This page shows what was measured, who it was measured in, and what that does not settle.
What Everolimus does in the body
Functional carcinoid tumors
From the FDA-approved label: Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in several human cancers and in tuberous sclerosis complex (TSC). Everolimus binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation with mTOR complex 1 (mTORC1) and thus inhibition of mTOR kinase activity. Everolimus reduced the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic initiation factor 4E-binding protein (4E-BP1), downstream effectors of mTOR, involved in protein synthesis.
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 · 9HW64Q8G6G · read 2026-08-29
Its recorded molecular formula is C53H83NO14, weighing 958.25 g/mol.
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. 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 104 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 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
Major Adverse Cardiac Events (MACE)
✗ The study did not show it
Who was studied
NCT03048825
How many people
7264
Study design
Phase 3
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
Major bleeding
✗ The study did not show it
Who was studied
NCT04609111
How many people
6002
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
Target lesion failure (TLF)
✗ The study did not show it
Who was studied
NCT01267734
How many people
3750
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
Ischemia Driven Target Lesion Failure (TLF)
✗ The study did not show it
Who was studied
NCT00307047
How many people
3687
Study design
Phase 3
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
Target Lesion Failure(TLF)
✗ The study did not show it
Who was studied
NCT03185221
How many people
3660
Study design
Phase 3
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.6 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.1 registered measure of this kind.
■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 C. elegans (roundworm), Mouse, Rat. 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.
cockcroft gault calculated creatinine clearance
Meaningful
Things that change how a life goes, not only a number.
progression free survival
progression free survival rate at 24 weeks
overall survival at 12 months
disease free survival
progression free survival at 6 months
overall survival
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 (33)
maximum tolerated dose
overall objective response
clinical benefit rate
renal function at month 12 post transplantation
renal function assessed by measured gfr
composite efficacy endpoints 12 month analysis
composite efficacy failure at 12 months
safety and tolerability
clinical benefit response rate
renal function
calculated glomerular filtration rate
maximum tolerated dose in phase i
overall response rate of treated at mtd/phase ii dose level
response rate
calculated gfr
phase ii overall response rate
objective response
free of dose limiting toxicity
reporting a dose limiting toxicity
confirmed tumor responses
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.
Yulithira tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
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: “The safe and effective use of everolimus in kidney or liver transplant patients younger than 18 years of age has not been established.”
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
On older people, the label states: “There is limited clinical experience on the use of everolimus in patients of age 65 years or older.”
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on animal studies and the mechanism of action [ See Clinical Pharmacology ( 12.1 ) ], Everolimus can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Contraception Females should not be pregnant or become pregnant while receiving everolimus.”
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
On people with reduced liver function, the label states: “Everolimus whole blood trough concentrations should be closely monitored in patients with impaired hepatic function.”
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is needed in patients with renal impairment. [ See Clinical Pharmacology ( 12.6 ) ]”
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · 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, tablet, for suspension, given by the oral 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.
Everolimus appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10411 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
112 products list this as an active ingredient in the United States drug directory. 112 of them contain it and nothing else.
FDA National Drug Code directory · 82293-032 · read 2026-08-29
They are sold as powder, tablet and tablet, for suspension, taken oral.
FDA National Drug Code directory · 82293-032 · read 2026-08-29
The regulator's established pharmacologic class for it is cytochrome p450 2d6 inhibitors [moa], cytochrome p450 3a4 inhibitors [moa] and decreased immunologic activity [pe].
FDA National Drug Code directory · 82293-032 · read 2026-08-29
20 published labels name it as an active ingredient. 20 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 5e325efa-8ae6-4dac-b59b-d7c74c73186c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 5e325efa-8ae6-4dac-b59b-d7c74c73186c · read 2026-08-29
Everolimus is oral at 3 DOSAGE FORMS AND STRENGTHS Everolimus tablets are available as 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg tablets., recorded as fda label in effect 2025-01-13 in the United States.
US prescribing information · 59cb86d5-8706-4619-b074-af253d3e0b68 · read 2026-08-30
Recorded price in US: 1.97619–26.32425 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 57 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 Everolimus 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 Everolimus 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
20 documents were read for this substance.
RNAWiki source record
12 of them state the same halfLife, and they agree.
RNAWiki source record
20 of them state the same proteinBinding, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
9HW64Q8G6G
RxNorm concept
845507
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, S3, S4, 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
22 approved applications cover products containing this substance. The earliest was NDA022334, approved 20090330 to NOVARTIS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 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.
What was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
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.
Claims that go past the evidence — 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.
Recorded evidence blocks (13)
Q2
What did Everolimus's largest trial (1939 people) and its longest (18 years) measure?
1939 people in Everolimus's largest registered study, 18 years in its longest registered window, measuring Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation. ClinicalTrials.gov · 2026-09-01
374 phase2, 218 phase1, 96 phase3, 82 phase4, 17 na, 13 na or unstated, 9 early phase1; NCT05725200; 2040-12-31. Last human test completed 2026, NCT05188118.
Interpretation These counts include studies where Everolimus 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.
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phase2
374
phase1
218
phase3
96
phase4
82
na
17
na or unstated
13
2 more recorded rows
early phase1
9
Last recorded human testNCT05188118
2026-06-05
recorded 2026-09-01 · last checked 2026-09-04
Q3
From C. elegans to human: where has Everolimus shown lifespan?
Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from… — the recorded outcome words.
Show the evidence
C. elegans
lifespan
mouse
lifespan
rat
mechanism-only
humanNCT00402532
lifespan; Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation; 704
15 recorded entries; human; also "Everolimus 10 mg", "Everolimus 10mg daily", "concurrent RAD001 10 mg/day"
Show the evidence
human
NCT00363051
Everolimus 10 mg
NCT01051791
Everolimus 10mg daily
NCT01062399
concurrent RAD001 10 mg/day
NCT01062399
concurrent RAD001 2.5 mg/day
NCT01062399
concurrent RAD001 5 mg/day
NCT01062399
post-radiation RAD001 10 mg/day
9 more recorded rows
humanNCT01514110
RAD001 with Paclitaxel 175 mg/m2 and carboplatin (AUC=5) on Day 1, every 3 weeks until PD
humanNCT02029001
Everolimus (10 mg QD)
humanNCT02305810
Everolimus 10 mg daily
humanNCT02968927
Everolimus 0.5 MG
humanNCT03174171
Everolimus 0.75 mg
humanNCT06472388
Everolimus 5 MG
humanNCT06727305
Everolimus 0.5 MG Oral Tablet
humanNCT06727305
Everolimus 1 MG Oral Tablet
humanNCT06727305
Everolimus 2 MG Oral Tablet
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of biochemical response rate, calculated gfr and calculated glomerular filtration rate did Everolimus's trials measure?
biochemical response rate, calculated gfr and calculated glomerular filtration rate lead 40 outcome terms across Everolimus's trials. ClinicalTrials.gov · 2026-09-01
progression free survival, renal function at month 12 post transplantation, renal function assessed by measured gfr, composite efficacy endpoints 12 month analysis, cockcroft gault calculated creatinine clearance and composite efficacy failure at 12 months follow.
Show the evidence
maximum tolerated dose
1
overall objective response
1
clinical benefit rate
1
progression free survival
1
renal function at month 12 post transplantation
1
renal function assessed by measured gfr
1
14 more recorded rows
composite efficacy endpoints 12 month analysis
1
cockcroft gault calculated creatinine clearance
1
composite efficacy failure at 12 months
1
safety and tolerability
1
clinical benefit response rate
1
renal function
1
calculated glomerular filtration rate
1
maximum tolerated dose in phase i
1
overall response rate of treated at mtd/phase ii dose level
1
response rate
1
calculated gfr
1
phase ii overall response rate
1
objective response
1
free of dose limiting toxicity
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Everolimus's 87 ongoing trials reports first?
To identify the maximum tolerated dose of RAD001 that can be given in combination with twice daily PKC412 in patients who are non-chemotherapy candidates with AML or MDS.; Number of Participants With Objective Response Rate; latest 2040-12-31
Show the evidence
Trial
NCT00819546
"RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS"; n 29; "To identify the maximum tolerated dose of RAD001 that can be given in combination with twice daily PKC412 in patients who are non-chemotherapy candidates with AML or MDS."; 2026-12
NCT01068249
"Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer"; n 42; "Number of Participants With Objective Response Rate"; 2028-04-30
NCT01087554
"Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer"; n 249; "Maximum Tolerated Dose (MTD)"; 2026-08-18
NCT01217931
"Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial"; n 180; "Time to Overall Treatment Failure"; 2028-01-31
NCT01674140
"S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer"; n 1939; "Invasive Disease-Free Survival (IDFS)"; 2030-01
NCT01805271
"Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy"; n 1278; "To evaluate the benefit from adding everolimus to standard endocrine treatments after two years of treatment on the disease-free survival (DFS)"; 2030-06
14 further recorded trials
NCT02029001
"Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment"; n 900; "Induction Progression-Free Rate after induction treatment"; 2028-10
NCT02057133
"A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread"; n 198; "Number of Participants with One or More Drug-Related Adverse Events"; 2026-12
NCT02081755
"Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer"; n 336; "Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first."; 2027-03
NCT02143726
"Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer"; n 35; "Progression Free Survival"; 2028-08-06
NCT02321501
"Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer"; n 37; "Maximum tolerated dose (MTD) of ceritinib and everolimus, defined as the highest dose level in which 6 patients were treated with at most 1 experiencing a dose limiting toxicity"; 2026-12-31
NCT02397083
"Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer"; n 102; "Response rate (levonorgestrel intrauterine device [LIUD] alone)"; 2026-09-30
NCT02432560
"Safety and Durability of Sirolimus for Treatment of LAM"; n 600; "Long term safety of mTOR inhibitor treatment in LAM"; 2025-07-31
NCT02811861
"Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma"; n 1069; "Progression-free Survival (PFS) by Independent Imaging Review (IIR)"; 2027-03-31
NCT02813135
"European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors"; n 472; "Recommended phase II dose (RP2D)"; 2031-02
NCT02962414
"Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment"; n 206; "Occurances of adverse events and serious adverse events"; 2026-12-30
NCT03008408
"A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma"; n 90; "Clinical benefit rate (CBR)"; 2028-08-31
NCT03032406
"CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer"; n 53; "Feasibility: Number of Participants Who Completed 6 Cycles of Protocol Treatment Without Grade 3 or 4 Toxicity"; 2027-01-01
NCT03049189
"Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients"; n 324; "Progression-Free Survival (PFS)"; 2029-11
NCT03114527
"Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)"; n 48; "Antitumor activity of Ribociclib in combination with Everolimus in advanced LMS or DDL"; 2026-12
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Everolimus could settle lifespan?
NCT04195750 measures Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), reading out 2026-09-17.
26 open trials; n 755; "A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)"
Show the evidence
Trial
NCT04195750
"A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)"; n 755; "Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)"; 2026-09-17
NCT05306340
"A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)"; n 373; "Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population"; 2026-10-15
NCT06472388
"Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors"; n 100; "Progression free survival rate at 12 months"; 2026-12-31
NCT02081755
"Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer"; n 336; "Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first."; 2027-03
NCT02811861
"Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma"; n 1069; "Progression-free Survival (PFS) by Independent Imaging Review (IIR)"; 2027-03-31
NCT04665739
"Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors"; n 70; "Median progression-free survival (PFS)"; 2027-07-01
14 further recorded trials
NCT05983107
"Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer"; n 102; "First stage progression free survival (PFS1)"; 2027-07-15
NCT04919226
"Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE"; n 259; "Progression-Free Survival"; 2027-09
NCT05012371
"Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer"; n 90; "Progression-Free Survival (PFS)"; 2027-10-25
NCT07024173
"A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer"; n 240; "Progression free survival (PFS) evaluated by the blinded independent central review (BICR)."; 2027-12
NCT05949541
"Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer"; n 265; "Progression Free Survival (PFS)"; 2028-01
NCT06105632
"A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment"; n 333; "Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"; 2028-01-21
NCT02143726
"Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer"; n 35; "Progression Free Survival"; 2028-08-06
NCT06680921
"A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)"; n 482; "Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1"; 2028-08-31
NCT06326190
"177Lu-DOTATATE for Recurrent Meningioma"; n 136; "Progression Free Survival (PFS)"; 2028-12-22
NCT06428396
"Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)"; n 120; "Progression-free Survival (PFS)"; 2028-12-25
NCT05773274
"Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial"; n 100; "Progression-free survival (PFS)"; 2029-04-30
NCT06943755
"Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors"; n 440; "Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)"; 2029-06-30
NCT05826964
"Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer"; n 24; "Progression-Free Survival 1 (PFS1) Among Participants in Step 2"; 2029-07-31
NCT05918302
"Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus."; n 170; "Progression-free survival (PFS)"; 2029-10
Q9
Which 173 trials of Everolimus posted no result?
Posted no result
173 of 173 completed trials
Registrations
NCT00443937, NCT00107237, NCT00093639, NCT00286624, NCT00081874 and NCT00223054, and 167 more
Completion dates
oldest 2006-03; newest 2024-08-28
Show the evidence
Trial
NCT00443937
2006-03
NCT00107237
2006-06
NCT00093639
2006-08
NCT00286624
2006-08
NCT00081874
2006-09
NCT00223054
2006-10
14 further recorded trials
NCT00170859
2006-12
NCT00098007
2007-01-08
NCT00098241
2007-03
NCT00337545
2007-04
NCT00170885
2007-07
NCT00618345
2008-08
NCT00187174
2008-10
NCT00446368
2008-10
NCT00574366
2009-02
NCT00448149
2009-06
NCT00457119
2009-11
NCT00729638
2009-11
NCT00098553
2010-02
NCT00703807
2010-05
Q10
At the median, Everolimus's trials enrolled 45 people — anything larger?
Median enrolment
45
Largest enrolment
1939
Registered trials counted
694
Q11
What do 10411 spontaneous reports say about Everolimus — 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.
Everolimus appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10411 reaction mentions were counted: diarrhoea 1838; stomatitis 1530; malignant neoplasm progression 1440; pyrexia 1389. open-targets-adr · CHEMBL1908360 · 2026-06-24
Show the evidence
diarrhoea
1838
stomatitis
1530
malignant neoplasm progression
1440
pyrexia
1389
cough
977
decreased appetite
884
4 more recorded rows
pneumonitis
657
disease progression
602
blood creatinine increased
586
interstitial lung disease
508
recorded 2026-06-24 · last checked 2026-09-04
Q12
Everolimus and CYP3A4 and P-GP: shared by which compounds?
CYP3A4 and P-GP appear in Everolimus's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30
Drug interaction studies have not been conducted with drugs other than those described below. [ See Warnings and Precautions ( 5.14 ), and Drug Interactions ( 7 ) ] Cyclosporine (CYP3A4/P-gp Inhibitor and CYP3A4 Substrate ): Everolimus should be taken concomitantly with cyclosporine in kidney transplant patients.
clinical_pharmacology
Ketoconazole and Other Strong CYP3A4 Inhibitor s: Multiple-dose administration of 200 mg ketoconazole twice daily for 5 days to 12 healthy volunteers significantly increased everolimus C max , AUC, and half-life by 3.9-fold, 15-fold, and 89%, respectively, when coadministered with 2 mg everolimus.
pharmacokinetics
Elimination Metabolism Everolimus is a substrate of CYP3A4 and P-gp.
clinical_pharmacology
Results indicate the half-life of everolimus in maintenance renal transplant patients receiving single doses of 0.75 mg or 2.5 mg everolimus during steady-state cyclosporine treatment was 30 ± 11 hours (range: 19 to 53 hours). 12.5 Drug-Drug Interactions Everolimus is known to be a substrate for both cytochrome CYP3A4 and P-gp.
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Everolimus studied with exercise?
exercise is named in Everolimus's label sentences: "Invasive haemodynamic profiles at rest and during exercise after heart transplantation (HTx) have never been described in a randomized trial where de novo everolimus (EVR)-based therapy with early calcineurin inhibitor (CNI) withdrawal has been compared with conventional CNI treatment." openfda-label+europepmc · 2026-08-30
1 recorded statement; exercise
Show the evidence
exercise
Invasive haemodynamic profiles at rest and during exercise after heart transplantation (HTx) have never been described in a randomized trial where de novo everolimus (EVR)-based therapy with early calcineurin inhibitor (CNI) withdrawal has been compared with conventional CNI treatment.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Everolimus and mTOR?
"The mTOR inhibitor everolimus (RAD001), previously used in first-line treatment of metastatic renal cancer (mRCC), is currently reserved for the following lines of therapy." — where Everolimus and mTOR appear together. Europe PMC · pathway abstract search · 2026-08-08
"The mTOR inhibitor everolimus (RAD001), previously used in first-line treatment of metastatic renal cancer (mRCC), is currently reserved for the following lines of therapy."
PMID 42479152
"This review article summarizes and shows the effectiveness and potential of repurposed drugs including metabolic and cardiovascular modulators (metformin, simvastatin), antimicrobial and antiparasitic agents (artesunate, ivermectin, ketoconazole, chloroquine, hydroxychloroquine, niclosamide, doxycycline, pentamidine), mTOR inhibitors (temsirolimus, everolimus, rapamycin), anti-inflammatory and…"
PMID 42570420
"We evaluated the effects of mTOR inhibitor everolimus in tumor microenvironment (TME) changes, including immune cell infiltration, immune checkpoint expression, and key pathways associated with immune suppression and angiogenesis, to define the mechanisms underlying TME remodeling."
NAD+PMID 40330142
"Previous studies suggest that targeting the aberrant expression of mTOR regulators p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyl transferase (NAMPT) sensitizes pNENs to everolimus."
autophagy
PMID 40355936
"In conclusion, melatonin is thought to improve the effectiveness of everolimus by inhibiting mTOR downstream effectors, enhancing apoptosis, activating autophagy, improving mitochondrial respiration, and reducing MCF-7 growth."
PMID 37932653
"The outcomes from the mechanistic studies infer that the combination of MTI-31 and RAD001 increases the LC3 levels, which in turn translates into the activation of autophagy."
PMID 37932653
"To conclude, the combination of MTI-31 and RAD001 improves the anti-cancerous impact produced by RAD001 in vivo through the promotion of autophagy."
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