This page shows what was measured, who it was measured in, and what that does not settle.
What Sirolimus does in the body
Lymphangioleiomyomatosis ( 1
From the FDA-approved label: Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin [IL]-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from that of other immunosuppressants. Sirolimus also inhibits antibody production. In cells, sirolimus binds to the immunophilin, FK Binding Protein-12 (FKBP-12), to generate an immunosuppressive complex. The sirolimus:FKBP-12 complex has no effect on calcineurin activity. This complex binds to and inhibits the activation of the mammalian target of rapamycin (mTOR), a key regulatory kinase.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · W36ZG6FT64 · read 2026-08-29
Its recorded molecular formula is C51H79NO13, weighing 914.2.
US prescribing information · 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 101 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
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 reviewer1 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.
Which registered measures put each goal on this table
Healthy ageing
non relapse mortality at 200 days
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
1 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.
MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT
✗ The study did not show it
Who was studied
NCT00977938
How many people
25682
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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 limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)
✗ The study did not show it
Who was studied
NCT00438919
How many people
15000
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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 limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation
✗ The study did not show it
Who was studied
NCT00476957
How many people
8709
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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 limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
all cause mortality
✗ The study did not show it
Who was studied
NCT01233167
How many people
5232
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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 limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
rate of major adverse cardiac events
✗ The study did not show it
Who was studied
NCT00868829
How many people
5000
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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 limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
✗ The study did not show it
Who was studied
NCT02693535
How many people
4200
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
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 limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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.11 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 healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.2 registered measures inside human tissue.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Drosophila (fruit fly), Mouse, 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 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.
creatinine clearance rate
biopsy confirmed acute rejection at 12 months follow up
serum creatinine at 6 months
biopsy proven acute rejection
serum creatinine
Meaningful
Things that change how a life goes, not only a number.
graft survival
overall survival at one year post kidney transplant
overall kidney graft survival at one year post transplant
one year graft survival
one year survival
6 month overall survival
non relapse mortality at 200 days
progression free survival
recurrence free survival
estimated percentage of event free survival
and 1 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 (24)
nankivell glomerular filtration rate
engraftment
toxicity
maximum tolerated dose
rate of allograft rejection
acute rejections in all enrolled
grades ii iv acute gvhd
glomerular filtration rate at 12 months posttransplant
glomerular filtration rate from baseline to month 12
objective response rate
renal function
safety evaluation
response rate
adverse events
modified rodnan skin thickness
transplantation
monthly rates of anti vegf injections
tpv at pre conversion baseline
dose limiting toxicity and maximum tolerated dose
acute rejection at 6 months
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.
Sirolimus oral solution is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation ( 1.1 ).
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.
What the label states about particular groups
On pediatric, the label states: “Renal Transplant The safety and efficacy of sirolimus in pediatric patients <13 years have not been established.”
US prescribing information · 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5 · read 2026-08-30
On older people, the label states: “Clinical studies of sirolimus oral solution or Tablets did not include sufficient numbers of patients ≥65 years to determine whether they respond differently from younger patients.”
US prescribing information · 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on animal studies and the mechanism of action, sirolimus can cause fetal harm when administered to a pregnant woman [ see Data, Clinical Pharmacology ( 12.1 ) ].”
US prescribing information · 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary It is not known whether sirolimus is present in human milk.”
US prescribing information · 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5 · read 2026-08-30
Where the result stopped carrying
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
Prescription only
❝ 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
Oral
✎ 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, S3, S4, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, cream, solution, powder, given by the oral, topical, intravenous route.
✎ 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∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
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.
Sirolimus appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10746 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
Oral
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
67 products list this as an active ingredient in the United States drug directory. 67 of them contain it and nothing else.
FDA National Drug Code directory · 72205-099 · read 2026-08-29
They are sold as gel, injection, powder, lyophilized, for suspension, powder, solution, suspension and tablet, taken intravenous, oral and topical.
FDA National Drug Code directory · 72205-099 · read 2026-08-29
The regulator's established pharmacologic class for it is decreased immunologic activity [pe], kinase inhibitor [epc] and protein kinase inhibitors [moa].
FDA National Drug Code directory · 72205-099 · read 2026-08-29
26 published labels name it as an active ingredient. 26 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 82562b68-224d-482a-b399-a89b81d5eb31 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 82562b68-224d-482a-b399-a89b81d5eb31 · read 2026-08-29
sirolimus is oral at 3 DOSAGE FORMS AND STRENGTHS • Oral Solution: 60 mg per 60 mL in amber glass bottle ( 3.1 ). 3.1 Sirolimus Oral Solution 60 mg per 60 mL in amber glass bottle., recorded as fda label in effect 2025-03-21 in the United States.
US prescribing information · 580c1ec1-c1f5-45f6-89b7-3be25c07a0e5 · read 2026-08-30
Recorded price in US: 0.83503–2.64129 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 24 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
Recorded price in US: 4.56328 USD per one millilitre, across 10 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 Sirolimus 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
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 Sirolimus 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.
How many documents were read
25 documents were read for this substance.
RNAWiki source record
22 of them state the same bioavailability, and they agree.
RNAWiki source record
23 of them state the same tMax, and they agree.
RNAWiki source record
23 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
W36ZG6FT64
RxNorm concept
314230
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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
16 approved applications cover products containing this substance. The earliest was NDA021083, approved 19990915 to PF PRISM CV.
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6 questions this page could not answer
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Recorded evidence blocks (16)
Q2
What did Sirolimus's largest trial (1209 people) and its longest (30 years) measure?
1209 people in Sirolimus's largest registered study, 30 years in its longest registered window, measuring Non-relapse mortality (NRM) at 200 days. ClinicalTrials.gov · 2026-09-01
279 phase2, 178 phase1, 69 phase3, 65 phase4, 26 na, 19 na or unstated, 14 early phase1; NCT06358638; 2054-09. Last human test completed 2025, NCT04339101.
Interpretation These counts include studies where Sirolimus 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
279
phase1
178
phase3
69
phase4
65
na
26
na or unstated
19
2 more recorded rows
early phase1
14
Last recorded human testNCT04339101
2025-10-09
recorded 2026-09-01 · last checked 2026-09-04
Q3
From C. elegans to human: where has Sirolimus shown lifespan?
Non-relapse mortality (NRM) at 200 days — the recorded outcome words.
Show the evidence
C. elegans
lifespan
Drosophila
lifespan
NHP
lifespan
mouse
lifespan
dog
lifespan
humanNCT00317785
lifespan; Non-relapse mortality (NRM) at 200 days; 542
recorded 2026-09-01 · last checked 2026-09-04
Q4
The NIA ITP gave Sirolimus at 14 ppm, 42 ppm, 4.7 ppm, Met: 1000, Rapa: 14 and Rapa: 14.7 and ACA: 1000 from 20, 9 and 16 months — did both sexes live longer?
3278 mice; cohorts C2005, C2006, C2009, C2011, C2015, C2017; cohort rows are the workbook's own printed values; no median, percent change or survival statistic is derived from the per-animal data
Show the evidence
ITP cohort
C2005
rapamycin; 14; 20.0 months; f, m; ITP_C2005_Lifespan.xlsx
C2006
rapamycin; 14; 9.0 months; f, m; ITP_C2006_Lifespan.xlsx
C2009
rapamycin; 42.0; 9.0 months; f, m; ITP_C2009_Lifespan.xlsx
C2009
rapamycin; 4.7; 9.0 months; f, m; ITP_C2009_Lifespan.xlsx
C2009
rapamycin; 14.0; 9.0 months; f, m; ITP_C2009_Lifespan.xlsx
C2011
metformin plus rapamycin; Met: 1000, Rapa: 14; 9 months; f, m; ITP_C2011_Lifespan.xlsx
5 more recorded rows
ITP cohortC2015
rapamycin; 42; 20 months; f, m; ITP_C2015_Lifespan.xlsx
ITP cohortC2015
rapamycin; 42; 20 but every other months; f, m; ITP_C2015_Lifespan.xlsx
ITP cohortC2015
rapamycin; 42; 20 thru 23 months; f, m; ITP_C2015_Lifespan.xlsx
ITP cohortC2017
rapamycin plus acarbose; Rapa: 14.7 and ACA: 1000; 16.0 months; f, m; ITP_C2017_Lifespan.xlsx
ITP cohortC2017
rapamycin plus acarbose; Rapa: 14.7 and ACA: 1000; 9.0 months; f, m; ITP_C2017_Lifespan.xlsx
"Inability to meet the accrual target of 213."; 78 of 542 registered studies
Show the evidence
Trial
NCT00005113
terminated; "Inability to meet the accrual target of 213."
NCT00023244
terminated; "Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder"
NCT00068302
terminated; "Recruiting/enrolling participants halted prematurely but potentially will resume"
NCT00095329
terminated; "Due to slow recruitment."
NCT00098462
withdrawn; "Withdrawn as study never opened"
NCT00166712
terminated; "Study stopped due to lack of efficacy \& funding."
14 further recorded trials
NCT00276744
terminated; "Because there was no longer an active laboratory component to this study."
NCT00311311
terminated; "See termination reason in detailed description."
NCT00346151
terminated; "Stopping rule-acute rejection threshold-was met based on local biopsy results"
NCT00358657
terminated; "Low accrual"
NCT00468442
terminated; "Lack of efficacy"
NCT00473551
terminated; "Terminated due to slow accrual."
NCT00489281
terminated; "Initiation of CMS BMT study for sickle-cell disease operating under NCT01166009 made further accrual to this study impossible."
NCT00506948
terminated; "Halted due to high incidence of veno-oclusive disease of the liver."
NCT00548717
terminated; "First two patients enrolled after trial reopened, developed grade III-IV acute GVHD and subsequently passed away."
NCT00623012
terminated; "Low accrual"
NCT00672204
terminated; "Raptiva was withdrawn from the market"
NCT00790439
withdrawn; "Due to funding limitations"
NCT00811915
terminated; "Difficulty in enrolling new patients"
NCT00866684
terminated; "Insufficient patient recruitment"
recorded 2026-09-01 · last checked 2026-09-04
Q6
Mouse studies of Sirolimus used 14 ppm — over how long?
studies of Sirolimus used the recorded amount. clinicaltrials.gov+jax-mpd-itp · 2026-09-04
26 recorded entries; mouse, human; also "14 ppm", "4.7 (lo), 14 (mid), and 42 (hi) ppm", "Met: 1000 ppm and Rapa: 14 ppm"
Show the evidence
mouse
rapamycin C2005
14 ppm
rapamycin C2006
14 ppm
rapamycin C2009
4.7 (lo), 14 (mid), and 42 (hi) ppm
rapamycin C2009
4.7 (lo), 14 (mid), and 42 (hi) ppm
rapamycin C2009
4.7 (lo), 14 (mid), and 42 (hi) ppm
metformin plus rapamycin C2011
Met: 1000 ppm and Rapa: 14 ppm
5 more recorded rows
mouserapamycin C2015
42 ppm
mouserapamycin C2015
42 ppm
mouserapamycin C2015
42 ppm
mouserapamycin plus acarbose C2017
Rapa: 14.7 ppm and ACA: 1000 ppm
mouserapamycin plus acarbose C2017
Rapa: 14.7 ppm and ACA: 1000 ppm
human
NCT01620307
Sirolimus (Rapamune 2mg/day, Pfizer)
NCT03304678
Sirolimus 2mg
NCT03589976
Sirolimus 2 MG
NCT03877809
Sirolimus 0.5 mg
NCT03972462
NPC-12G Gel 0.2%
NCT03972462
2 mg of sirolimus in 1 g of gel
3 more recorded rows
humanNCT04077515
Sirolimus(0.8mg/m2)
humanNCT04077515
Sirolimus(0.7mg/m2)
humanNCT04393454
Sirolimus 2mg Tablet
recorded 2026-09-04 · last checked 2026-09-04
Q7
Did Sirolimus move PhenoAge, and by how much?
PhenoAge: "We present a review of the evidence for low dose rapamycin and rapalog therapies in healthy human adults and model the findings of one cohort study using the PhenoAge model." Europe PMC · epigenetic clock search · 2025-08-07
3 recorded sentences; 2025, 2021; biomarker
Show the evidence
PhenoAgePMID 40778880
2025; "We present a review of the evidence for low dose rapamycin and rapalog therapies in healthy human adults and model the findings of one cohort study using the PhenoAge model."
epigenetic clockPMID 34482522
2021; "In a separate cohort of marmosets, we tested whether intervention with rapamycin, a drug shown to extend lifespan in mice, would alter the epigenetic age of marmosets, as measured by the marmoset epigenetic clocks."
epigenetic agePMID 34482522
2021; "These clocks did not detect significant effects of rapamycin on the epigenetic age of marmoset blood."
recorded 2025-08-07 · last checked 2026-09-04
Q8
More Sirolimus was worse in human: at what point?
Hormetic in human: "This insight is applied to explain how hormesis exhibited during long-term rapamycin treatment arises directly from the structure of the network of interactions that form the mTOR-Pi3K-Akt signaling pathway." Europe PMC · dose-response search · 2026-05-31
8 recorded sentences naming Sirolimus; hormesis, hormetic, biphasic, Dose-response
Show the evidence
hormesis
"This insight is applied to explain how hormesis exhibited during long-term rapamycin treatment arises directly from the structure of the network of interactions that form the mTOR-Pi3K-Akt signaling pathway."
hormetic
PMID 34739690
"Rapamycin is hormetic in nature-it demonstrates contrasting effects at high and low doses."
PMID 34739690
"Although previous studies have suggested that hormetic (low) doses of rapamycin can cause partial/incomplete inhibition of mTOR, the actual modus operandi of how such partial mTOR inhibition might modulate the mTOR-mitochondria cross-talk remained to be deciphered in the context of cellular aging."
PMID 34739690
"The present study was designed to understand the hormetic effects of rapamycin on cellular factors that govern aging-associated changes in mitochondrial facets, such as functional and metabolic homeostases, sustenance of membrane potential, biogenesis, mitophagy, and oxidative injury to mitochondrial macromolecules."
PMID 34739690
"We demonstrated that hormetic doses (0.1 and 1 nM) of rapamycin can alleviate aging-associated mitochondrial dyshomeostasis in WRL-68 cells, such as oxidative injury to mitochondrial nucleic acids and proteins, as well as disequilibrium of mitochondrial density, membrane potential, biogenesis, mitophagy and overall metabolism."
PMID 34739690
"We established that low doses of rapamycin can hormetically amend the mTOR-mitochondria cross-talk, and can consequently promote anti-aging outcome in cells."
biphasicPMID 42200537
"This device introduces a hybrid design featuring 73 μm struts with abluminal phospholipid coating providing biphasic sirolimus release over 40 days with prolonged in-tissue exposure, alongside fusion coating covering platform, gaps, and edge zones."
Dose-response
"Dose-response meta-regression assessed whether rapamycin-associated changes scaled with dose (42–990 mg/kg), integrating presence and magnitude of effects across heterogeneous study designs."
recorded 2026-05-31 · last checked 2026-09-04
Q9
Which of 6 month overall survival, acute rejection at 6 months and acute rejections in all enrolled did Sirolimus's trials measure?
6 month overall survival, acute rejection at 6 months and acute rejections in all enrolled lead 40 outcome terms across Sirolimus's trials. ClinicalTrials.gov · 2026-09-01
maximum tolerated dose, rate of allograft rejection, acute rejections in all enrolled, graft survival, grades ii iv acute gvhd and glomerular filtration rate at 12 months posttransplant follow.
Show the evidence
nankivell glomerular filtration rate
1
engraftment
1
toxicity
1
maximum tolerated dose
1
rate of allograft rejection
1
acute rejections in all enrolled
1
14 more recorded rows
graft survival
1
grades ii iv acute gvhd
1
glomerular filtration rate at 12 months posttransplant
1
glomerular filtration rate from baseline to month 12
1
objective response rate
1
renal function
1
overall survival at one year post kidney transplant
1
overall kidney graft survival at one year post transplant
1
one year graft survival
1
one year survival
1
creatinine clearance rate
1
biopsy confirmed acute rejection at 12 months follow up
1
safety evaluation
1
response rate
1
recorded 2026-09-01 · last checked 2026-09-04
Q10
Which of Sirolimus's 115 ongoing trials reports first?
Describe natural history; Neutrophil Engraftment - The Days Till ANC Recovery; latest 2054-09
Show the evidence
Trial
NCT00092222
"Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity"; n 75; "Describe natural history"; 2026-10-01
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
NCT00679042
"Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol"; n 21; "Treatment Emergent Adverse Events"; 2026-06-14
NCT00792948
"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia"; n 97; "Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation"; 2027-01-06
NCT00977691
"Haploidentical PBMC Transplant for Severe Congenital Anemias"; n 23; "Patients With Donor Type Hemoglobin"; 2026-09-10
NCT01087554
"Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer"; n 249; "Maximum Tolerated Dose (MTD)"; 2026-08-18
14 further recorded trials
NCT01499888
"Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD)"; n 45; "To determine the engraftment after non-myeloablative HSC transplant"; 2029-10
NCT01885689
"Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia"; n 72; "Progression-free Survival at 2 Years"; 2026-09-21
NCT02042326
"Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations"; n 50; "Treatment efficacy at M12"; 2027-09
NCT02105766
"Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure"; n 56; "Number of Patients Who Have Sustained Donor Type Hemoglobin at One Year Post Transplant"; 2027-12-31
NCT02432560
"Safety and Durability of Sirolimus for Treatment of LAM"; n 600; "Long term safety of mTOR inhibitor treatment in LAM"; 2025-07-31
NCT02574728
"Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors"; n 46; "Radiographic response to treatment for solid tumors"; 2026-06
NCT02629120
"High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease"; n 45; "To determine engraftment rates with the use of high cell doses, without increasing the risk of GvHD by using post-transplant cyclophosphamide and sirolimus in conjunction with a busulfan- based conditioning regimen. We will compare the…"; 2028-12-30
NCT02638389
"Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care"; n 250; "Self-assesment (or parent assesment), using visual anagogic scale (0-10) of efficacy of sirolimus"; 2030-04-01
NCT02790515
"Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation"; n 170; "The number of patients engrafted by day +30 post-transplant"; 2026-07-01
NCT02979873
"Sirolimus (Rapamune ) for Relapse Prevention in People With Severe Aplastic Anemia Responsive to Immunosuppressive Therapy"; n 84; "To determine if the rate of relapse at 24 months after CSA discontinuation can be improved by conversion to sirolimus in severe aplastic anemia patients who have responded to IST."; 2030-06-30
NCT03077542
"Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease"; n 57; "Percentage of Participants Who Have Not Rejected Their Stem Cell Graft and Who Are Without Severe Graft-versus-host Disease Following Stem Cell Transplant"; 2026-08-31
NCT03099356
"Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer"; n 22; "Percentage of patients that respond to treatment"; 2026-12
NCT03121001
"Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease"; n 50; "Estimate the number of patients who engraft by Day +60"; 2029-05
NCT03150914
"Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial"; n 60; "Forced Expiratory Volume in 1 Second (FEV1 slope)"; 2025-06-30
recorded 2026-09-01 · last checked 2026-09-04
Q11
Which running trial of Sirolimus could settle vo2max?
NCT07475546 measures Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max), reading out 2026-04.
15 open trials; n 30; "Combination Gerotherapeutic Interventions for Healthspan Improvement"
Show the evidence
Trial
NCT07475546
"Combination Gerotherapeutic Interventions for Healthspan Improvement"; n 30; "Change in cardiorespiratory fitness measured by maximal oxygen uptake (VO₂ max)"; 2026-04
NCT01885689
"Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia"; n 72; "Progression-free Survival at 2 Years"; 2026-09-21
NCT06084780
"Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)"; n 20; "Overall Rate of Survival"; 2026-12-31
NCT00792948
"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia"; n 97; "Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation"; 2027-01-06
NCT04888741
"Methods of T Cell Depletion Trial (MoTD)"; n 400; "GVHD-free, relapse-free survival"; 2027-08-23
NCT06929325
"Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors"; n 312; "Progression-free Survival（PFS）"; 2027-12
9 further recorded trials
NCT05088356
"Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft"; n 66; "Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)"; 2028-05
NCT05436418
"The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation"; n 260; "Phase II: Evaluate the efficacy of PTCy, at the lowest dose determined for each HLA-matching arm from phase I, as assessed by 1-year GVHD-free relapse-free survival (GRFS) rate."; 2028-06-25
NCT06236022
"The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus"; n 276; "Cardiac mortality"; 2028-12-31
NCT04469530
"Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors"; n 55; "Two-year progression-free survival in patients with high-risk solid tumors"; 2029-02
NCT07582172
"Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome"; n 35; "Leukemia-free survival"; 2029-04-05
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
NCT05463133
"Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists"; n 50; "Overall Survival"; 2032-12-31
NCT07616154
"Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease"; n 45; "GVHD-free and rejection free survival (GRFS)"; 2035-09
NCT06358638
"Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody"; n 12; "To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies."; 2054-09
Q12
Which 148 trials of Sirolimus posted no result?
Posted no result
148 of 148 completed trials
Registrations
NCT00518375, NCT00519116, NCT00507793, NCT00518271, NCT00146614 and NCT00859183, and 142 more
Completion dates
oldest 2001-05; newest 2024-08-19
Show the evidence
Trial
NCT00518375
2001-05
NCT00519116
2001-08
NCT00507793
2002-06
NCT00518271
2002-06
NCT00146614
2003-04
NCT00859183
2004-03
14 further recorded trials
NCT00428064
2004-06
NCT00470665
2004-07
NCT00037531
2004-08
NCT00040508
2005-01
NCT00261820
2005-01
NCT00305396
2005-03
NCT00089037
2005-04
NCT00044720
2005-07
NCT00812123
2005-07
NCT00254709
2005-09
NCT00195481
2005-12
NCT00144677
2006-06
NCT00241189
2006-06
NCT00023231
2006-08
Q13
At the median, Sirolimus's trials enrolled 37 people — anything larger?
Median enrolment
37
Largest enrolment
1209
Registered trials counted
537
Q14
What do 10746 spontaneous reports say about Sirolimus — 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.
Sirolimus appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10746 reaction mentions were counted: diarrhoea 1853; stomatitis 1545; malignant neoplasm progression 1432; pyrexia 1152. open-targets-adr · CHEMBL413 · 2026-06-24
Show the evidence
diarrhoea
1853
stomatitis
1545
malignant neoplasm progression
1432
pyrexia
1152
pneumonia
1012
cough
907
4 more recorded rows
decreased appetite
868
transplant rejection
686
pneumonitis
683
disease progression
608
recorded 2026-06-24 · last checked 2026-09-04
Q15
Sirolimus and CYP3A4 and P-GP: shared by which compounds?
CYP3A4 and P-GP appear in Sirolimus's recorded interaction sentences, 15 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP3A4
pharmacokinetics
Cyclosporine: Cyclosporine is a substrate and inhibitor of CYP3A4 and P-gp.
pharmacokinetics
Diltiazem: Diltiazem is a substrate and inhibitor of CYP3A4 and P-gp; sirolimus concentrations should be monitored and a dose adjustment may be necessary [ see Drug Interactions ( 7.4 ) ].
pharmacokinetics
Erythromycin: Erythromycin is a substrate and inhibitor of CYP3A4 and P-gp; co-administration of sirolimus oral solution or tablets and erythromycin is not recommended [ see Warnings and Precautions ( 5.20 ), Drug Interactions ( 7.2 ) ].
pharmacokinetics
Verapamil: Verapamil is a substrate and inhibitor of CYP3A4 and P-gp; sirolimus concentrations should be monitored and a dose adjustment may be necessary; [ see Drug Interactions ( 7.4 ) ].
pharmacokinetics
In patients in whom strong inhibitors or inducers of CYP3A4 are indicated, alternative therapeutic agents with less potential for inhibition or induction of CYP3A4 should be considered.
pharmacokinetics
Care should be exercised when drugs or other substances that are substrates and/or inhibitors or inducers of CYP3A4 are administered concomitantly with sirolimus.
9 more recorded rows
CYP3A4pharmacokinetics
Other Drug-Food Interactions Grapefruit juice reduces CYP3A4-mediated drug metabolism.
CYP3A4pharmacokinetics
Inducers of CYP3A4 and P-gp decrease sirolimus concentrations [ see Warnings and Precautions ( 5.20 ) and Drug Interactions ( 7 ) ].
CYP3A4pharmacokinetics
Drug-Herb Interactions St. John’s Wort ( Hypericum perforatum ) induces CYP3A4 and P-gp.
CYP3A4pharmacokinetics
Rifampin: Rifampin is a strong inducer of CYP3A4 and P-gp; co-administration of sirolimus oral solution or tablets and rifampin is not recommended.
CYP3A4pharmacokinetics
Inhibitors of CYP3A4 and P-gp increase sirolimus concentrations.
CYP3A4pharmacokinetics
Ketoconazole: Ketoconazole is a strong inhibitor of CYP3A4 and P-gp; co-administration of sirolimus oral solution or tablets and ketoconazole is not recommended [ see Warnings and Precautions ( 5.20 ), Drug Interactions ( 7.2 ) ].
CYP3A4pharmacokinetics
Metabolism Sirolimus is a substrate for both CYP3A4 and P-gp.
CYP3A4pharmacokinetics
Drug-Drug Interactions Sirolimus is known to be a substrate for both cytochrome CYP3A4 and P-gp.
CYP3A4pharmacokinetics
Since sirolimus is a substrate for both cytochrome CYP3A4 and P-gp, there is the potential that the use of St. John’s Wort in patients receiving sirolimus could result in reduced sirolimus concentrations [ see Drug Interactions ( 7.4 ) ].
recorded 2026-08-30 · last checked 2026-09-04
Q16
Was Sirolimus studied with exercise?
exercise is named in Sirolimus's label sentences: "This exploratory trial assessed whether once-weekly sirolimus (rapamycin) 6 mg enhances or inhibits functional gains from a home-based exercise programme." openfda-label+europepmc · 2026-08-30
1 recorded statement; exercise
Show the evidence
exercise
This exploratory trial assessed whether once-weekly sirolimus (rapamycin) 6 mg enhances or inhibits functional gains from a home-based exercise programme.
recorded 2026-08-30 · last checked 2026-09-04
Q17
What is recorded about Sirolimus and mTOR?
"Pharmacological strategies targeting SIRT1 activation and mTOR inhibition, such as NAD + boosters and rapamycin analogs, show promise in preclinical models but require further clinical validation." — where Sirolimus and mTOR appear together. Europe PMC · pathway abstract search · 2026-07-22
"Pharmacological strategies targeting SIRT1 activation and mTOR inhibition, such as NAD + boosters and rapamycin analogs, show promise in preclinical models but require further clinical validation."
sirtuinPMID 41165878
"Pharmacological strategies targeting SIRT1 activation and mTOR inhibition, such as NAD + boosters and rapamycin analogs, show promise in preclinical models but require further clinical validation."
NAD+PMID 41165878
"Pharmacological strategies targeting SIRT1 activation and mTOR inhibition, such as NAD + boosters and rapamycin analogs, show promise in preclinical models but require further clinical validation."
senolyticPMID 42534639
"Comparative consideration is also given to established aging-relevant candidates, including metformin, rapamycin, resveratrol, GLP-1 receptor agonists, NAD<sup>+</sup> modulators, and senolytic strategies, in order to contextualize the potential relevance and limitations of metabolic-vascular pathway modulation in aging research."
NAD+PMID 42534639
"Comparative consideration is also given to established aging-relevant candidates, including metformin, rapamycin, resveratrol, GLP-1 receptor agonists, NAD<sup>+</sup> modulators, and senolytic strategies, in order to contextualize the potential relevance and limitations of metabolic-vascular pathway modulation in aging research."
mTOR
PMID 42229735
"The effects of modulating ACE2 and mTOR signaling were investigated using the agonist Diminazene Aceturate (DIZE), inhibitor MLN-4760, activator MHY1485 (MHY), and inhibitor Rapamycin (Rapa)."
PMID 42229735
"Mechanistically, the cardioprotective effects of DIZE were mimicked by mTOR activation and, importantly, abolished by mTOR inhibition with Rapamycin."
autophagyPMID 42486454
"Compound C alone mimicked YSTLF's effects without additivity, whereas rapamycin aggravated GTW-induced viability loss, apoptosis, and autophagy/apoptosis co-activation."
AMPKPMID 42462870
"In a TCE-sensitized mouse model, we demonstrated that TCE sensitization inhibited LKB1/AMPK/mTOR signaling pathway (LKB1 overexpression, AICAR, rapamycin) or autophagy (3-MA) in hepatocytes, resulting in defective mitophagy."
autophagyPMID 42462870
"In a TCE-sensitized mouse model, we demonstrated that TCE sensitization inhibited LKB1/AMPK/mTOR signaling pathway (LKB1 overexpression, AICAR, rapamycin) or autophagy (3-MA) in hepatocytes, resulting in defective mitophagy."
sirtuinPMID 42157427
"In conclusion, these results indicated that FGF21 could restore ASC viability by upregulating TFE3-mediated autophagy flux in part through the FGFR1-SIRT1-MTOR signaling pathway, enhanced the potential to improve the differentiation of ASCs into neural stem cells and enhanced the therapeutic effect of ASCs transplantation in acute ICH.<b>Abbreviations</b>: FGF21: fibroblast growth factor 21;…"
autophagyPMID 42157427
"In conclusion, these results indicated that FGF21 could restore ASC viability by upregulating TFE3-mediated autophagy flux in part through the FGFR1-SIRT1-MTOR signaling pathway, enhanced the potential to improve the differentiation of ASCs into neural stem cells and enhanced the therapeutic effect of ASCs transplantation in acute ICH.<b>Abbreviations</b>: FGF21: fibroblast growth factor 21;…"
AMPKPMID 42380169
"These partial reversal of senescence-associated features by rapamycin and NAM were associated with altered AMPK, mTORC1 and mTORC2 activity, and autophagy modulation."
recorded 2026-07-22 · last checked 2026-09-04
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