This page shows what was measured, who it was measured in, and what that does not settle.
What Tofacitinib does in the body
The treatment of adult patients
From the FDA-approved label: Tofacitinib 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. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. , JAK1/JAK3, JAK1/JAK2, JAK1/TyK2, JAK2/JAK2).
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
Its recorded molecular formula is C16H20N6O•C6H8O7, weighing 504.5 Daltons.
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 104 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports
✗ The study did not show it
Who was studied
NCT00413699
How many people
4488
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
Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
✗ The study did not show it
Who was studied
NCT02092467
How many people
4372
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
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
✗ The study did not show it
Who was studied
NCT04333147
How many people
2916
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
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
✗ The study did not show it
Who was studied
NCT01163253
How many people
2867
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
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
✗ The study did not show it
Who was studied
NCT03970837
How many people
1764
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
Percentage of Participants Achieving 20 Percentage (%) Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo
✗ The study did not show it
Who was studied
NCT03980483
How many people
1537
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.4 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 lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Non-human primate. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
maximum plasma concentration
disease activity 28 c reactive protein at week 12
Meaningful
Things that change how a life goes, not only a number.
2 year progression free survival
disease remission at 24 weeks
death
relapse rate at 12 months
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)
graft failure
who died
laboratory test abnormalities
treatment emergent adverse events
apparent oral clearance
clinically significant vital signs abnormalities
number and percentage of adverse events
vital signs
clinical lab testing
electrocardiogram
pharmacokinetics of abt 494
disease activity based on 28 joints count
treatment emergent adverse events and serious adverse events
adverse events by severity
severity of alopecia tool
oral clearance
occurrence of tuberculosis
treatment failure
american college of rheumatology 20 response
retention rates
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 3 hours hours
Read from the label, which states: “12.3 Pharmacokinetics Following oral administration of tofacitinib tablets, peak plasma concentrations were reached within 0.5 hour -1 hour, elimination half-life was about 3 hours and a dose-proportional increase in systemic exposure was observed in the therapeutic dosage range.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
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 tofacitinib tablets have not been established in pediatric patients less than 2 years of age.”
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
On older people, the label states: “Of the 3315 adults who were enrolled in clinical trials with RA (Studies RA- I to V), a total of 505 patients were 65 years of age and older, including 71 patients 75 years and older.”
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The available data with tofacitinib tablets from a pregnancy exposure registry that enrolled 11 exposed pregnant females, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.”
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Based on published data, tofacitinib is present in human milk.”
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
On people with reduced liver function, the label states: “Severe Hepatic Impairment Tofacitinib tablets have not been studied in patients with severe hepatic impairment (HI) (Child-Pugh C); therefore, use of tofacitinib tablets in patients with severe HI is not recommended.”
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
On people with reduced kidney function, the label states: “Moderate and Severe Renal Impairment Tofacitinib tablets-treated patients with moderate renal impairment (RI) (CLcr ≥30 and ≤50 mL/minute) or severe RI (<30 mL/minute) had greater tofacitinib blood concentrations than tofacitinibtablets-treated patients with normal renal function (CLcr >80 mL/minute).”
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, extended release, solution, tablet, film coated, extended release, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Tofacitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 36434 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
84 products list this as an active ingredient in the United States drug directory. 84 of them contain it and nothing else.
FDA National Drug Code directory · 0069-0501 · read 2026-08-29
They are sold as powder, solution, tablet, tablet, extended release, tablet, film coated and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 0069-0501 · 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 · 0069-0501 · read 2026-08-29
31 published labels name it as an active ingredient. 31 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-29
Tofacitinib is oral at 3 DOSAGE FORMS AND STRENGTHS Tofacitinib tablets: 5 mg tofacitinib: White to off white colored, round shaped, biconvex, film-coated tablets, debossed with “T1” on one side and “M” on other side. 10 mg tofacitinib: Blue…, recorded as fda label in effect 2026-08-13 in the United States.
US prescribing information · 253635c8-1ea7-41ba-b216-dea5e3305c47 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Tofacitinib studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Tofacitinib 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.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
Built from stored sources by fixed rules. No reviewer has signed it off.
How many documents were read
29 documents were read for this substance.
RNAWiki source record
28 of them state the same bioavailability, and they agree.
RNAWiki source record
29 of them state the same proteinBinding, and they agree.
RNAWiki source record
29 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
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How this medicine reached us
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What the approval register records
32 approved applications cover products containing this substance. The earliest was NDA203214, approved 20121106 to PF PRISM CV.
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6 questions this page could not answer
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Recorded evidence blocks (13)
Q2
What did Tofacitinib's largest trial (105711 people) and its longest (21 years) measure?
105711 people in Tofacitinib's largest registered study, 21 years in its longest registered window, measuring All-cause mortality at 6 months from treatment initiation. ClinicalTrials.gov · 2026-09-01
45 phase2, 29 phase4, 26 phase3, 24 na or unstated, 23 phase1, 9 na, 7 early phase1; NCT03414502; 2029-03; no ageing endpoint recorded. Last human test completed 2026, NCT05662228.
Interpretation These counts include studies where Tofacitinib 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
45
phase4
29
phase3
26
na or unstated
24
phase1
23
na
9
2 more recorded rows
early phase1
7
Last recorded human testNCT05662228
2026-05-28
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Tofacitinib shown lifespan?
"unable to identify additional subjects to qualify for enrollment"; 8 of 155 registered studies
Show the evidence
Trial
NCT03159936
terminated; "unable to identify additional subjects to qualify for enrollment"
NCT03970837
terminated; "Only Asia cohort is early terminated.Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory…"
NCT04311567
terminated; "Low recruitment due to the pandemic and high screening failure rate in particular because of low prevalence of interstitial abnormalities at diagnosis in Sweden."
NCT04412252
withdrawn; "Due to the pursuit of other SARS-CoV-2-related research including alternative trials with tofacitinib, this trial was canceled prior to subject enrollment."
NCT04415151
terminated; "Study terminated due to lack of enrollment reflecting the decrease in number of COVID infections. There were no safety and/or efficacy concerns involved in the decision to stop enrollment."
NCT04580277
terminated; "low recruitment"
2 further recorded trials
NCT04768504
terminated; "sponsor decision, due to low recruitment rate"
NCT05165771
withdrawn; "Sponsor decision to withdraw study."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Tofacitinib used Tasocitinib 10 mg oral tablet — over how long?
Tofacitinib 5mg [Xeljanz] 1 year open-label extension
humanNCT03868072
XELJANZ 5Mg Tablet
humanNCT04062695
Tofacitinib 5 MG Oral Tablet [Xeljanz]
humanNCT04114461
Xeljanz tab. 5mg
humanNCT04431895
Tofacitinib 5 MG
humanNCT04973033
Tofacitinib 5mg.bid.po.
humanNCT05326464
Tofacitinib 10mg
humanNCT05749666
Placebo of tofacitinib 5mg
humanNCT07406035
Tofacitinib Citrate Tablet 5 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tofacitinib's half-life is 3 hours — which schedules were studied?
3 hours, the half-life Tofacitinib's label states. openfda-label · 58b94979-55ad-839a-e063-6294a90ad812 · 2026-08-30
bioavailability 74% %.
Show the evidence
half life
3 hours hours; 12.3 Pharmacokinetics Following oral administration of tofacitinib tablets, peak plasma concentrations were reached within 0.5 hour -1 hour, elimination half-life was about 3 hours and a dose-proportional increase in systemic exposure was observed in the therapeutic dosage range.
tmax
Table 8: Pharmacokinetic Parameters of Tofacitinib Tablets/Tofacitinib Extended-Release Tablets Following Multiple Oral Dosing Abbreviations: AUC 24 = area under the concentration time profile from time 0 to 24 hours; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; Tmax = time to Cmax; CV = Coefficient of variation. aValues represent the geometric mean, except Tmax, for…
bioavailability
74% %; Absorption Tofacitinib tablets The absolute oral bioavailability of tofacitinib tablets is 74%.
metabolism
Metabolism and Excretion Clearance mechanisms for tofacitinib are approximately 70% hepatic metabolism and 30% renal excretion of the parent drug.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 2 year progression free survival, adhering to the allocated treatment and adverse events did Tofacitinib's trials measure?
2 year progression free survival, adhering to the allocated treatment and adverse events lead 40 outcome terms across Tofacitinib's trials. ClinicalTrials.gov · 2026-09-01
Interpretation treatment emergent adverse events, apparent oral clearance, clinically significant vital signs abnormalities, maximum plasma concentration, number and percentage of adverse events and vital signs follow.
Show the evidence
graft failure
1
who died
1
laboratory test abnormalities
1
treatment emergent adverse events
1
apparent oral clearance
1
clinically significant vital signs abnormalities
1
14 more recorded rows
maximum plasma concentration
1
number and percentage of adverse events
1
vital signs
1
clinical lab testing
1
electrocardiogram
1
pharmacokinetics of abt 494
1
disease activity based on 28 joints count
1
treatment emergent adverse events and serious adverse events
1
adverse events by severity
1
severity of alopecia tool
1
oral clearance
1
occurrence of tuberculosis
1
treatment failure
1
2 year progression free survival
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Tofacitinib's 40 ongoing trials reports first?
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis; Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition; latest 2030-12-30
Show the evidence
Trial
NCT03414502
"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response"; n 400; "Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"; 2029-03
NCT03681275
"Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction"; n 70; "Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition"; 2026-11-30
NCT03976245
"Advanced Therapeutics in Rheumatoid Arthritis (RA)"; n 144; "Retention Rates"; 2025-03
NCT04496960
"Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome"; n 23; "Number of Adverse Events by Grade/Category"; 2026-09-22
NCT04624230
"Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis"; n 118; "Remission by central read Mayo score following 44 weeks in the maintenance phase."; 2029-06-06
NCT04871191
"Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis"; n 42; "Proportion of patients with a response or a remission"; 2029-03
14 further recorded trials
NCT04876781
"Korean Post-marketing Surveillance for Xeljanz XR"; n 200; "Number of Participants With Treatment Emergent Adverse Events (AEs)"; 2026-09-22
NCT05102448
"Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis"; n 76; "The effectiveness rate after 6 months' treatment"; 2025-12-31
NCT05305066
"Stand UP to Rheumatoid Arthritis (SUPRA)"; n 75; "Rate of recruitment at two RA referral centers over 12 months"; 2030-12
NCT05313620
"Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events"; n 30; "platelet activation"; 2025-12
NCT05754710
"Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis"; n 10; "Number of patients with treatment emergent treatment-related adverse events"; 2026-09-30
NCT05845723
"Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome"; n 81; "The primary endpoint is the complete response (CR) rate at week 12."; 2027-06-01
NCT06020144
"A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs"; n 459; "Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response"; 2026-12-31
NCT06095128
"A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)"; n 65; "Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score"; 2027-07-09
NCT06112665
"ToFAcitinib in Early Active Axial SpondyloarThritis:"; n 104; "Main trial endpoint"; 2026-06
NCT06119490
"Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis"; n 30; "Time to Reepithelization"; 2026-09
NCT06438679
"3T Therapy in the Treatment of MDA5-positive Dermatomyositis"; n 133; "Overall survival rate"; 2026-12
NCT06498089
"A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis"; n 124; "Effectiveness rate"; 2027-06-30
NCT06573593
"Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study"; n 150; "Mean SALT"; 2026-12-31
NCT06625450
"TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS"; n 75; "Time to relapse of colitis"; 2026-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Tofacitinib could settle inflammatory markers?
NCT07177209 measures Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis., reading out 2026-07-31.
3 open trials; n 4000; "Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"
Show the evidence
Trial
NCT07177209
"Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population"; n 4000; "Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis."; 2026-07-31
NCT06438679
"3T Therapy in the Treatment of MDA5-positive Dermatomyositis"; n 133; "Overall survival rate"; 2026-12
NCT07775235
"Treatment Response in Immune-mediated Myositis Associated Rapidly-progressing Interstitial Lung Disease"; n 80; "All-cause mortality at 6 months from treatment initiation"; 2029-07-01
Q10
Which 32 trials of Tofacitinib posted no result?
Posted no result
32 of 32 completed trials
Registrations
NCT01143805, NCT01599377, NCT01741493, NCT02566967, NCT02535689 and NCT03868072, and 26 more
Completion dates
oldest 2010-08; newest 2024-05-28
Show the evidence
Trial
NCT01143805
2010-08
NCT01599377
2012-07
NCT01741493
2013-12
NCT02566967
2018-03-20
NCT02535689
2018-04-26
NCT03868072
2019-04-20
14 further recorded trials
NCT03736161
2019-09-28
NCT04114461
2019-12-04
NCT04111614
2019-12-12
NCT04750317
2020-09-01
NCT03002649
2020-09-30
NCT04468425
2020-12-21
NCT04552197
2020-12-29
NCT04469114
2021-01-09
NCT04973033
2021-01-31
NCT04529876
2021-08-31
NCT04985955
2021-09-21
NCT04772248
2021-12-30
NCT04799262
2022-05-01
NCT04798287
2022-05-16
Q11
At the median, Tofacitinib's trials enrolled 75 people — anything larger?
Median enrolment
75
Largest enrolment
105711
Registered trials counted
155
Q12
What do 36434 spontaneous reports say about Tofacitinib — 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.
Tofacitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 36434 reaction mentions were counted: pain 4983; arthralgia 4868; fatigue 4294; rheumatoid arthritis 3934. open-targets-adr · CHEMBL2103743 · 2026-06-24
Show the evidence
pain
4983
arthralgia
4868
fatigue
4294
rheumatoid arthritis
3934
condition aggravated
3886
joint swelling
3522
4 more recorded rows
headache
3351
rash
2638
pain in extremity
2503
musculoskeletal stiffness
2455
recorded 2026-06-24 · last checked 2026-09-04
Q13
Tofacitinib and CYP3A4, CYP2C19 and P-GLYCOPROTEIN: shared by which compounds?
CYP3A4, CYP2C19 and P-GLYCOPROTEIN appear in Tofacitinib's recorded interaction sentences, 12 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
CYP2B6pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
CYP2C19
pharmacokinetics
The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
pharmacokinetics
Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to substantially alter the pharmacokinetics of tofacitinib (see Figure 3).
CYP2C8pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
CYP2C9pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
CYP2D6pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
CYP3A4
pharmacokinetics
The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
pharmacokinetics
Drug Interaction Studies Potential for tofacitinib tablets to Influence the PK of Other Drugs In vitro studies indicate that tofacitinib does not significantly inhibit or induce the activity of the major human drug-metabolizing CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at concentrations corresponding to the steady state C max of a 10 mg twice daily dose.
pharmacokinetics
Potential for Other Drugs to Influence the Pharmacokinetics of Tofacitinib Since tofacitinib is metabolized by CYP3A4, interaction with drugs that inhibit or induce CYP3A4 is likely.
pharmacokinetics
These in vitro results were confirmed by a human drug interaction study showing no changes in the pharmacokinetics of midazolam, a highly sensitive CYP3A4 substrate, when concomitantly administered with tofacitinib tablets.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Tofacitinib and autophagy?
"Autophagy induction and mitochondrial quality control modulation by tofacitinib might contribute to FLS function restoration." — where Tofacitinib and autophagy appear together. Europe PMC · pathway abstract search · 2025-07-07
"Autophagy induction and mitochondrial quality control modulation by tofacitinib might contribute to FLS function restoration."
PMID 37310645
"The objective of this study was to investigate the effect of tofacitinib on the cartilage extracellular matrix in OA and determine whether tofacitinib exerts a protective effect by inhibiting the JAK1/STAT3 signaling pathway and upregulating autophagy in chondrocytes."
mTORPMID 40620171
"JAK inhibitors, mainly tofacitinib, exhibited encouraging results in case reports, small retrospective series, and two prospective open-label trials for skin and pulmonary sarcoidosis. mTOR inhibitors demonstrated efficacity in one cross-over study on skin involvement."
autophagyPMID 35308233
"Since hyperactive autophagy has been associated with impaired apoptosis of RA fibroblast-like synoviocytes (FLS), we aimed to investigate the role of tofacitinib in modulating autophagy and apoptosis in these cells."
AMPK
PMID 32365634
"Similar to tofacitinib and D942 (an AMPK activator), BJ-3105 inhibited IL-6-induced JAK2/STAT3 phosphorylation and TNF-α-stimulated activation of IKK/NF-κB, and consequently, stimulus-induced upregulations of inflammatory cytokines and inflammasome components."
PMID 32365634
"Taken together, our findings suggest BJ-3105, which exerted a much better anti-colitis effect than tofacitinib through AMPK activation and NOX inhibition, is a promising candidate for the treatment of IBD."
mTOR
PMID 35694243
"In recent years, varieties of immunosuppressive agents have been approved for clinical use, such as the JAK inhibitor tofacitinib and the mTOR inhibitor everolimus, which have shown good therapeutic effects."
PMID 36996348
"Therapies of potential interest and wider use in CVID include mTOR-inhibitors like sirolimus, JAK-inhibitors like tofacitinib, the monoclonal IL-12/23 antibody ustekinumab, the anti-BAFF antibody belimumab and abatacept."
recorded 2025-07-07 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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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