This page shows what was measured, who it was measured in, and what that does not settle.
What Lenvatinib does in the body
Locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer
From the FDA-approved label: Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; platelet derived growth factor receptor alpha (PDGFRA), KIT, and RET.
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 · EE083865G2 · read 2026-08-29
Its recorded molecular formula is C21H19ClN4O4•CH4O3S, weighing 522.96.
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · 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 95 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.
Overall Survival (OS)
✗ The study did not show it
Who was studied
NCT03486873
How many people
3500
Study design
Phase 3
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
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
✗ The study did not show it
Who was studied
NCT04736706
How many people
1854
Study design
Phase 3
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
Percentage of patients that are treated based on their molecular tumor profile
✗ The study did not show it
Who was studied
NCT02925234
How many people
1550
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
Overall Survival (OS).
✗ The study did not show it
Who was studied
NCT06364631
How many people
1250
Study design
Phase 3
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
Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA)
✗ The study did not show it
Who was studied
NCT02861573
How many people
1200
Study design
Phase 1/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
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
✗ The study did not show it
Who was studied
NCT02811861
How many people
1069
Study design
Phase 3
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
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.5 registered measures of this kind. 4 written-up studies 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.5 registered measures 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 Mouse. 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.
time to maximum plasma concentration
maximum observed concentration
time at which the highest drug concentration occurs
maximum observed concentration at steady state
minimum observed concentration at steady state
Meaningful
Things that change how a life goes, not only a number.
phase 2 progression free survival
progression free survival rate at month 6
progression free survival
overall survival
disease free 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 (30)
maximum tolerated dose
objective response rate
dose limiting toxicity
adverse events/serious adverse events
phase 1b number of dose limiting toxicity
phase 1b maximum tolerated dose and recommended phase 2 dose
adverse events
treatment emergent adverse events
treatment emergent adverse events and serious adverse events
who experienced a dose limiting toxicity
who experienced an adverse event
who discontinued study treatment due to an ae
best overall response rate
apparent clearance
apparent volume of distribution
objective response rates
a decrease of 50 in prostatic specific antigen
discontinuing study drug due to aes
that are treated based on their molecular tumor profile
objective tumor response
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 28 hours hours
Read from the label, which states: “Elimination The terminal elimination half-life of lenvatinib was approximately 28 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
LENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). ( 1.1 ) Renal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC).
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 safety and effectiveness of LENVIMA in pediatric patients have not been established.”
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-30
On older people, the label states: “Of the 261 patients with differentiated thyroid cancer (DTC) who received LENVIMA in SELECT, 45% were ≥65 years of age and 11% were ≥75 years of age.”
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and its mechanism of action, LENVIMA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] .”
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary It is not known whether LENVIMA is present in human milk; however, lenvatinib and its metabolites are excreted in rat milk at concentrations higher than those in maternal plasma ( see Data ) .”
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustment is recommended for patients with HCC and mild hepatic impairment (Child-Pugh A).”
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment is recommended for patients with mild (CLcr 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment.”
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · 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.
No source is stored against this line.
What is in the pack
Sold as capsule, 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.
Lenvatinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4409 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
19 products list this as an active ingredient in the United States drug directory. 19 of them contain it and nothing else.
FDA National Drug Code directory · 54893-0080 · read 2026-08-29
They are sold as capsule and powder, taken oral.
FDA National Drug Code directory · 54893-0080 · read 2026-08-29
The regulator's established pharmacologic class for it is kinase inhibitor [epc] and receptor tyrosine kinase inhibitors [moa].
FDA National Drug Code directory · 54893-0080 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-29
Lenvima is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 4 mg: yellowish-red body and yellowish-red cap, marked in black ink with “Є” on cap and “LENV 4 mg” on body. 10 mg: yellow body and yellowish-red cap, marked in black ink with “Є”…, recorded as fda label in effect 2026-06-30 in the United States.
US prescribing information · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · read 2026-08-30
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 Lenvatinib 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 Lenvatinib 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.
Where else this substance is registered
FDA substance identifier (UNII)
EE083865G2
RxNorm concept
1604345
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.
✓ 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
2 approved applications cover products containing this substance. The earliest was NDA206947, approved 20150213 to EISAI INC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
6 questions this page could not answer
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Recorded evidence blocks (13)
Q2
What did Lenvatinib's largest trial (3500 people) and its longest (25 years) measure?
3500 people in Lenvatinib's largest registered study, 25 years in its longest registered window, measuring Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC). ClinicalTrials.gov · 2026-09-01
257 phase2, 85 phase1, 58 phase3, 23 na, 22 na or unstated, 6 phase4, 5 early phase1; NCT03486873; 2043-08-04; no ageing endpoint recorded. Last human test completed 2026, NCT04039607.
Interpretation These counts include studies where Lenvatinib 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
257
phase1
85
phase3
58
na
23
na or unstated
22
phase4
6
2 more recorded rows
early phase1
5
Last recorded human testNCT04039607
2026-07-09
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Lenvatinib shown biomarker?
10 recorded entries; human; also "Placebos (matched to 4 mg and 10 mg lenvatinib capsules).", "Lenvatinib 24 mg", "Lenvatinib 10 mg"
Show the evidence
human
NCT01525394
Placebos (matched to 4 mg and 10 mg lenvatinib capsules).
NCT02657369
Lenvatinib 24 mg
NCT02723630
Lenvatinib 10 mg
NCT04227808
Lenvima 4 mg Oral Capsule
NCT04227808
Lenvatinib 4 mg Oral Capsule
NCT04241523
Lenvatinib 4 mg Oral
4 more recorded rows
humanNCT04241523
Lenvima 4 mg Oral
humanNCT04443322
Lenvatinib 4 MG
humanNCT04745988
Lenvatinib 20mg
humanNCT04745988
Lenvatinib 8mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Lenvatinib's half-life is 28 hours — which schedules were studied?
28 hours, the half-life Lenvatinib's label states. openfda-label · f4bedd21-efde-44c6-9d9c-b48b78d7ed1e · 2026-08-30
Show the evidence
half life
28 hours hours; Elimination The terminal elimination half-life of lenvatinib was approximately 28 hours.
metabolism
Metabolism The main metabolic pathways for lenvatinib in humans were identified as enzymatic (CYP3A and aldehyde oxidase) and non-enzymatic processes.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of a decrease of 50 in prostatic specific antigen, adverse events and adverse events/serious adverse events did Lenvatinib's trials measure?
a decrease of 50 in prostatic specific antigen, adverse events and adverse events/serious adverse events lead 40 outcome terms across Lenvatinib's trials. ClinicalTrials.gov · 2026-09-01
adverse events/serious adverse events, phase 1b number of dose limiting toxicity, phase 1b maximum tolerated dose and recommended phase 2 dose, phase 2 progression free survival, progression free survival rate at month 6 and adverse events follow.
Show the evidence
maximum tolerated dose
1
objective response rate
1
dose limiting toxicity
1
adverse events/serious adverse events
1
phase 1b number of dose limiting toxicity
1
phase 1b maximum tolerated dose and recommended phase 2 dose
1
14 more recorded rows
phase 2 progression free survival
1
progression free survival rate at month 6
1
adverse events
1
progression free survival
1
overall survival
1
treatment emergent adverse events
1
treatment emergent adverse events and serious adverse events
1
who experienced a dose limiting toxicity
1
who experienced an adverse event
1
who discontinued study treatment due to an ae
1
best overall response rate
1
apparent clearance
1
apparent volume of distribution
1
time to maximum plasma concentration
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Lenvatinib's 173 ongoing trials reports first?
best overall response rate (BOR); Progression-free Survival (PFS) by Independent Imaging Review (IIR); latest 2043-08-04
Show the evidence
Trial
NCT02780310
"Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma"; n 33; "best overall response rate (BOR)"; 2027-05
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
NCT02861573
"Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)"; n 1200; "Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA)"; 2028-07-24
NCT02925234
"The Drug Rediscovery Protocol (DRUP Trial)"; n 1550; "Percentage of patients that are treated based on their molecular tumor profile"; 2027-12
NCT03313206
"Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma"; n 60; "Disease Free Survival"; 2029-01
NCT03486873
"Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)"; n 3500; "Overall Survival (OS)"; 2043-08-04
14 further recorded trials
NCT03899428
"Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC"; n 30; "Time to decline to ≥ 2 log10 IU/mL of serum HBsAg"; 2025-12-31
NCT03950609
"Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors"; n 36; "Radiographic response rate"; 2028-03-30
NCT04008797
"A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor"; n 301; "Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)"; 2027-03-31
NCT04171622
"Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer"; n 25; "Overall survival"; 2027-08-31
NCT04207086
"A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma"; n 21; "Pathological response rate"; 2033-01-01
NCT04209660
"Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers"; n 64; "best overall response rate"; 2026-12
NCT04287829
"Pembrolizumab Plus Lenvatinib In Second Line and Third Line Malignant Pleural mesotheLioma Patients"; n 58; "Objective response rate defined by Modified RECIST 1.1 criteria for pleural mesothelioma"; 2026-03-05
NCT04300556
"A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types"; n 182; "Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin"; 2030-08-08
NCT04393350
"Perioperative Lenvatinib With Pembrolizumab in Patients With Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma"; n 18; "Objective Response Rate (Complete and Partial Responses)"; 2026-12-11
NCT04427293
"Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)"; n 12; "Evaluate the effectiveness of preoperative anti-vascular endothelial growth factor receptor (VEGFR) therapy and immune checkpoint blockade on infiltration of CD8+ tumor infiltrating lymphocytes (TILs) (CD45RA-/CD8+/FoxP3-) in primary…"; 2027-07
NCT04519151
"Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer"; n 24; "PFS of patients treated with pembrolizumab in combination with lenvatinib."; 2029-11
NCT04522323
"A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma"; n 67; "Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs)"; 2025-09-26
NCT04586231
"A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)"; n 747; "Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)"; 2027-02-11
NCT04626479
"Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)"; n 400; "Safety Lead-in Phase: Number of participants who experience one or more dose-limiting toxicities (DLTs)"; 2026-08-21
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Lenvatinib could settle lifespan?
NCT05319431 measures Progression-free survival (PFS), reading out 2025-06-30.
60 open trials; n 60; "A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC"
Show the evidence
Trial
NCT05319431
"A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC"; n 60; "Progression-free survival (PFS)"; 2025-06-30
NCT06333561
"HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma"; n 300; "Overall survival"; 2025-12-30
NCT06371157
"A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma"; n 469; "Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)"; 2026-05-23
NCT06740370
"TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma"; n 32; "Progression-Free-Survival (PFS)"; 2026-08-30
NCT04770896
"A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab"; n 557; "Overall Survival (OS)"; 2026-10-14
NCT06089382
"A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection"; n 104; "Recurrence-Free Survival (RFS)"; 2026-11-01
14 further recorded trials
NCT04887805
"Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer"; n 28; "Progression free survival"; 2026-11-05
NCT06327269
"Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma"; n 40; "Recurrence-free survival with adjuvant therapy"; 2026-12
NCT05608213
"Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC"; n 187; "Overall survival (OS)"; 2026-12-01
NCT06201065
"FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial"; n 200; "Overall Survival (OS)"; 2026-12-26
NCT05078931
"A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients"; n 35; "Progression-free survival"; 2026-12-30
NCT05168163
"Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer"; n 122; "Overall survival (OS)"; 2026-12-31
NCT05617859
"Lenvatinib for Advanced Bone and Soft Tissue Sarcoma"; n 60; "Progression-free survival"; 2026-12-31
NCT06463548
"Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma"; n 30; "Progression-free survival (PFS)"; 2026-12-31
NCT05433116
"Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC"; n 50; "Event-free survival (EFS) rate"; 2027-01
NCT05718232
"SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)"; n 136; "Overall Survival (OS)"; 2027-02
NCT04586231
"A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)"; n 747; "Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)"; 2027-02-11
NCT05301842
"Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC"; n 760; "Progression Free Survival (PFS) for Arm A vs Arm C"; 2027-02-26
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
NCT04848337
"Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer"; n 45; "Radiologic Progression Free Survival (rPFS)"; 2027-04
Q10
Which 35 trials of Lenvatinib posted no result?
Posted no result
35 of 35 completed trials
Registrations
NCT02198170, NCT02199392, NCT02421042, NCT02199379, NCT00121680 and NCT02430714, and 29 more
Completion dates
oldest 2011-06; newest 2024-08-28
Show the evidence
Trial
NCT02198170
2011-06
NCT02199392
2012-01
NCT02421042
2012-07
NCT02199379
2012-10
NCT00121680
2015-05
NCT02430714
2016-11-06
14 further recorded trials
NCT02860936
2019-06
NCT03663114
2020-02-20
NCT02726503
2020-03-20
NCT04415567
2020-03-31
NCT02935309
2020-05-14
NCT02953743
2020-12-28
NCT04656249
2021-05-01
NCT03895970
2021-08-01
NCT03009292
2021-08-27
NCT02966093
2021-12-29
NCT04008082
2022-01-28
NCT04044313
2022-02-28
NCT02788708
2022-03-31
NCT05307926
2022-08-20
Q11
At the median, Lenvatinib's trials enrolled 56 people — anything larger?
Median enrolment
56
Largest enrolment
3500
Registered trials counted
405
Q12
What do 4409 spontaneous reports say about Lenvatinib — 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.
Lenvatinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4409 reaction mentions were counted: diarrhoea 811; hypertension 743; decreased appetite 718; fatigue 577. open-targets-adr · CHEMBL1289601 · 2026-06-24
Show the evidence
diarrhoea
811
hypertension
743
decreased appetite
718
fatigue
577
proteinuria
313
palmar-plantar erythrodysaesthesia syndrome
293
4 more recorded rows
hepatic encephalopathy
269
blood pressure increased
241
hypothyroidism
225
weight decreased
219
recorded 2026-06-24 · last checked 2026-09-04
Q13
Lenvatinib and P-GP, BCRP and BSEP: shared by which compounds?
P-GP, BCRP and BSEP appear in Lenvatinib's recorded interaction sentences, 14 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A1pharmacokinetics
Lenvatinib induces CYP3A, but it does not induce CYP1A1, CYP1A2, CYP2B6, and CYP2C9.
CYP1A2
pharmacokinetics
In Vitro Studies with Substrates of CYP or UDP-glucuronosyltransferase (UGT) : Lenvatinib inhibits CYP2C8, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
pharmacokinetics
Lenvatinib induces CYP3A, but it does not induce CYP1A1, CYP1A2, CYP2B6, and CYP2C9.
CYP2A6pharmacokinetics
Lenvatinib does not inhibit CYP2A6 and CYP2E1.
CYP2B6
pharmacokinetics
In Vitro Studies with Substrates of CYP or UDP-glucuronosyltransferase (UGT) : Lenvatinib inhibits CYP2C8, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
pharmacokinetics
Lenvatinib induces CYP3A, but it does not induce CYP1A1, CYP1A2, CYP2B6, and CYP2C9.
CYP2C19pharmacokinetics
In Vitro Studies with Substrates of CYP or UDP-glucuronosyltransferase (UGT) : Lenvatinib inhibits CYP2C8, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
CYP2C8
pharmacokinetics
In Vitro Studies with Substrates of CYP or UDP-glucuronosyltransferase (UGT) : Lenvatinib inhibits CYP2C8, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
pharmacokinetics
Effect of L envatinib on O ther D rugs CYP2C8 Substrate : There is no projected significant drug-drug interaction risk between lenvatinib and repaglinide.
CYP2C9
pharmacokinetics
In Vitro Studies with Substrates of CYP or UDP-glucuronosyltransferase (UGT) : Lenvatinib inhibits CYP2C8, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
pharmacokinetics
Lenvatinib induces CYP3A, but it does not induce CYP1A1, CYP1A2, CYP2B6, and CYP2C9.
CYP2D6pharmacokinetics
In Vitro Studies with Substrates of CYP or UDP-glucuronosyltransferase (UGT) : Lenvatinib inhibits CYP2C8, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
CYP2E1pharmacokinetics
Lenvatinib does not inhibit CYP2A6 and CYP2E1.
CYP3A4pharmacokinetics
CYP3A4 Substrate : Co-administration of lenvatinib with midazolam had no effect on the pharmacokinetics of midazolam.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Lenvatinib and autophagy?
"Although TFEB overexpression conferred resistance to lenvatinib and activated autophagy, these effects were reversed by co-treatment with bikinin, which restored lenvatinib sensitivity and inhibited autophagic flux." — where Lenvatinib and autophagy appear together. Europe PMC · pathway abstract search · 2026-07-18
"Although TFEB overexpression conferred resistance to lenvatinib and activated autophagy, these effects were reversed by co-treatment with bikinin, which restored lenvatinib sensitivity and inhibited autophagic flux."
PMID 42469533
"Our work unveils a novel therapeutic axis wherein targeting eIF5A2 hypusination disrupts TFEB-dependent autophagy to overcome lenvatinib resistance in HCC cells."
mTORPMID 41991906
"Moreover, inhibition of mTOR signaling using rapamycin impeded lung metastasis and restored the sensitivity to lenvatinib."
AMPKPMID 41107802
"Our study reports a novel combined therapy using phenformin and lenvatinib, which can increase the sensitivity of HCC cells to lenvatinib via AMPK-mediated PDGFRβ degradation."
mTOR
PMID 40747694
"Our study showed that HCC cells acquire resistance to lenvatinib through the activation of NCOA5, thereby stimulating the NCOA5-Protein Kinase B-mammalian target of rapamycin (AKT-mTOR) axis."
PMID 40747694
"Everolimus, an mTOR inhibitor, in combination with lenvatinib and everolimus, exerted significant synergistic effects against HCC in vivo and in vitro ."
AMPK
PMID 36823043
"Moreover, FOXA2 overexpression was found to enhance the inhibitory effect of lenvatinib on HCC cells by upregulating the adenosine monophosphate-activated protein kinase-mechanistic target of rapamycin (AMPK-mTOR) pathway."
PMID 36823043
"Conversely, inhibition of adenosine monophosphate-activated protein kinase (AMPK) or stimulation of mechanistic target of rapamycin (mTOR) attenuated the sensitization of cells overexpressing FOXA2 to lenvatinib."
autophagyPMID 36823043
"By modulating the AMPK-mTOR-autophagy signaling pathway, FOX2 significantly augmented antitumor effect of lenvatinib in HCC."
NAD+
PMID 37204655
"However, the effect of lenvatinib, a first-line treatment for unresectable hepatocellular carcinoma (HCC), on NAD<sup>+</sup> metabolism in HCC cells, and the metabolite crosstalk between HCC and immune cells after targeting NAD<sup>+</sup> metabolism of HCC cells remain unelucidated."
PMID 37204655
"Lenvatinib targeted TET2 to synthesize and increase NAD<sup>+</sup> levels, thereby inhibiting decomposition in HCC cells."
PMID 37204655
"Consequently, lenvatinib targeted NAD<sup>+</sup> metabolism and elevated HCC-derived hypoxanthine to enhance the macrophages polarization from M2 to M1."
recorded 2026-07-18 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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