton peptide is orally absorbed at all.
The original capsules needed bile to be absorbed properly, which made blood levels unpredictable. A later formulation pre-mixes the drug into microscopic droplets so it does not depend on the gut’s own emulsifying.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
The Sandimmune oil formulation requires biliary emulsification and shows wide inter- and intra-patient variability, especially in liver transplant recipients. The Neoral self-microemulsifying preconcentrate forms a fine dispersion on contact with aqueous fluid and gives higher, more reproducible exposure. The two are not bioequivalent.
The drug pairs up with an abundant small protein in the cell. Neither one alone blocks anything; the pair is the working unit.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Binds cyclophilin A, a peptidyl-prolyl cis-trans isomerase. The composite surface of the cyclosporine-cyclophilin complex is what recognises calcineurin — structurally distinct from, but functionally parallel to, the tacrolimus-FKBP12 complex.
The complex blocks calcineurin and interleukin-2 is never transcribed
That pair sits on the enzyme that would otherwise unlock the transcription factor for the immune system’s main recruitment signal. Blocked, the signal is never made and the response never assembles.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The complex binds at the calcineurin A and B subunit interface and blocks substrate access. Nuclear factor of activated T cells stays phosphorylated and cytoplasmic, so IL2, IL4, IFNG and CD40LG transcription is not initiated. Cyclophilin binding also underlies a second, unrelated action: inhibition of the mitochondrial permeability transition pore through cyclophilin D, which was the rationale for the heart-attack trials.
Rejection rates fall, and transplantation becomes routine
The first randomised trial raised one-year kidney survival from about two-thirds to about four-fifths. Every solid organ transplant programme in the world dates from that result.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Predicted one-year graft survival 80.4% against 64.0% on azathioprine and prednisone (P=0.003) in 209 randomised cadaveric kidney recipients, with predicted patient survival 96.6% against 86.4%.
The same enzyme controls the tone of the small artery feeding each filtering unit of the kidney. Blocking it narrows that artery, which is why the drug that saves the transplanted kidney also damages it.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Afferent arteriolar vasoconstriction with reduced renal blood flow and glomerular filtration, reversible acutely and associated on chronic exposure with arteriolar hyalinosis and striped interstitial fibrosis. The first trial already measured it — creatinine 2.6 against 2.0 mg/dL at 90 days — and showed it interacting with pre-existing ischaemic injury. Hypertension, gingival hyperplasia and hypertrichosis complete the characteristic profile.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
event free survival
relapse rate for lymphoma after autologous transplant
who experienced transplant related mortality
non relapse mortality
transplant related mortality
disease free survival
duration of remission
overall survival
progression free survival
relapse free survival
and 5 more.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (25)
maximum tolerated dose
time to neutrophil engraftment
overall response rate
rates of durable engraftment in
safety and efficacy of sirolimus
partial or complete response
incidence of primary graft failure
immune response
adverse events
incidence of chronic gvhd
graft function measurnment
disease response
hematopoietic recovery
incidence of graft versus host disease
feasibility in terms of accrual
hematologic parameters
engraftment
toxicity
complete response rate
renal function
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Transplant recipients, though far fewer than in the 1990s; people with severe psoriasis or rheumatoid arthritis; people with severe steroid-refractory ulcerative colitis; and, in a completely different formulation and at a completely different scale, millions of people with chronic dry eye.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
Who a named study recorded including and excluding
NCT04523129 recorded its participants as: Adults 18 years and older, all sexes; not healthy volunteers.
ClinicalTrials.gov record · NCT04523129 · read 2026-08-28
It included: Signed ICF (Informed Consent Form); Patient-reported history of DED in both eyes; Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms; Ability and willingness to follow instructions, including participation in all study assessments and visits.
ClinicalTrials.gov record · NCT04523129 · read 2026-08-28
It excluded: Women who are pregnant, nursing or planning a pregnancy; Clinically significant slit-lamp findings or abnormal lid anatomy at screening; Ocular/periocular malignancy; History of herpetic keratitis; Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study; Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening.
ClinicalTrials.gov record · NCT04523129 · read 2026-08-28
What the label states about particular groups
On pediatric, the label states: “Safety and efficacy have not been established in pediatric patients below the age of 16.”
US prescribing information · ff4dc2fc-667a-489a-b798-8d11cddfe716 · read 2026-08-30
On older people, the label states: “No overall difference in safety or effectiveness has been observed between elderly and younger patients.”
US prescribing information · ff4dc2fc-667a-489a-b798-8d11cddfe716 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Clinical administration of cyclosporine ophthalmic emulsion, 0.05% is not detected systemically following topical ocular administration [ see Clinical Pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug.”
US prescribing information · ff4dc2fc-667a-489a-b798-8d11cddfe716 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated.”
US prescribing information · ff4dc2fc-667a-489a-b798-8d11cddfe716 · read 2026-08-30
Where the result stopped carrying
CIRCUS found no effect on any component of its composite outcome in 970 patients after a promising 58-patient pilot
ELITE-Symphony placed both cyclosporine arms behind low-dose tacrolimus on kidney function, rejection and graft survival
The nephrotoxicity that defines the class was measurable in the founding 1983 trial, and interacted with prolonged cold ischaemia to cut graft survival to 70% against 88%
The Saint Regis Mohawk assignment was held ineffective by the Federal Circuit, and the patents were separately invalidated
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S6.
No source is stored against this line.
What is in the pack
Oral absorption of the original oil formulation depends on bile and is highly variable; the microemulsion preconcentrate was developed to remove that dependence and gives higher and more consistent exposure. The two are not bioequivalent and the label forbids interchange without supervision and level monitoring. Clearance is by CYP3A4 with P-glycoprotein efflux, giving an extensive interaction list. The ophthalmic emulsion is designed to keep a lipophilic molecule on the ocular surface; blood concentrations after topical use are below the limit of quantification.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Boxed warnings covering administration only by physicians experienced in immunosuppressive therapy, increased susceptibility to infection and lymphoma, hypertension and nephrotoxicity — the last of which was measurable in the founding trial — and, for the psoriasis indication, an additional warning about malignancy in patients previously treated with PUVA and other immunosuppressants. Characteristic and largely cyclosporine-specific effects include gingival hyperplasia, hypertrichosis and tremor. Hyperkalaemia, hypomagnesaemia, hyperuricaemia and gout, hyperlipidaemia and posterior reversible encephalopathy syndrome are all labelled. The ophthalmic emulsion’s commonest adverse effect is ocular burning on instillation.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Ciclosporin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 18699 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oil-based soft gelatin capsules and oral solution (Sandimmune), self-microemulsifying capsules and oral solution (Neoral, Gengraf), intravenous concentrate, and 0.05% and 0.09% ophthalmic emulsions and solutions
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
The two are not bioequivalent and the label forbids interchange without supervision and level monitoring. Clearance is by CYP3A4 with P-glycoprotein efflux, giving an extensive interaction list. The ophthalmic emulsion is designed to keep a lipophilic molecule on the ocular surface; blood concentrations after topical use are below the limit of quantification.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
74 products list this as an active ingredient in the United States drug directory. 74 of them contain it and nothing else.
FDA National Drug Code directory · 11014-0040 · read 2026-08-29
They are sold as capsule, capsule, gelatin coated, capsule, liquid filled, emulsion, injection and powder, taken intravenous, ophthalmic, oral and topical.
FDA National Drug Code directory · 11014-0040 · read 2026-08-29
The regulator's established pharmacologic class for it is calcineurin inhibitor immunosuppressant [epc], calcineurin inhibitors [moa] and cytochrome p450 3a4 inhibitors [moa].
FDA National Drug Code directory · 11014-0040 · read 2026-08-29
25 published labels name it as an active ingredient. 25 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · c795cd2f-89da-78e3-e053-2a95a90a9422 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · c795cd2f-89da-78e3-e053-2a95a90a9422 · read 2026-08-29
26 marketed supplement labels list this ingredient, classed as botanical with nutrients and other combinations.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Vevye is clear, colorless non-preserved ophthalmic solution in a multiple-dose bottle at Cyclosporine 0.1% (1 mg/mL), delivering 0.01 mg of cyclosporine per one drop (0.01 mL), recorded as prescription product; fda label in effect 2026-02-26 in the United States.
US prescribing information · 0a60fccf-7e1b-44fe-e063-6394a90aadd5 · read 2026-08-28
Recorded price in US: 0.92396–7.29144 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 22 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Ciclosporin studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That inhibiting the mitochondrial permeability transition pore limits human reperfusion injury — supported by biomarkers in 58 patients, refuted on outcomes in 970
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That improvement in corneal staining and Schirmer score amounts to the improvement in dry eye a patient would report; most symptom endpoints did not separate and there was no dose-response
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That "cyclosporine" names a single exposure profile, when the oil-based and microemulsion formulations are explicitly not interchangeable
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the patent term on the ophthalmic emulsion reflected development cost, given the 2017 assignment to a sovereign tribe for the stated purpose of blocking validity review
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Ciclosporin are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
The 1983 trial that created modern transplantation
In plain words
Two hundred and nine people receiving a kidney from a deceased donor were randomly given the new drug or the existing combination. Four out of five kept the kidney for a year on cyclosporine, against roughly two out of three on the old regimen. Transplantation stopped being an experiment.
What was measured
Predicted graft and patient survival at one year, against azathioprine and prednisone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Canadian Multicentre Transplant Study Group randomised 209 recipients of cadaveric renal transplants to cyclosporine with prednisone or to standard therapy with azathioprine and prednisone. Predicted graft survival at one year was 80.4% against 64.0% (P=0.003) and predicted patient survival 96.6% against 86.4%. The trial also recorded the drug’s cost in the same paper: serum creatinine at 90 days was 2.6 mg/dL on cyclosporine against 2.0 on standard therapy (P=0.03), and graft survival on cyclosporine was worse where cold ischaemia exceeded 24 hours (70% against 88%, P=0.005) or the anastomosis took longer than 45 minutes (60% against 89%, P=0.002) — an interaction between the drug’s nephrotoxicity and pre-existing ischaemic injury.
Written into the record, not signed off as a reviewed claim
ELITE-Symphony: beaten by tacrolimus on every endpoint that mattered
In plain words
A four-arm trial in 1,645 kidney recipients compared two cyclosporine regimens against low-dose tacrolimus and low-dose sirolimus. Both cyclosporine arms came out behind tacrolimus on kidney function, rejection and graft survival. This is the trial that ended cyclosporine’s status as the default.
What was measured
GFR at 12 months, biopsy-proven acute rejection and allograft survival, four-arm randomised comparison
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Mean calculated glomerular filtration rate at 12 months, the primary endpoint, was 65.4 mL/min on low-dose tacrolimus against a range of 56.7 to 59.4 in the other three arms, which included standard-dose and low-dose cyclosporine. Biopsy-proven acute rejection was 25.8% on standard-dose cyclosporine and 24.0% on low-dose cyclosporine, against 12.3% on low-dose tacrolimus. Allograft survival differed significantly across arms (P=0.02): 93.1% low-dose cyclosporine, 89.3% standard-dose cyclosporine, 94.2% low-dose tacrolimus. The standard-dose cyclosporine arm was the only one without daclizumab induction, so it is a comparison of regimens rather than of molecules — but the low-dose cyclosporine arm, which did receive induction, still trailed tacrolimus on all three measures.
Written into the record, not signed off as a reviewed claim
CIRCUS: a promising 58-patient pilot that a 970-patient trial demolished
In plain words
A small trial suggested that giving cyclosporine just before opening a blocked coronary artery limited the damage to the heart muscle. It was published in a major journal and generated a decade of work. The definitive trial randomised 970 patients and found no difference at all in anything.
What was measured
That inhibiting the mitochondrial permeability transition pore limits reperfusion injury in humans — a mechanism supported by a biomarker and an imaging endpoint in 58 patients, and refuted on clinical outcomes in 970
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The pilot randomised 58 patients with ST-elevation myocardial infarction to an intravenous cyclosporine bolus of 2.5 mg/kg or saline before percutaneous coronary intervention. Creatine kinase release was significantly lower (P=0.04) and infarct mass on day-5 MRI in a 27-patient subgroup was 37 g against 46 g (P=0.04), though troponin I release was not significantly different (P=0.15). The authors described the data as preliminary and requiring confirmation. CIRCUS then randomised 970 patients with anterior STEMI, of whom 395 and 396 were evaluable, to the same intervention. The primary composite outcome at one year occurred in 59.0% against 58.1% (odds ratio 1.04, 95% CI 0.78 to 1.39, P=0.77). Cyclosporine did not reduce any separate component, including recurrent infarction, unstable angina and stroke, and did not prevent adverse left ventricular remodelling. Safety profiles did not differ.
Written into the record, not signed off as a reviewed claim
Severe ulcerative colitis: 9 of 11 against 0 of 9, in twenty patients
In plain words
Twenty people with ulcerative colitis so severe that steroids had failed and surgery was next were given intravenous cyclosporine or a placebo. Nine of eleven on the drug responded within about a week. None of nine on placebo did. It is one of the smallest trials that ever changed a standard of care.
What was measured
Clinical response permitting discharge on oral therapy, against placebo, in steroid-refractory disease
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A randomised, double-blind, controlled trial gave intravenous cyclosporine 4 mg/kg/day or placebo by continuous infusion to 20 patients with severe ulcerative colitis unimproved after at least 7 days of intravenous corticosteroids. Response, defined as symptom-score improvement allowing hospital discharge on oral medication, occurred in 9 of 11 (82%) on cyclosporine within a mean of seven days against 0 of 9 on placebo (P<0.001). Mean clinical activity score fell from 13 to 6 against 14 to 13. All five placebo non-responders who subsequently received open cyclosporine responded. Failure to respond meant colectomy, which is why the placebo arm could not be continued and why the trial is this small.
Written into the record, not signed off as a reviewed claim
The dry eye result is a sign, and the symptom evidence is thinner than the marketing
In plain words
The eye-drop trials measured how much the eye stained with dye and how far a paper strip wetted. Both improved against the vehicle. The things patients actually notice — burning, grittiness, dryness — mostly did not separate, and doubling the concentration did nothing at all.
What was measured
That an improvement in corneal staining and Schirmer score is an improvement in dry eye as a patient experiences it — the objective signs separated from vehicle, most patient-reported measures did not, and there was no dose-response
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Two identical multicentre, randomised, double-masked, vehicle-controlled six-month trials in 877 patients with moderate to severe dry eye compared cyclosporine ophthalmic emulsion 0.05% and 0.1% against vehicle. Both strengths gave significantly greater improvement than vehicle in two objective signs — corneal staining and categorised Schirmer values — at P at or below 0.05. The 0.05% strength additionally improved three subjective measures: blurred vision, need for concomitant artificial tears and the physician’s global response evaluation. The remaining subjective measures, including the Ocular Surface Disease Index and the patient rating scale, are not among the endpoints reported as significant. There was no dose-response effect between 0.05% and 0.1%, which is unusual for a real pharmacological effect and is a finding the paper reports plainly.
Written into the record, not signed off as a reviewed claim
The Restasis patents were assigned to a sovereign tribe, and it did not work
In plain words
Facing challenges to the patents on its dry-eye drops, Allergan transferred them to the Saint Regis Mohawk Tribe in 2017 and licensed them straight back, so the tribe’s sovereign immunity would block the challenge. A federal court held that sovereign immunity does not apply to that kind of review. The patents were separately found invalid, and a generic finally arrived in 2022.
What was measured
That patent term on a formulation of a 1970 molecule reflects the cost of developing it — the assignment to a sovereign tribe for the stated purpose of blocking validity review is difficult to characterise as anything other than a term-extension manoeuvre, and the courts treated it as one
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In September 2017 Allergan assigned six Restasis patents to the Saint Regis Mohawk Tribe of New York in exchange for payments, and took an exclusive licence back, with the express purpose of asserting tribal sovereign immunity as a bar to inter partes review at the Patent Trial and Appeal Board. In October 2017 the Eastern District of Texas held the patents invalid for obviousness. In July 2018 the Federal Circuit held in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals that tribal sovereign immunity cannot be asserted in inter partes review proceedings, and the Supreme Court denied certiorari in 2019. The first generic cyclosporine ophthalmic emulsion 0.05% was approved by the FDA in February 2022. The molecule dates from 1970 and the pivotal trials were published in 2000.
Source
Sall K et al., Ophthalmology 2000;107:631-639 (the pivotal trials whose product the patents covered); Drugs@FDA record for RESTASIS (cyclosporine ophthalmic emulsion), NDA 050790
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The pivotal trial reported the nephrotoxicity in the same paper as the benefit
In plain words
The 1983 trial did not hide the kidney damage. Creatinine was measurably worse on cyclosporine at ninety days, and grafts that had already suffered a long time without blood supply did substantially worse on the drug than on the old regimen. Both facts are in the abstract.
What was measured
Serum creatinine at 90 days, and graft survival stratified by cold ischaemia time and anastomosis time
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Serum creatinine 90 days after transplantation was 2.6 mg/dL on cyclosporine against 2.0 mg/dL on azathioprine and prednisone (P=0.03). Predicted one-year graft survival was worse on cyclosporine where the kidney had been machine-perfused for more than 24 hours (70% against 88%, P=0.005) or where the surgical anastomosis took longer than 45 minutes (60% against 89%, P=0.002). Lymphoma developed in one cyclosporine patient. The interaction with ischaemic injury is mechanistically coherent: cyclosporine constricts the afferent arteriole, and a kidney already injured by prolonged ischaemia has less reserve. That interaction, visible in the very first trial, is the origin of the entire subsequent literature on calcineurin inhibitor nephrotoxicity.
Written into the record, not signed off as a reviewed claim
Two formulations of the same molecule that are not interchangeable
In plain words
The original oil-based capsules were absorbed erratically, depending on how much bile the person happened to be producing. A microemulsion version fixed that. They contain the same drug and cannot be swapped one for one, and the label says so.
What was measured
That "cyclosporine" names one exposure profile — the oil-based and microemulsion formulations are explicitly not interchangeable, and much of the older transplant literature used the formulation with the erratic absorption
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Sandimmune, the original formulation, depends on bile for emulsification and gives absorption that varies substantially between and within patients, particularly in liver transplant recipients with impaired bile flow. Neoral is a self-microemulsifying preconcentrate that forms a fine dispersion on contact with aqueous fluid and gives markedly higher and more consistent bioavailability. The label states the two are not bioequivalent and must not be used interchangeably without physician supervision and blood level monitoring. The generic Gengraf is a modified formulation bioequivalent to Neoral, not to Sandimmune. A reader encountering "cyclosporine" in a paper, a guideline or a pharmacy record is encountering one of at least three products whose exposure profiles differ.
Source
NEORAL and SANDIMMUNE (cyclosporine) United States prescribing information, Description, Dosage and Administration and Clinical Pharmacology sections
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
24 documents were read for this substance.
RNAWiki source record
2 of them state the same bioavailability, and they agree.
RNAWiki source record
3 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
83HN0GTJ6D
CAS registry number
59865-13-3
PubChem compound
5284373
RxNorm concept
3008
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
37 approved applications cover products containing this substance. The earliest was NDA050573, approved 19831114 to NOVARTIS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
4 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A cyclic fungal peptide that binds cyclophilin and, as that complex, blocks calcineurin so T cells cannot transcribe interleukin-2 — it raised one-year kidney graft survival from 64.0% to 80.4% in 209 randomised patients and created modern transplantation, then came last or second-last on kidney function, rejection and graft survival against tacrolimus in a 1,645-patient four-arm trial, and failed outright in a 970-patient trial of reperfusion injury after heart attack (59.0% against 58.1%, odds ratio 1.04, 95% CI 0.78 to 1.39).
Recorded evidence blocks (14)
Q2
What did Ciclosporin's largest trial (2500 people) and its longest (26 years) measure?
2500 people in Ciclosporin's largest registered study, 26 years in its longest registered window, measuring Safety of establishing mixed chimerism using this non-lethal conditioning regimen, in terms of development of GVHD, myelosuppression, infections, and treatment-related mortality. ClinicalTrials.gov · 2026-09-01
217 phase2, 82 phase1, 65 phase3, 53 phase4, 38 na, 6 na or unstated, 3 early phase1; NCT00534430; 2026-02-02; no ageing endpoint recorded. Last human test completed 2026, NCT00534430.
Interpretation These counts include studies where Ciclosporin was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
217
phase1
82
phase3
65
phase4
53
na
38
na or unstated
6
2 more recorded rows
early phase1
3
Last recorded human testNCT00534430
2026-02-02
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Ciclosporin shown lifespan?
Interpretation Safety of establishing mixed chimerism using this non-lethal conditioning regimen, in terms of development of GVHD, myelosuppression, infections, and… — the recorded outcome words.
Show the evidence
NHP
mechanism-only
mouse
lifespan
rat
lifespan
dog
lifespan
humanNCT00003145
lifespan; Safety of establishing mixed chimerism using this non-lethal conditioning regimen, in terms of development of GVHD, myelosuppression, infections, and treatment-related mortality; 418
More Ciclosporin was worse in human: at what point?
Hormetic in human: "In the present study, the effect of radiation hormesis was evaluated on the survival rate of immunosuppressed BALB/c mice by Cyclosporine A." Europe PMC · dose-response search · 2022-10-31
5 recorded sentences naming Ciclosporin; hormesis, dose-response, biphasic
Show the evidence
hormesisPMID 27853721
"In the present study, the effect of radiation hormesis was evaluated on the survival rate of immunosuppressed BALB/c mice by Cyclosporine A."
dose-response
PMID 36315029
"One was a dose-response study comparing cyclosporine A to cyclosporine G, a formulation which was never licensed and is not clinically available."
PMID 36096417
"Immunobiogram dose-response curve parameters were compared between both subgroups in patients treated with mycophenolate, tacrolimus, corticosteroids, cyclosporine A or everolimus."
biphasic
PMID 31459882
"Cyclosporine was purified up to ∼93% with <i>n</i>-butylammonium acetate ([C<sub>4</sub>NH<sub>3</sub>][OAc]) and could be further purified to 95% using an IL/organic solvent biphasic system."
PMID 31536731
"A previously reported kinetic method for determining drug partitioning was used to quantitatively evaluate the drug distribution within a simplified biphasic (emulsion) system employing cyclosporine and difluprednate as model drugs."
recorded 2022-10-31 · last checked 2026-09-04
Q7
Which of adverse events, complete remission and complete remission rate did Ciclosporin's trials measure?
adverse events, complete remission and complete remission rate lead 40 outcome terms across Ciclosporin's trials. ClinicalTrials.gov · 2026-09-01
Interpretation overall response rate, rates of durable engraftment in, relapse rate for lymphoma after autologous transplant, who experienced transplant related mortality, safety and efficacy of sirolimus and non relapse mortality follow.
Show the evidence
event free survival
1
maximum tolerated dose
1
time to neutrophil engraftment
1
overall response rate
1
rates of durable engraftment in
1
relapse rate for lymphoma after autologous transplant
1
14 more recorded rows
who experienced transplant related mortality
1
safety and efficacy of sirolimus
1
non relapse mortality
1
transplant related mortality
1
disease free survival
1
partial or complete response
1
incidence of primary graft failure
1
immune response
1
adverse events
1
incidence of chronic gvhd
1
graft function measurnment
1
disease response
1
duration of remission
1
hematopoietic recovery
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ciclosporin's 17 ongoing trials reports first?
Neutrophil Engraftment - The Days Till ANC Recovery; Achievement of response; latest 2034-12
Show the evidence
Trial
NCT00544115
"Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders"; n 260; "Neutrophil Engraftment - The Days Till ANC Recovery"; 2027-03-29
NCT01624805
"Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome"; n 140; "Achievement of response"; 2029-06-30
NCT01659606
"Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita"; n 40; "Primary engraftment"; 2034-12
NCT03128034
"211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia"; n 75; "Incidence of dose limiting toxicity (DLT)"; 2029-03-31
NCT03970096
"Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)"; n 120; "Graft versus host disease (GVHD)-free relapse-free survival (RFS)"; 2029-12-31
NCT04195633
"Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies"; n 60; "Graft failure/rejection"; 2029-03-12
11 further recorded trials
NCT04375631
"CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia"; n 120; "Rate of hematopoietic cell transplantation (HCT) failure"; 2027-03-17
NCT05303727
"Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"; n 64; "overall survival(OS) at 3 year"; 2027-08
NCT05674695
"Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy"; n 2500; "Rates of adverse events"; 2029-01-01
NCT05867329
"Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis"; n 700; "Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during first stage of therapy"; 2027-11
NCT06013423
"Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases"; n 54; "Overall survival"; 2032-10-31
NCT06752694
"Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia"; n 1; "Incidence of grades II-IV acute graft-versus-host disease (GVHD)"; 2026-10-15
NCT06790095
"TRACK-TBI Precision Medicine Part 3 - Option II"; n 26; "Change in Disability Rating Score (DRS)"; 2027-03
NCT06942793
"A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients"; n 396; "Eye Dryness Score(EDS)"; 2025-11-15
NCT07169695
"A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis"; n 120; "Change from baseline (Day 1) at Day 29 (Week 4) in Corneal Fluorescein Staining (CFS) grade assessed by the (0-5) modified Oxford scale in the study eye."; 2027-01-21
NCT07377058
"RCT of Tocilizumab for Anti-MDA5+DM"; n 110; "TIS improvement"; 2026-10
NCT07774325
"A Study in Healthy Men to Find Out How Blocking Certain Transport Proteins Affects the Amount of BI 3000202 in the Blood"; n 16; "Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)"; 2026-10-26
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Ciclosporin could settle lifespan?
NCT05303727 measures overall survival(OS) at 3 year, reading out 2027-08.
3 open trials; n 64; "Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"
Show the evidence
Trial
NCT05303727
"Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"; n 64; "overall survival(OS) at 3 year"; 2027-08
NCT03970096
"Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)"; n 120; "Graft versus host disease (GVHD)-free relapse-free survival (RFS)"; 2029-12-31
NCT06013423
"Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases"; n 54; "Overall survival"; 2032-10-31
Q10
Which 142 trials of Ciclosporin posted no result?
Posted no result
142 of 142 completed trials
Registrations
NCT00000524, NCT00000880, NCT00001839, NCT00001533, NCT00005854 and NCT00003662, and 136 more
Completion dates
oldest 1994-03; newest 2024-06-05
Show the evidence
Trial
NCT00000524
1994-03
NCT00000880
2000-05
NCT00001839
2000-05
NCT00001533
2000-09
NCT00005854
2000-10
NCT00003662
2001-01
14 further recorded trials
NCT00518375
2001-05
NCT00002789
2001-09
NCT00002832
2002-03
NCT00005935
2002-03
NCT00005988
2002-03-08
NCT00002456
2002-04
NCT00002833
2002-04
NCT00003196
2002-04
NCT00507793
2002-06
NCT00008151
2002-07
NCT00004232
2002-10
NCT00002831
2002-12-31
NCT00268515
2003-03
NCT00002792
2003-04
Q11
At the median, Ciclosporin's trials enrolled 40 people — anything larger?
Median enrolment
40
Largest enrolment
2500
Registered trials counted
386
Q12
What do 18699 spontaneous reports say about Ciclosporin — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Ciclosporin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 18699 reaction mentions were counted: cytomegalovirus infection 2670; transplant rejection 2429; acute kidney injury 2190; blood creatinine increased 2168. open-targets-adr · CHEMBL160 · 2026-06-24
Show the evidence
cytomegalovirus infection
2670
transplant rejection
2429
acute kidney injury
2190
blood creatinine increased
2168
renal impairment
2127
toxicity to various agents
1965
4 more recorded rows
post transplant lymphoproliferative disorder
1535
kidney transplant rejection
1253
acute graft versus host disease
1181
thrombotic microangiopathy
1181
recorded 2026-06-24 · last checked 2026-09-04
Q13
Ciclosporin and P-glycoprotein, CYP3A4 and CYP 3A: shared by which compounds?
P-glycoprotein, CYP3A4 and CYP 3A appear in Ciclosporin's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-10
Interpretation drug_interactions
Show the evidence
CYP 3Adrug_interactions
Cyclosporine is extensively metabolized by CYP 3A isoenzymes, in particular CYP3A4, and is a substrate of the multidrug efflux transporter P-glycoprotein.
CYP3A4
drug_interactions
Various agents are known to either increase or decrease plasma or whole blood concentrations of cyclosporine usually by inhibition or induction of CYP3A4 or P-glycoprotein transporter or both.
drug_interactions
B. Effect of Cyclosporine on the Pharmacokinetics and/or Safety of Other Drugs or Agents Cyclosporine is an inhibitor of CYP3A4 and of multiple drug efflux transporters (e.g., P-glycoprotein) and may increase plasma concentrations of comedications that are substrates of CYP3A4, P-glycoprotein or organic anion transporter proteins.
drug_interactions
Aliskiren Cyclosporine alters the pharmacokinetics of aliskiren, a substrate of P-glycoprotein and CYP3A4.
recorded 2026-08-10 · last checked 2026-09-04
Q14
Was Ciclosporin studied with fasting?
fasting is named in Ciclosporin's label sentences: "A randomized, open-label, repeated-measurement, comparative phase IV trial was conducted with two sequence groups for nutrition condition (fasting→fed, fed→fasting) and two treatment phases (Sandimmun® Optoral → Ciclosporin Pro), each covering both nutrition conditions." openfda-label+europepmc · 2026-08-10
1 recorded statement; fasting
Show the evidence
fasting
A randomized, open-label, repeated-measurement, comparative phase IV trial was conducted with two sequence groups for nutrition condition (fasting→fed, fed→fasting) and two treatment phases (Sandimmun® Optoral → Ciclosporin Pro), each covering both nutrition conditions.
recorded 2026-08-10 · last checked 2026-09-04
Q15
What is recorded about Ciclosporin and mTOR?
"Rats were administered oral Cyclosporine A (25 mg/kg/day) for nephrotoxicity and treated with either CLZ or CGF for 21 days at doses (10 mg/kg/day and 20 mg/kg/day) for both one hour before Cyclosporine A administration Rats were evaluated for body weight, serum renal injury biomarkers, histopathology, immunohistochemistry,…" — where Ciclosporin and mTOR appear together. Europe PMC · pathway abstract search · 2026-07-27
"Rats were administered oral Cyclosporine A (25 mg/kg/day) for nephrotoxicity and treated with either CLZ or CGF for 21 days at doses (10 mg/kg/day and 20 mg/kg/day) for both one hour before Cyclosporine A administration Rats were evaluated for body weight, serum renal injury biomarkers, histopathology, immunohistochemistry, histomorphometry, and mRNA and protein expression levels of six…"
AMPKPMID 41172958
"Rats were administered oral Cyclosporine A (25 mg/kg/day) for nephrotoxicity and treated with either CLZ or CGF for 21 days at doses (10 mg/kg/day and 20 mg/kg/day) for both one hour before Cyclosporine A administration Rats were evaluated for body weight, serum renal injury biomarkers, histopathology, immunohistochemistry, histomorphometry, and mRNA and protein expression levels of six…"
mTORPMID 42509384
"Interventions included Ca<sup>2+</sup> chelation (BAPTA-AM), endoplasmic reticulum (ER) stress inhibitor 4-phenylbutyrate, mammalian target of rapamycin (mTOR) inhibitor rapamycin, redox modulator Tempol, calcineurin inhibitor cyclosporine A, peroxisome-proliferator-activated receptor γ (PPARγ) agonist pioglitazone, and SERCA2 agonist [6]-gingerol."
AMPKPMID 41548681
"Notably, after inhibiting AMPK-mediated mitophagy using compound C or cyclosporine A in vitro, the anti-inflammatory effects of ORI were inhibited and the expression of contraction-related proteins were down-regulated."
autophagyPMID 41400318
"The purpose of this research was to examine the roles and regulatory mechanisms of autophagy and the cyclic GMP-AMP synthase (cGAS)-stimulator of interferon gene (STING) pathway in dry eye (DE) inflammation and the mechanism by which cyclosporine A (CsA) attenuates the inflammatory response in dry eye disease (DED) by modulating autophagy and the cGAS-STING pathway."
IGF-1PMID 41471311
"Analyzed were the ascorbate, fibronectin, hyaluronic acid, metalloproteinase inhibitors, EGF, FGF, NGF, insulin, and IGF-1 (corneal ulcer healing), the antiangiogenic agents (endostatin, PAI-1, PEDF, angiostatin, TSP-1, TSP-2, IFN-α), corticosteroids, NSAIDs, cyclosporine A, anti-VEGF drops (treatment of corneal neovascularization), and alpha 2-agonists, beta-blockers, carboanhydrase inhibitors,…"
4 more recorded rows
autophagyPMID 39489201
"In vitro, SKF96365 and AncoA4 were used to inhibit STIM1-administrated Ca<sup>2+</sup> entry of SiHa cells, Cyclosporine A (calcineurin inhibitors) were used to inhibit CaN/TFEB pathway, Ad-mCherry-GFPLC3B was used to detect autophagy flux, shSTIM1 was used to knockdown STIM1 expression."
NAD+PMID 41854947
"Bioenergetic support with L-carnitine, NAD<sup>+</sup> precursors, coenzyme Q10, deoxyarbutin, and melatonin restored ATP levels and stabilized ΔΨm, while ΔΨm preservation and mPTP modulation by irisin, cyclosporine/NIM811, and TRO40303 limited necrosis."
mTORPMID 40066607
"The standard immunosuppressive treatment after organ transplantation typically includes a calcineurin inhibitor (tacrolimus or cyclosporine A), an antimetabolite (mycophenolic acid) or an mTOR inhibitor, and corticosteroids."
autophagyPMID 39340591
"The mechanistic exploration revealed that HCQ, in conjunction with the mitochondrial autophagy inhibitor Cyclosporine A (CsA), exacerbated the inhibitory effects of UA on HUVEC autophagy."
recorded 2026-07-27 · last checked 2026-09-04
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