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Baricitinib

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Baricitinib does in the body

Moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis fac

From the FDA-approved label: Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. , JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, JAK2/JAK2, JAK2/TYK2).

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 · ISP4442I3Y · read 2026-08-29

  • Its recorded molecular formula is C16H17N7O2S, weighing 371.42.

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · 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 120 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 peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Healthy ageingWaiting for a reviewer3 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
RecoveryNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
all cause mortality; community acquired pneumonia all cause mortality; influenza co primary outcome all cause mortality
Blood sugar
phase 2 changes in glucose through day 15
Recovery
time to recovery

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Waiting for a reviewer
3 registered study measure of this kind. No reviewed result yet.
Nothing in the sources checked
No registered study lists a performance measure for this goal.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
1 registered test measure.

What happened in peopleRead 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.

Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)

The study did not show it

Who was studied
NCT04381936
How many people
70000
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

All-cause mortality

The study did not show it

Who was studied
NCT02735707
How many people
20000
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 to severe dengue/critical dengue

The study did not show it

Who was studied
NCT07543458
How many people
8800
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Prevention of very severe respiratory failure or mortality

The study did not show it

Who was studied
NCT04832880
How many people
4000
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

Number of Participants Who Experienced Adverse Events (AEs) or Serious AE

The study did not show it

Who was studied
NCT01885078
How many people
2877
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]

The study did not show it

Who was studied
NCT03915964
How many people
2659
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
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 peopleRead 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.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.3 registered measures of this kind. 2 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No 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 takeRead 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.

  • phase 2 changes in hemoglobin through day 15
  • phase 2 changes in creatinine through day 15
  • phase 2 changes in glucose through day 15

Meaningful

Things that change how a life goes, not only a number.

  • all cause mortality
  • community acquired pneumonia all cause mortality
  • influenza co primary outcome all cause mortality

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 (34)
  • achieving american college of rheumatology 20 improvement
  • clinically significant effects
  • achieving psoriasis area and severity index 75 improvement
  • days alive and not receiving organ support in icu
  • phase 1 number of dose limiting toxicities
  • adverse events
  • changes of molecular profiles over time
  • changes of molecular profiles associated treatment
  • changes of molecular profiles associated treatment response
  • achieving eczema area and severity index 75
  • alkaline phosphatase
  • one or more serious adverse event
  • permanent investigational product discontinuations
  • treatment emergent adverse events
  • adverse events of special interest
  • serious adverse events
  • cumulative incidence of graft failure
  • clinical status of at day 15
  • phase 2 cumulative incidence of grade 3 and 4 adverse events
  • phase 2 cumulative incidence of serious adverse events

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead 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.

  • OLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. ( 1.1 ) Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

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 OLUMIANT in pediatric patients have not been established.”

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-30

  • On older people, the label states: “Of the 3100 patients treated in the rheumatoid arthritis clinical trials, a total of 537 patients were 65 years of age and older, including 71 patients 75 years of age and older.”

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on the findings from animal reproduction studies, OLUMIANT may cause fetal harm during pregnancy.”

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary No information is available on the presence of OLUMIANT in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.”

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is necessary in patients with mild or moderate hepatic impairment.”

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-30

  • On people with reduced kidney function, the label states: “Renal function was found to significantly affect baricitinib exposure.”

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · 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 takeRead 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 takeRead 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, S4, S6.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, 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 takeNothing 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.

Baricitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 391 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • deep vein thrombosis — 67 reaction mentions
  • pulmonary embolism — 63 reaction mentions
  • rheumatoid arthritis — 59 reaction mentions
  • covid-19 — 47 reaction mentions
  • herpes zoster — 39 reaction mentions
  • therapy interrupted — 35 reaction mentions
  • alanine aminotransferase increased — 34 reaction mentions
  • liver function test increased — 19 reaction mentions
  • fibrin d dimer increased — 15 reaction mentions
  • covid-19 pneumonia — 13 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 unclearRead 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

  • 12 products list this as an active ingredient in the United States drug directory. 12 of them contain it and nothing else.

    FDA National Drug Code directory · 63419-0552 · read 2026-08-29

  • They are sold as crystal, powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 63419-0552 · read 2026-08-29

  • The regulator's established pharmacologic class for it is janus kinase inhibitor [epc] and janus kinase inhibitors [moa].

    FDA National Drug Code directory · 63419-0552 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · read 2026-08-29

  • Olumiant is oral at 3 DOSAGE FORMS AND STRENGTHS OLUMIANT is available as debossed, film-coated tablets: 1 mg tablet contains a recessed area on each face of the tablet surface, is very light pink, round, debossed with “Lilly” on one side…, recorded as fda label in effect 2026-06-30 in the United States.

    US prescribing information · 866e9f35-9035-4581-a4b1-75a621ab55cf · 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 takeRead 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 Baricitinib 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 unclearRead 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 Baricitinib 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.

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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)
ISP4442I3Y
RxNorm concept
2047241

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How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 3 approved applications cover products containing this substance. The earliest was NDA207924, approved 20180531 to ELI LILLY AND CO.

    Drugs@FDA application register · NDA207924 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA207924 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20160415.

    FDA National Drug Code directory · 63419-0552 · read 2026-08-29

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6 questions this page could not answer

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Recorded evidence blocks (13)

What did Baricitinib's largest trial (70000 people) and its longest (21 years) measure?


70000 people in Baricitinib's largest registered study, 21 years in its longest registered window, measuring All-cause mortality. ClinicalTrials.gov · 2026-09-01

66 phase2, 54 phase3, 27 phase1, 12 phase4, 8 na or unstated, 7 na, 1 early phase1; NCT03414502; 2029-03; no ageing endpoint recorded. Last human test completed 2026, NCT07645430.

Interpretation These counts include studies where Baricitinib 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
    66
  • phase3
    54
  • phase1
    27
  • phase4
    12
  • na or unstated
    8
  • na
    7
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT07645430
    2026-06-09

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Baricitinib shown lifespan?


mouse: lifespan, rat: mechanism-only and human: lifespan (159): the rungs where Baricitinib has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation All-cause mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • mouse
    lifespan
  • rat
    mechanism-only
  • human NCT02735707
    lifespan; All-cause mortality; 159

recorded 2026-09-01 · last checked 2026-09-04

13 of Baricitinib's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?


safety (1), futility/efficacy (2), accrual/recruitment (3), funding/business (1) and other (6): Baricitinib's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Terminated due to lack of alignment during regulatory negotiations."; 13 of 159 registered studies

Show the evidence

Trial

  • NCT03559270
    terminated; "Terminated due to lack of alignment during regulatory negotiations."
  • NCT03616912
    terminated; "Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients."
  • NCT03742973
    terminated; "Study was terminated due to enrollment futility."
  • NCT03843125
    terminated; "Study terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data"
  • NCT04340232
    withdrawn; "Could not make FDA required changes"
  • NCT04373044
    terminated; "The study was terminated after the release of results of ACTT-2 (NCT04401579)."
7 further recorded trials
  • NCT04517253
    terminated; "The study was terminated due to efficacy/effectiveness reasons"
  • NCT04891133
    terminated; "The trial was stopped prematurely due to external evidence that arose during the study period showing that the IMP, baricitinib, was not effective in the primary study population."
  • NCT04970719
    withdrawn; "adequate cases were not available"
  • NCT05074420
    terminated; "Study terminated due to an inability to enroll participants."
  • NCT05238896
    terminated; "Difficulties of inclusion in the study following expiry of the experimental treatment. The time required to supply the study treatment is too long to obtain conclusive results at the end of the study."
  • NCT05361109
    withdrawn; "Difficulty recruiting subjects"
  • NCT05858515
    withdrawn; "This submission for the pilot study has been withdrawn as the full trial opened under a different NCT number before participants enrolled in the pilot."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Baricitinib used Baricitinib 4 MG Oral Tablet — over how long?


studies of Baricitinib used the recorded amount. ClinicalTrials.gov · 2026-09-01

11 recorded entries; human; also "Baricitinib 4 MG Oral Tablet", "Baricitinib 2 MG", "Baricitinib (LY3009104) 2 mg"

Show the evidence

human

  • NCT04358614
    Baricitinib 4 MG Oral Tablet
  • NCT04916756
    Baricitinib 2 MG
  • NCT05188521
    Baricitinib (LY3009104) 2 mg
  • NCT05188521
    Baricitinib (LY3009104) 4 mg
  • NCT05452564
    Baricitinib 2 MG Oral Tablet
  • NCT05651880
    Baricitinib 4 MG
5 more recorded rows
  • human NCT05827497
    Baricitinib 2mg
  • human NCT05852847
    Baricitinib 2 MG [Olumiant]
  • human NCT07081763
    Placebo of baricitinib 2 MG
  • human NCT07449910
    2mg Baricitinib
  • human NCT07449910
    4mg Baricitinib

recorded 2026-09-01 · last checked 2026-09-04

Which of achieving american college of rheumatology 20 improvement, achieving eczema area and severity index 75 and achieving psoriasis area and severity index 75 improvement did Baricitinib's trials measure?


achieving american college of rheumatology 20 improvement, achieving eczema area and severity index 75 and achieving psoriasis area and severity index 75 improvement lead 40 outcome terms across Baricitinib's trials. ClinicalTrials.gov · 2026-09-01

all cause mortality, days alive and not receiving organ support in icu, phase 1 number of dose limiting toxicities, adverse events, changes of molecular profiles over time and changes of molecular profiles associated treatment follow.

Show the evidence
  • achieving american college of rheumatology 20 improvement
    1
  • clinically significant effects
    1
  • achieving psoriasis area and severity index 75 improvement
    1
  • all cause mortality
    1
  • days alive and not receiving organ support in icu
    1
  • phase 1 number of dose limiting toxicities
    1
14 more recorded rows
  • adverse events
    1
  • changes of molecular profiles over time
    1
  • changes of molecular profiles associated treatment
    1
  • changes of molecular profiles associated treatment response
    1
  • achieving eczema area and severity index 75
    1
  • alkaline phosphatase
    1
  • one or more serious adverse event
    1
  • permanent investigational product discontinuations
    1
  • treatment emergent adverse events
    1
  • adverse events of special interest
    1
  • serious adverse events
    1
  • cumulative incidence of graft failure
    1
  • clinical status of at day 15
    1
  • phase 2 cumulative incidence of grade 3 and 4 adverse events
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Baricitinib's 51 ongoing trials reports first?


51 registered trials of Baricitinib are open; earliest completion 2025-10. ClinicalTrials.gov · 2026-09-01

All-cause mortality; Changes of molecular profiles over time; latest 2038-09-30

Show the evidence

Trial

  • NCT02735707
    "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02
  • NCT03358693
    "Molecular Signatures in Inflammatory Skin Disease"; n 300; "Changes of molecular profiles over time"; 2029-12-31
  • NCT03414502
    "Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response"; n 400; "Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"; 2029-03
  • NCT03773965
    "A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis"; n 190; "Number of Participants with One or More Serious Adverse Event(s) (SAEs)"; 2031-07
  • NCT04088396
    "A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)"; n 58; "Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12"; 2026-10
  • NCT04088409
    "A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis"; n 30; "Part A: Percentage of Responders for Baricitinib at Week 24"; 2028-07
14 further recorded trials
  • NCT04381936
    "Randomised Evaluation of COVID-19 Therapy"; n 70000; "Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)"; 2038-09-30
  • NCT04972760
    "Baricitinib in Patients With Relapsing or naïve Dermatomyositis"; n 62; "Moderate improvement at 24 weeks without prednisone: prednisone-free moderate improvement."; 2028-02-28
  • NCT05003310
    "ConsideRAte Study - Splenic Stimulation for RA"; n 28; "Incidence of Adverse Events [Safety and Tolerability]"; 2032-04
  • NCT05300932
    "A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis"; n 60; "Change in modified Rodnan skin score (mRSS) at week 24"; 2026-11-12
  • NCT05305066
    "Stand UP to Rheumatoid Arthritis (SUPRA)"; n 75; "Rate of recruitment at two RA referral centers over 12 months"; 2030-12
  • NCT05452564
    "Baricitinib for Reduction of HIV - CNS"; n 95; "Changes in CSF integrated proviral DNA"; 2028-01
  • NCT05651880
    "Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis"; n 33; "Number of patients with complete remission"; 2029-12
  • NCT05674695
    "Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy"; n 2500; "Rates of adverse events"; 2029-01-01
  • NCT05723198
    "A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata"; n 595; "Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20"; 2033-09
  • NCT05792462
    "Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders"; n 11; "The number of relapses"; 2027-03-01
  • NCT05849038
    "Inflammation and Depression in People With HIV"; n 60; "Change in corticostriatal functional connectivity (FC) in reward circuit"; 2027-11
  • NCT05955066
    "Effect of JAK Inhibitor on Erosion Healing in RA"; n 60; "The proportion of patients with reduction of erosion volume on HR-pQCT over 2-4 metacarpophalangeal (MCP 2-4) at 24 weeks comparing JAK inhibitor group and placebo group."; 2026-06
  • NCT06065046
    "Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions"; n 100; "Clinical improvement"; 2026-12-31
  • NCT06158113
    "Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study"; n 10; "Change in Oral Disease Severity Scale (ODSS) Scores"; 2026-09

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Baricitinib could settle inflammatory markers?


NCT06768294 measures The evaluation the effect of baricitinib on inflammation of the synovial membrane in CPPD, reading out 2027-01.

4 open trials; n 32; "Baricitinib in CPPD - the BAPTIST Study"

Show the evidence

Trial

  • NCT06768294
    "Baricitinib in CPPD - the BAPTIST Study"; n 32; "The evaluation the effect of baricitinib on inflammation of the synovial membrane in CPPD"; 2027-01
  • NCT02735707
    "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02
  • NCT06381661
    "Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial"; n 2000; "All-cause mortality"; 2031-07-09
  • NCT04381936
    "Randomised Evaluation of COVID-19 Therapy"; n 70000; "Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)"; 2038-09-30

Which 14 trials of Baricitinib posted no result?


Posted no result
14 of 14 completed trials
Registrations
NCT04358614, NCT04916756, NCT05006768, NCT05302947, NCT05082714 and NCT04131738, and 8 more
Completion dates
oldest 2020-04-07; newest 2024-06-08
Show the evidence

Trial

  • NCT04358614
    2020-04-07
  • NCT04916756
    2021-03-25
  • NCT05006768
    2021-06-24
  • NCT05302947
    2021-06-30
  • NCT05082714
    2022-06-04
  • NCT04131738
    2022-08-17
8 further recorded trials
  • NCT05112120
    2023-08-03
  • NCT04027101
    2023-08-30
  • NCT04208464
    2023-09-25
  • NCT05660655
    2023-09-30
  • NCT03945760
    2023-10-16
  • NCT04774224
    2024-05-06
  • NCT05080218
    2024-05-28
  • NCT06662721
    2024-06-08

At the median, Baricitinib's trials enrolled 94.5 people — anything larger?


Median enrolment
94.5
Largest enrolment
70000
Registered trials counted
158

What do 391 spontaneous reports say about Baricitinib — 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.

Baricitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 391 reaction mentions were counted: deep vein thrombosis 67; pulmonary embolism 63; rheumatoid arthritis 59; covid-19 47. open-targets-adr · CHEMBL2105759 · 2026-06-24

Show the evidence
  • deep vein thrombosis
    67
  • pulmonary embolism
    63
  • rheumatoid arthritis
    59
  • covid-19
    47
  • herpes zoster
    39
  • therapy interrupted
    35
4 more recorded rows
  • alanine aminotransferase increased
    34
  • liver function test increased
    19
  • fibrin d dimer increased
    15
  • covid-19 pneumonia
    13

recorded 2026-06-24 · last checked 2026-09-04

Baricitinib and OAT3, PGP and BCRP: shared by which compounds?


OAT3, PGP and BCRP appear in Baricitinib's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP2C19 pharmacokinetics
    There were no clinically meaningful changes in the PK of baricitinib when co-administered with fluconazole (CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (CYP3A inducer).
  • CYP2C9 pharmacokinetics
    There were no clinically meaningful changes in the PK of baricitinib when co-administered with fluconazole (CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (CYP3A inducer).

CYP3A4

  • pharmacokinetics
    Metabolism – Approximately 6% of the orally administered baricitinib dose is identified as metabolites (three from urine and one from feces), with CYP3A4 identified as the main metabolizing enzyme.
  • pharmacokinetics
    Figure 2 Potential for Other Drugs to Influence the PK of Baricitinib In vitro studies suggest that baricitinib is a CYP3A4 substrate.

recorded 2026-08-30 · last checked 2026-09-04

Was Baricitinib studied with fasting?


fasting is named in Baricitinib's label sentences: "Quantitative response score (QRS), fasting C-peptide, and model-estimated C-peptide (CPest) most reliably differentiated placebo-treated from baricitinib-treated participants at 24 and 48 weeks." openfda-label+europepmc · 2026-08-30

1 recorded statement; fasting

Show the evidence
  • fasting
    Quantitative response score (QRS), fasting C-peptide, and model-estimated C-peptide (CPest) most reliably differentiated placebo-treated from baricitinib-treated participants at 24 and 48 weeks.

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Baricitinib and mTOR?


"These findings indicate that baricitinib exerts robust neuroprotective effects in a ketamine model of schizophrenia, accompanied by attenuation of neuroinflammation and modulation of the JAK/STAT and PI3K/AKT/mTOR pathways." — where Baricitinib and mTOR appear together. Europe PMC · pathway abstract search · 2026-08-19

mTOR, IGF-1, autophagy, AMPK; PMID 42617472, 41861528, 41993576, 39121587

Show the evidence
  • mTOR PMID 42617472
    "These findings indicate that baricitinib exerts robust neuroprotective effects in a ketamine model of schizophrenia, accompanied by attenuation of neuroinflammation and modulation of the JAK/STAT and PI3K/AKT/mTOR pathways."
  • IGF-1 PMID 41861528
    "Our findings suggest that oral administration of baricitinib impairs postnatal growth and development in juvenile rats, likely through the GH/JAK2/IGF-1 axis."
  • mTOR PMID 41993576
    "Baricitinib also increased miR-126a-3p expression in macrophage-derived exosomes. miR-126a-3p exerted antifibrotic effects by regulating apoptosis and autophagy via the PI3K/AKT1/mTOR pathway."
  • autophagy PMID 41993576
    "Baricitinib also increased miR-126a-3p expression in macrophage-derived exosomes. miR-126a-3p exerted antifibrotic effects by regulating apoptosis and autophagy via the PI3K/AKT1/mTOR pathway."
  • mTOR PMID 39121587
    "Baricitinib reduced p-ULK1 (Ser757) and enhanced mitophagy by inhibiting the JAK2-AKT-mTOR signaling pathway."
  • AMPK
    "Additional important modulators including camostat as an inhibitor of TMPRSS2, baricitinib targeting JAK and STAT signaling, sulforaphane as a Nrf2 activator, and metformin as an AMPK activator were incorporated into an inhalable nano-liposomal formulation strategy aimed at inhibiting viral propagation and resultant downstream immune storms."

recorded 2026-08-19 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2105759
PubChem CID
44205240
CAS number
1187594-09-7
RxCUI
2047232
InChIKey
XUZMWHLSFXCVMG-UHFFFAOYSA-N
Also called
3JW, INCB-028050, INCB028050, Incb-28050, LY-3009104, LY3009104, OLUMIANT, BARICITINIB [EMA EPAR], BARICITINIB [JAN], BARICITINIB [MI], BARICITINIB [ORANGE BOOK], BARICITINIB [USAN]
Salt form
BARICITINIB PHOSPHATE, Baricitinib phosphate salt
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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