This page shows what was measured, who it was measured in, and what that does not settle.
What Thalidomide does in the body
Multiple myeloma and a painful inflammatory complication of leprosy — from the drug that caused the birth-defect disaster of 1961
Thalidomide sticks to a protein called cereblon, which is part of the machinery a cell uses to tag other proteins for destruction. With thalidomide bound, that machinery destroys a different set of proteins than it normally would. In a developing embryo, the proteins it stops destroying — and the ones it starts — are needed for limbs to form, which is why limbs failed to form. In a myeloma cell, the proteins it destroys are ones the cancer depends on to survive. Same glue, different tissue, opposite consequence.
What happened in people
Over 10,000 children born with severe malformations between 1957 and 1961
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
Vargesson records a new generation of thalidomide-damaged children in Brazil, where the drug is used for leprosy — the risk-management problem is not historical
Where it acts
Bone marrow plasma cells and the tumour microenvironment; the teratogenic site is the developing limb bud
Kind of result
The kind of result is not recorded
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 · 4Z8R6ORS6L · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 119 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.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
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.
Reduction of serum or urine paraprotein by at least 25%, sustained for at least six weeks
✓ The study showed what it set out to show
Who was studied
Singhal et al. refractory myeloma phase 2 study
How many people
84
Study design
Phase 2 single-arm dose-escalation study
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Total response rate 32% (8 patients with 90% or greater reduction including 2 complete remissions); 12-month event-free survival 22% (SE 5), overall survival 58% (SE 5)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Bone marrow microvascular density did not change significantly in responders, contradicting the antiangiogenic rationale on which the trial was designed. At least a third of patients had constipation, weakness or fatigue, or somnolence.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule, once daily, usually at bedtime (50, 100, 150 and 200 mg)
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Identification of the thalidomide-binding protein and demonstration that its ubiquitin ligase activity is required for limb outgrowth and Fgf8 expression
✓ The study showed what it set out to show
Who was studied
Ito et al. target identification (Science 2010)
How many people
0
Study design
Preclinical target identification with zebrafish and chick developmental models
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Not a clinical hypothesis test; the result is affinity-bead identification of cereblon plus loss-of-function phenotypes in two vertebrate models
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. 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 capsule, once daily, usually at bedtime (50, 100, 150 and 200 mg)
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.11 registered measures of this kind. No reviewed result.
□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 lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Mouse, Rat, Dog. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Thalidomide
What a person takes: Oral capsule, once daily, usually at bedtime (50, 100, 150 and 200 mg).
The measurement behind this step
Once-daily capsule taken with water, generally at night because of sedation. Eliminated largely by spontaneous hydrolysis rather than hepatic metabolism. Available only through the THALOMID REMS restricted distribution programme, which ties dispensing to documented pregnancy testing and contraception.
Getting in
An oral capsule, dispensed only through a restricted programme
A capsule taken once daily, usually at bedtime because it is sedating. It can only be dispensed through a controlled programme with pregnancy testing.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Oral capsules in 50, 100, 150 and 200 mg strengths. Slow absorption with a terminal half-life of roughly 5 to 7 hours. Elimination is dominated by non-enzymatic hydrolysis rather than by hepatic metabolism.
The molecule exists as two mirror-image forms, and it flips between them in the bloodstream within minutes. You cannot give one form only.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Rapid spontaneous racemisation at physiological pH means the administered enantiomer is irrelevant to exposure. Passive cellular entry; the target is intracellular, in the cytoplasm and nucleus.
Binds cereblon and reprogrammes an E3 ubiquitin ligase
It glues itself into a pocket on cereblon, part of the cell's protein disposal machinery, and changes which proteins that machinery throws away.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The glutarimide ring inserts into the tri-tryptophan pocket of CRBN within the CRL4-CRBN complex with DDB1 and Cul4A. The bound drug forms a new surface that recruits neosubstrates the ligase would not otherwise engage — a molecular glue rather than an inhibitor.
The same reprogramming, two different tissues, two different results
In a myeloma cell it destroys proteins the cancer needs. In a developing limb it disrupts the signalling that makes the limb grow.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
In myeloma, ubiquitination and proteasomal degradation of the Ikaros-family transcription factors on which the malignant plasma cell depends, with downstream immunomodulatory and anti-inflammatory effects including TNF-alpha suppression. In the embryo, CRBN-dependent disruption of limb outgrowth and Fgf8 expression, demonstrated in zebrafish and chick.
Myeloma responds; embryos are catastrophically harmed
A third of patients with refractory myeloma responded. A single capsule in pregnancy can cause severe birth defects.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Measured endpoints: 32% paraprotein response rate in 84 refractory patients with 58% twelve-month overall survival; over 10,000 children malformed between 1957 and 1961; labelled minimum teratogenic exposure of one capsule; increased deep vein thrombosis and pulmonary embolism in combination with dexamethasone.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
quality of life
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
progression free survival
overall survival time
survival
progression free survival 6 months
event free survival
overall survival
complete and partial remission
overall progression free survival at 2 years
progression free survival at 6 months
6 month overall survival
and 1 more.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (28)
time to progression
safety
response
incidence of drop out or dose reduction
response rate
toxicity
time to tumor progression
clinical response
complete response rate
disease response
antitumor activity
psa response
best response
who had a prostate specific antigen response
immune response
overall responders
duration of response
objective response
therapy completion rate
objective response rate
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.
Adults with newly diagnosed multiple myeloma, in combination with dexamethasone, and patients with the cutaneous manifestations of erythema nodosum leprosum. Dispensing is restricted through the THALOMID REMS programme with mandatory pregnancy testing.
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: “Safety and effectiveness in pediatric patients below the age of 12 years have not been established.”
US prescribing information · 2eda833b-1357-4ed4-a093-194524fcb061 · read 2026-08-30
On older people, the label states: “One hundred and seventy-six (52%) of 336 patients treated with THALOMID in combination with dexamethasone were ≥65 of age while 50 (15%) were ≥75.”
US prescribing information · 2eda833b-1357-4ed4-a093-194524fcb061 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to THALOMID during pregnancy as well as female partners of male patients who are exposed to THALOMID.”
US prescribing information · 2eda833b-1357-4ed4-a093-194524fcb061 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of thalidomide in human milk, the effects of THALOMID on the breastfed child, or the effects of THALOMID on milk production.”
US prescribing information · 2eda833b-1357-4ed4-a093-194524fcb061 · read 2026-08-30
Where the result stopped carrying
Withdrawn worldwide in 1961 after independent reports from McBride in Australia and Lenz in Germany
Never approved in the United States as a sedative, which is why the American cohort of affected children was small
Fifty years elapsed between the withdrawal and the identification of the molecular target
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
Withdrawn
❝ 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 capsule, once daily, usually at bedtime (50, 100, 150 and 200 mg)
✎ 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, S5, S6, S8.
No source is stored against this line.
What is in the pack
Once-daily capsule taken with water, generally at night because of sedation. Eliminated largely by spontaneous hydrolysis rather than hepatic metabolism. Available only through the THALOMID REMS restricted distribution programme, which ties dispensing to documented pregnancy testing and contraception.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Boxed warning for embryo-fetal toxicity and venous thromboembolism. A single capsule taken during pregnancy can cause severe birth defects or embryo-fetal death; pregnancy must be excluded before treatment and prevented afterwards by two reliable methods of contraception. Dose-limiting peripheral neuropathy is common with prolonged use and may be irreversible. Sedation, constipation, fatigue and neutropenia are frequent. Deep vein thrombosis and pulmonary embolism risk is significantly increased in combination with dexamethasone.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Thalidomide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4617 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
neuropathy peripheral — 950 reaction mentions
pneumonia — 792 reaction mentions
plasma cell myeloma — 686 reaction mentions
deep vein thrombosis — 527 reaction mentions
constipation — 489 reaction mentions
disease progression — 444 reaction mentions
pulmonary embolism — 408 reaction mentions
multiple myeloma — 120 reaction mentions
blood human chorionic gonadotropin increased — 104 reaction mentions
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 capsule, once daily, usually at bedtime (50, 100, 150 and 200 mg)
✎ 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
Eliminated largely by spontaneous hydrolysis rather than hepatic metabolism. Available only through the THALOMID REMS restricted distribution programme, which ties dispensing to documented pregnancy testing and contraception.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
14 products list this as an active ingredient in the United States drug directory. 14 of them contain it and nothing else.
FDA National Drug Code directory · 43593-210 · read 2026-08-29
They are sold as capsule and powder, taken oral.
FDA National Drug Code directory · 43593-210 · read 2026-08-29
The regulator's established pharmacologic class for it is decreased immunologically active molecule activity [pe].
FDA National Drug Code directory · 43593-210 · 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 · 2eda833b-1357-4ed4-a093-194524fcb061 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 2eda833b-1357-4ed4-a093-194524fcb061 · read 2026-08-29
Thalomid is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: • 50 mg white, printed with "BMS/50 mg" on the body and a "Do Not Get Pregnant" logo on the cap. • 100 mg tan, printed with "BMS/100 mg" on the body and a "Do Not Get Pregnant" log…, recorded as fda label in effect 2023-03-24 in the United States.
US prescribing information · 2eda833b-1357-4ed4-a093-194524fcb061 · 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, withdrawn medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Thalidomide studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the antimyeloma effect is caused by inhibition of bone marrow angiogenesis — the trial that established the effect found no significant change in microvascular density in responders
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a "safe sedative" claim made without reproductive toxicology testing described the drug's safety in pregnancy
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That identifying cereblon means non-teratogenic derivatives follow — the original paper says only that it "may contribute" to that goal, and lenalidomide and pomalidomide remain teratogenic
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Thalidomide are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
Over 10,000 children born with severe malformations before withdrawal in 1961
In plain words
Thalidomide was sold as a safe sedative, including for morning sickness. More than ten thousand children were born with severe limb and organ malformations before it was taken off the market.
What was measured
Number of children born with thalidomide-associated malformations
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Marketed from 1957 and prescribed to pregnant women for nausea. Vargesson's review states the scale plainly: "over 10,000 children were born with a range of severe and debilitating malformations", making it the largest man-made medical disaster of its kind. The characteristic phenotype was phocomelia — shortened or absent long bones — accompanied by defects of the ears, eyes, heart, kidneys and gastrointestinal tract, with the malformation pattern depending sharply on the day of gestation at exposure. The drug was withdrawn in 1961 after the independent reports of McBride in Australia and Lenz in Germany. Vargesson also records that a new generation of thalidomide-damaged children has been identified in Brazil, where the drug is used for leprosy.
Written into the record, not signed off as a reviewed claim
The disaster created the regulatory system that would have prevented it
In plain words
Thalidomide was never approved in the United States, and the near miss produced the 1962 law that requires drugs to be shown effective and safe before they go on sale.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The episode is the origin of the modern pre-approval evidence requirement. Before 1962, United States law required a demonstration of safety but not of efficacy, and review timelines allowed a drug to be marketed by default if the agency did not act. The Kefauver-Harris amendments of 1962 required proof of efficacy, informed consent in clinical trials, and reporting of adverse reactions, and comparable requirements followed in Europe. Reproductive toxicology testing became a standard pre-approval requirement as a direct consequence. Kim and Scialli's review treats the two halves of the story together, and the title states the shape of the record: the tragedy of birth defects and the effective treatment of disease.
Written into the record, not signed off as a reviewed claim
Refractory myeloma: 32% paraprotein response in 84 previously treated patients
In plain words
In patients whose myeloma had come back after high-dose chemotherapy and who had no options left, a third responded to thalidomide, and two went into complete remission.
What was measured
Paraprotein reduction of at least 25% sustained six weeks, in refractory multiple myeloma
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Eighty-four previously treated patients with refractory myeloma, 76 of whom had relapsed after high-dose chemotherapy, received oral thalidomide as a single agent for a median of 80 days (range 2 to 465), starting at 200 mg daily and escalating by 200 mg every two weeks to 800 mg. Serum or urine paraprotein fell by at least 90% in eight patients (two complete remissions), at least 75% in six, at least 50% in seven and at least 25% in six — a total response rate of 32%. Responses appeared within two months in 78% of responders and were accompanied by fewer marrow plasma cells and higher haemoglobin. At twelve months, Kaplan-Meier estimates were 22% (SE 5) event-free survival and 58% (SE 5) overall survival. At least a third of patients had mild or moderate constipation, weakness or fatigue, or somnolence; severe adverse effects occurred in under 10% and haematological effects were rare.
Written into the record, not signed off as a reviewed claim
The myeloma trial was run on an antiangiogenesis hypothesis the results did not support
In plain words
Thalidomide was tried in myeloma because it was thought to starve tumours of blood vessels. It worked — but the blood vessel density in responding patients did not actually change.
What was measured
That thalidomide's antimyeloma activity is caused by inhibition of bone marrow angiogenesis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Singhal and colleagues state the rationale explicitly: increased bone marrow vascularity carries a poor prognosis in myeloma, and thalidomide has antiangiogenic properties, so they evaluated it in refractory disease. The trial then reported, in the same results section, that "the microvascular density of bone marrow did not change significantly in patients with a response." The drug worked and the stated mechanism did not account for it. The actual mechanism — cereblon-directed degradation of transcription factors the myeloma cell depends on — was not identified for another eleven years. This is a clean example of a correct clinical prediction reached from a hypothesis the trial itself failed to confirm.
Written into the record, not signed off as a reviewed claim
Cereblon identified in 2010 — half a century after the withdrawal
In plain words
The protein thalidomide binds to, and the reason it deforms limbs, was not identified until 2010. Fifty years passed between the disaster and the explanation.
What was measured
Identification of cereblon as the thalidomide-binding protein, with loss of limb outgrowth and Fgf8 expression as the functional readout
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Ito and colleagues used thalidomide-conjugated affinity beads to identify cereblon (CRBN) as a thalidomide-binding protein. CRBN forms an E3 ubiquitin ligase complex with damaged DNA binding protein 1 (DDB1) and Cul4A which is required for limb outgrowth and for expression of the fibroblast growth factor Fgf8 in zebrafish and chicks. Thalidomide initiates its teratogenic effects by binding CRBN and inhibiting the associated ubiquitin ligase activity. The paper states its own forward-looking claim carefully — that the finding "may contribute to the development of new thalidomide derivatives without teratogenic activity" — and the same target turned out to explain the antimyeloma effect, which is why the class is now described as cereblon E3 ligase modulators rather than antiangiogenics.
Written into the record, not signed off as a reviewed claim
The current label states the risk in absolute terms: one capsule
In plain words
The boxed warning does not hedge. A single capsule taken during pregnancy can cause severe birth defects, and the drug is dispensed only through a restricted programme with mandatory pregnancy testing.
What was measured
Labelled minimum teratogenic exposure and required risk-management controls
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The THALOMID boxed warning covers embryo-fetal toxicity and venous thromboembolism. On the first: "If THALOMID is taken during pregnancy, it can cause severe birth defects or embryo-fetal death... Even a single dose [1 capsule (regardless of strength)] taken by a pregnant woman during her pregnancy can cause severe birth defects. Pregnancy must be excluded before start of treatment. Prevent pregnancy thereafter by the use of two reliable methods of contraception." Distribution is restricted through the THALOMID REMS programme. On the second: significantly increased risk of deep vein thrombosis and pulmonary embolism in myeloma patients receiving thalidomide with dexamethasone, which is the reason thromboprophylaxis is standard in those regimens.
Source
THALOMID (thalidomide) US Prescribing Information, boxed warning and THALOMID REMS, NDA 020785
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Approved for leprosy in 1998 and for myeloma in 2006, by the agency that kept it out in 1961
In plain words
The FDA never let thalidomide onto the American market in the first place. Thirty-seven years later it approved the same drug, with a distribution system built around the risk.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Drugs@FDA records NDA 020785 (Celgene, now Bristol Myers Squibb) with original approval on 16 July 1998 for the cutaneous manifestations of moderate to severe erythema nodosum leprosum. A supplement approved on 25 May 2006 added multiple myeloma in combination with dexamethasone, now labelled for newly diagnosed disease. The marketing status is Prescription. The approval did not rest on the risk having been resolved — it rests on the risk being contained by a restricted distribution programme with mandatory pregnancy testing and dual contraception, in patients for whom the alternative is an incurable cancer or a disabling inflammatory complication.
Source
Drugs@FDA: THALOMID (thalidomide), NDA 020785, original approval 16 July 1998, supplement 31 approved 25 May 2006
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
4Z8R6ORS6L
RxNorm concept
200390
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Trial roles classified for highlighted evidence
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Suppression classes recorded: S1, S3, S5, S6, S8.
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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
3 approved applications cover products containing this substance. The earliest was NDA020785, approved 19980716 to BRISTOL-MYERS.
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What is not here
5 questions this page could not answer
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Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
The drug that created modern drug regulation by malforming over 10,000 children, and that in 1999 produced a 32% paraprotein response rate in 84 patients with refractory myeloma — with cereblon, identified in 2010, turning out to be the target of both effects.
Recorded evidence blocks (12)
Q2
What did Thalidomide's largest trial (1623 people) and its longest (22 years) measure?
1623 people in Thalidomide's largest registered study, 22 years in its longest registered window, measuring Overall Survival Time. ClinicalTrials.gov · 2026-09-01
213 phase2, 63 phase3, 27 phase1, 15 na, 15 phase4, 3 na or unstated, 2 early phase1; NCT00098475; 2026-10-23; no ageing endpoint recorded. Last human test completed 2026, NCT06299670.
Interpretation These counts include studies where Thalidomide 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
213
phase3
63
phase1
27
na
15
phase4
15
na or unstated
3
2 more recorded rows
early phase1
2
Last recorded human testNCT06299670
2026-01-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
From C. elegans to human: where has Thalidomide shown lifespan?
Proportion of Patients With Objective Response (First Phase, Step 1); To find out if outcomes of participants in this study will be better when compared to individuals who participated in Total Therapy II, especially those with chromosome…; latest 2030-06-30
Show the evidence
Trial
NCT00098475
"Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma"; n 452; "Proportion of Patients With Objective Response (First Phase, Step 1)"; 2026-10-23
NCT00572169
"UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy"; n 177; "To find out if outcomes of participants in this study will be better when compared to individuals who participated in Total Therapy II, especially those with chromosome abnormalities."; 2027-08
NCT00602641
"Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma"; n 306; "Progression-Free Survival (PFS)"; 2027-02-20
NCT00734877
"UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma"; n 382; "Progression-free survival rate"; 2028-09
NCT00869232
"UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission"; n 90; "Accelerate and sustain, at 2 years from starting therapy"; 2028-10
NCT00871013
"Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy"; n 160; "The primary objective of this study is to assess the continued complete and near complete response rate (CR/nCR) at two years after initiation of therapy. ."; 2027-12
14 further recorded trials
NCT01356290
"Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors"; n 232; "Efficacy"; 2030-04
NCT03004287
"2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy"; n 50; "Measure the progression-free survival in patients with high risk multiple myeloma"; 2027-10
NCT03069326
"A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis"; n 30; "best objective response rate (ORR)"; 2027-02
NCT06017284
"Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer"; n 100; "Rate of nausea/vomiting"; 2026-11-30
NCT06268093
"The Therapeutic Effect of Thalidomide in Syringomyelia"; n 30; "ASIA Score"; 2028-02
NCT06382519
"Thalidomide Therapy for VEOIBD"; n 40; "endoscopic response rate"; 2026-12-31
NCT06438679
"3T Therapy in the Treatment of MDA5-positive Dermatomyositis"; n 133; "Overall survival rate"; 2026-12
NCT06490601
"Long Term Beta Thalassemia Treatment: Findings From The Extension Period"; n 30; "hemoglobin levels"; 2025-07-01
NCT06490627
"Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia"; n 54; "transfusion dependency"; 2026-04-22
NCT06617182
"Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury."; n 150; "Treatment response rate."; 2028-11-01
NCT06772480
"Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)"; n 100; "Mean increase in hemoglobin levels from baseline"; 2026-01-31
NCT06793475
"Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple Myeloma Patients With Extramedullary Disease"; n 20; "Overall response rate (ORR)"; 2026-12
NCT07172659
"Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction"; n 45; "The proportion of dovramilast (100 mg or 150 mg) recipients achieving a 75% improvement in leprosy type 2 reaction skin lesions at week 12"; 2027-12
NCT07187193
"Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH"; n 50; "Event-Free Survival (EFS)"; 2027-04-13
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Thalidomide could settle lifespan?
NCT06438679 measures Overall survival rate, reading out 2026-12.
7 open trials; n 133; "3T Therapy in the Treatment of MDA5-positive Dermatomyositis"
Show the evidence
Trial
NCT06438679
"3T Therapy in the Treatment of MDA5-positive Dermatomyositis"; n 133; "Overall survival rate"; 2026-12
NCT00602641
"Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma"; n 306; "Progression-Free Survival (PFS)"; 2027-02-20
NCT07187193
"Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH"; n 50; "Event-Free Survival (EFS)"; 2027-04-13
NCT03004287
"2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy"; n 50; "Measure the progression-free survival in patients with high risk multiple myeloma"; 2027-10
NCT00734877
"UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma"; n 382; "Progression-free survival rate"; 2028-09
NCT07671534
"Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors"; n 60; "Progression Free Survival (PFS)"; 2029-06
1 further recorded trialNCT07309419
"A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma"; n 222; "Overall Survival (OS)"; 2030-06-30
Q9
Which 116 trials of Thalidomide posted no result?
Posted no result
116 of 116 completed trials
Registrations
NCT00000790, NCT00004276, NCT00000812, NCT00004450, NCT00001446 and NCT00001680, and 110 more
Completion dates
oldest 1998-10; newest 2024-03-28
Show the evidence
Trial
NCT00000790
1998-10
NCT00004276
1999-06
NCT00000812
2000-07
NCT00004450
2000-11
NCT00001446
2001-07
NCT00001680
2001-07
14 further recorded trials
NCT00003754
2001-07
NCT00001599
2002-06
NCT00003894
2002-06
NCT00052416
2003-01
NCT00083707
2003-02
NCT00020046
2003-09
NCT00027638
2003-12
NCT00050843
2004-02
NCT00016224
2004-03
NCT00019123
2004-04
NCT00201357
2004-07
NCT00005815
2004-08
NCT00025285
2004-09-29
NCT00019539
2004-11
Q10
At the median, Thalidomide's trials enrolled 47 people — anything larger?
Median enrolment
47
Largest enrolment
1623
Registered trials counted
288
Q11
What do 4617 spontaneous reports say about Thalidomide — 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.
Thalidomide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4617 reaction mentions were counted: neuropathy peripheral 950; pneumonia 792; plasma cell myeloma 686; deep vein thrombosis 527. open-targets-adr · CHEMBL468 · 2026-06-24
Show the evidence
neuropathy peripheral
950
pneumonia
792
plasma cell myeloma
686
deep vein thrombosis
527
constipation
489
disease progression
444
4 more recorded rows
pulmonary embolism
408
multiple myeloma
120
blood human chorionic gonadotropin increased
104
plasma cell myeloma recurrent
97
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Thalidomide studied with exercise?
exercise is named in Thalidomide's label sentences: "Prophylactic enoxaparin was given to thalidomide recipients beginning in June 2001, and 122 subjects received prophylactic epoetin alfa (EPO) as part of an exercise trial." openfda-label+europepmc · 2011-06-30
1 recorded statement; exercise
Show the evidence
exercise
Prophylactic enoxaparin was given to thalidomide recipients beginning in June 2001, and 122 subjects received prophylactic epoetin alfa (EPO) as part of an exercise trial.
recorded 2011-06-30 · last checked 2026-09-04
Q13
What is recorded about Thalidomide and mTOR?
"It highlights approved drugs such as metformin, which acts on the AMPK/mTOR pathway to suppress cancer cell proliferation, thalidomide, which is approved for use in multiple myeloma because it has antiangiogenic and immunomodulatory effects, and propranolol, which inhibits β-adrenergic signaling, suppressing VEGF-induced angiogenesis in…" — where Thalidomide and mTOR appear together. Europe PMC · pathway abstract search · 2025-08-24
"It highlights approved drugs such as metformin, which acts on the AMPK/mTOR pathway to suppress cancer cell proliferation, thalidomide, which is approved for use in multiple myeloma because it has antiangiogenic and immunomodulatory effects, and propranolol, which inhibits β-adrenergic signaling, suppressing VEGF-induced angiogenesis in breast and ovarian cancer."
AMPK
PMID 40849858
"It highlights approved drugs such as metformin, which acts on the AMPK/mTOR pathway to suppress cancer cell proliferation, thalidomide, which is approved for use in multiple myeloma because it has antiangiogenic and immunomodulatory effects, and propranolol, which inhibits β-adrenergic signaling, suppressing VEGF-induced angiogenesis in breast and ovarian cancer."
PMID 36766811
"Thalidomide markedly decreased the degranulation and release of lipid mediators and cytokines in IgE/Ag-stimulated BMMCs, with concurrent inhibition of FcεRI-mediated positive signaling pathways including Syk and activation of negative signaling pathways including AMP-activated protein kinase (AMPK) and SH2 tyrosine phosphatase-1 (SHP-1)."
PMID 36766811
"The knockdown of AMPK or SHP-1 with specific siRNA diminished the inhibitory effects of thalidomide on BMMC activation."
mTORPMID 34944673
"Integrating RNA-seq data, public databases, and literature, TMPS analysis generated mathematical models which predicted that thalidomide acts via two CRBN-CRL4A- (CRL4<sup>CRBN</sup>) dependent pathways: IRF4/NF-ҡB and AMPK1/mTOR."
autophagy
PMID 34306363
"The aim of this study was to show the effects of autophagy inhibitor Wortmannin and antiangiogenic-proapoptotic Thalidomide on autophagy and apoptosis markers in 4T1 breast cancer cells in vitro and in vivo."
PMID 34306363
"Our findings suggest that autophagy is an important mechanism for 4T1 cells and both Wortmannin and Thalidomide treatments inhibit autophagy and induce apoptosis."
PMID 34306363
"The treatment of Wortmannin and Thalidomide increased the apoptotic cells in vivo independent from autophagy inhibition."
mTORPMID 33676575
"In such cases, therapeutic alternatives could be represented by Sirolimus, targeting PI3K/AKT/mTOR signaling or by associations of conventional drugs such as thalidomide, cyclophosphamide and prednisone."
sirtuinPMID 28379698
"Here we report the development of a proteolysis targeting chimera (PROTAC) based on the combination of the unique features of the sirtuin rearranging ligands (SirReals) as highly potent and isotype-selective Sirt2 inhibitors with thalidomide, a bona fide cereblon ligand."
IGF-1
PMID 22425187
"CCI and sham operated rats received two subcutaneous injections (one immediately after surgery, the other on postoperative day 5) containing either saline, GABA-reuptake inhibitor (NO-711), insulin-like growth factor-1 (IGF-1), ZVAD or thalidomide."
PMID 16832072
"Remaining agents (AEOL 10150, arimoclomol, celastrol, coenzyme Q10, copaxone, IGF-1-viral delivery, memantine, NAALADase inhibitors, nimesulide, scriptaid, sodium phenylbutyrate, thalidomide, trehalose) require additional preclinical animal data, human toxicity and pharmacokinetic data including CNS penetration prior to proceeding to large scale phase III human testing."
recorded 2025-08-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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