This page shows what was measured, who it was measured in, and what that does not settle.
What Upadacitinib does in the body
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor.
From the FDA-approved label: Upadacitinib 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. Upadacitinib 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).
Why people take it. RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor.
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 · 4RA0KN46E0 · read 2026-08-29
Its recorded molecular formula is C17H19F3N6O, weighing 389.38 g/mol.
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 117 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
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.
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.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
✗ The study did not show it
Who was studied
NCT03104400
How many people
1705
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 an American College of Rheumatology 20% (ACR20) Response at Week 12
✗ The study did not show it
Who was studied
NCT02629159
How many people
1629
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
Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
✗ The study did not show it
Who was studied
NCT03568318
How many people
1533
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 the Achievement of Severity of Alopecia Tool (SALT) Score <= 20
✗ The study did not show it
Who was studied
NCT06012240
How many people
1500
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 Hidradenitis Suppurative Clinical Response (HiSCR) 50
✗ The study did not show it
Who was studied
NCT05889182
How many people
1328
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
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
✗ The study did not show it
Who was studied
NCT02819635
How many people
1302
Study design
Phase 2/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.3 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.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■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.
disease activity 28 c reactive protein at week 12
maximum plasma concentration
time to maximum observed plasma concentration
Meaningful
Things that change how a life goes, not only a number.
achieving clinical remission based on das28 at week 12
8th week endoscopic remission rate
achieving clinical remission based on the cdai at week 12
steroid free clinical remission
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (33)
number and percentage of adverse events
vital signs
clinical lab testing
electrocardiogram
an american college of rheumatology 20 response over time
an american college of rheumatology 50 response over time
an american college of rheumatology 70 response over time
an american college of rheumatology 20 response at week 12
an american college of rheumatology 20 response at week 14
eczema area and severity index at week 16
sub study 1 percentage of endoscopic response
adverse events
endoscopic response at week 12
changes of molecular profiles over time
changes of molecular profiles associated treatment
changes of molecular profiles associated treatment response
oral clearance
treatment emergent adverse events
experiencing adverse events
treatment emergent adverse events of special interest
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. 8 to 14 hours hours
Read from the label, which states: “Upadacitinib mean terminal elimination half-life ranged from 8 to 14 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis 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 RINVOQ LQ in pediatric patients with atopic dermatitis have not been established.”
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
On older people, the label states: “Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ulcerative colitis to determine whether they respond differently from younger adult patients.”
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
On people who are pregnant, the label states: “Surveillance Program There is a pregnancy surveillance program for RINVOQ/RINVOQ LQ that monitors pregnancy outcomes in women exposed to RINVOQ/RINVOQ LQ.”
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
On people with reduced liver function, the label states: “The use of RINVOQ/RINVOQ LQ has not been studied in patients with severe hepatic impairment (Child Pugh C), and is therefore not recommended [see Dosage and Administration ( 2.12 ) and Clinical Pharmacology ( 12.3 )] .”
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
On people with reduced kidney function, the label states: “For patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, pJIA, or giant cell arteritis no dosage adjustment is needed in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2 ), moderate (eGFR 30 to < 60 mL/min/1.73 m 2 ), or severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m 2 ).”
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S6.
No source is stored against this line.
What is in the pack
Sold as tablet, extended release, solution, tablet, 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.
Upadacitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 721 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
therapy interrupted — 204 reaction mentions
covid-19 — 110 reaction mentions
urinary tract infection — 92 reaction mentions
herpes zoster — 66 reaction mentions
rheumatoid arthritis — 58 reaction mentions
infection — 55 reaction mentions
illness — 50 reaction mentions
sinusitis — 49 reaction mentions
localised infection — 24 reaction mentions
sars-cov-2 test positive — 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 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
17 products list this as an active ingredient in the United States drug directory. 17 of them contain it and nothing else.
FDA National Drug Code directory · 0074-2306 · read 2026-08-29
They are sold as powder, solution, tablet and tablet, extended release, taken oral.
FDA National Drug Code directory · 0074-2306 · 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 · 0074-2306 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · read 2026-08-29
Rinvoq is oral at 3 DOSAGE FORMS AND STRENGTHS RINVOQ extended-release tablets: 15 mg upadacitinib: purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side. 30 mg upadacitinib: red, biconvex oblong, wit…, recorded as fda label in effect 2026-06-30 in the United States.
US prescribing information · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · 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 Upadacitinib 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 Upadacitinib are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
4RA0KN46E0
RxNorm concept
2196894
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: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
4 approved applications cover products containing this substance. The earliest was NDA211675, approved 20190816 to ABBVIE.
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6 questions this page could not answer
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Recorded evidence blocks (14)
Q2
What did Upadacitinib's largest trial (2500 people) and its longest (13 years) measure?
2500 people in Upadacitinib's largest registered study, 13 years in its longest registered window, measuring Maximum Plasma Concentration (Cmax). ClinicalTrials.gov · 2026-09-01
45 phase3, 25 phase2, 18 na or unstated, 15 phase4, 8 phase1, 3 na, 1 early phase1; NCT03358693; 2029-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT05814627.
Interpretation These counts include studies where Upadacitinib 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
phase3
45
phase2
25
na or unstated
18
phase4
15
phase1
8
na
3
2 more recorded rows
early phase1
1
Last recorded human testNCT05814627
2026-07-15
recorded 2026-09-01 · last checked 2026-09-04
Q3
Upadacitinib was tested only in human — what did it show?
Interpretation Maximum Plasma Concentration (Cmax) — the recorded outcome words.
Show the evidence
humanNCT03646604
biomarker; Maximum Plasma Concentration (Cmax); 111
recorded 2026-09-01 · last checked 2026-09-04
Q4
5 of Upadacitinib's trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (2), funding/business (2) and other (1): Upadacitinib's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation."; 5 of 111 registered studies
Show the evidence
Trial
NCT03823378
terminated; "Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation."
NCT04666675
withdrawn; "Strategic considerations"
NCT06390722
withdrawn; "strategic decision"
NCT06773403
terminated; "There was not a big enough patient population to meet recruitment goals"
NCT06937788
terminated; "Recruitment targets (sample size) could not be met within the planned time frame."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Upadacitinib used Upadacitinib 15 MG — over how long?
4 recorded entries; human; also "Upadacitinib 15 MG", "Upadacitinib 15mg Dose", "Upadacitinib 30mg Dose"
Show the evidence
human
NCT06379958
Upadacitinib 15 MG
NCT06389136
Upadacitinib 15mg Dose
NCT06389136
Upadacitinib 30mg Dose
NCT06454188
Upadacitinib 15 MG [Rinvoq]
recorded 2026-09-01 · last checked 2026-09-04
Q6
Upadacitinib's half-life is 8 to 14 hours — which schedules were studied?
8 to 14 hours, the half-life Upadacitinib's label states. openfda-label · 2966aec7-2ef0-923c-d8ff-fe1a957bf095 · 2026-08-30
Show the evidence
half life
8 to 14 hours hours; Upadacitinib mean terminal elimination half-life ranged from 8 to 14 hours.
tmax
Absorption Following oral administration of RINVOQ extended-release tablets, upadacitinib is absorbed with a median T max of 2 to 4 hours.
metabolism
Elimination Metabolism Upadacitinib metabolism is mediated by mainly CYP3A4 with a potential minor contribution from CYP2D6.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 8th week endoscopic remission rate, achieving clinical remission based on das28 at week 12 and achieving clinical remission based on the cdai at week 12 did Upadacitinib's trials measure?
8th week endoscopic remission rate, achieving clinical remission based on das28 at week 12 and achieving clinical remission based on the cdai at week 12 lead 40 outcome terms across Upadacitinib's trials. ClinicalTrials.gov · 2026-09-01
electrocardiogram, an american college of rheumatology 20 response over time, an american college of rheumatology 50 response over time, an american college of rheumatology 70 response over time, an american college of rheumatology 20 response at week 12 and achieving clinical remission based on das28 at week 12 follow.
Show the evidence
number and percentage of adverse events
1
vital signs
1
clinical lab testing
1
electrocardiogram
1
an american college of rheumatology 20 response over time
1
an american college of rheumatology 50 response over time
1
14 more recorded rows
an american college of rheumatology 70 response over time
1
an american college of rheumatology 20 response at week 12
1
achieving clinical remission based on das28 at week 12
1
an american college of rheumatology 20 response at week 14
1
eczema area and severity index at week 16
1
disease activity 28 c reactive protein at week 12
1
sub study 1 percentage of endoscopic response
1
adverse events
1
endoscopic response at week 12
1
changes of molecular profiles over time
1
changes of molecular profiles associated treatment
1
changes of molecular profiles associated treatment response
1
maximum plasma concentration
1
time to maximum observed plasma concentration
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Upadacitinib's 55 ongoing trials reports first?
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12; Assessing Treatment-Emergent Adverse Events; latest 2034-12
Show the evidence
Trial
NCT02629159
"A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate"; n 1629; "Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12"; 2027-09-30
NCT03006068
"A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)"; n 950; "Assessing Treatment-Emergent Adverse Events"; 2027-07
NCT03345823
"A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433"; n 747; "Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)"; 2027-09
NCT03358693
"Molecular Signatures in Inflammatory Skin Disease"; n 300; "Changes of molecular profiles over time"; 2029-12-31
NCT03568318
"A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis"; n 1533; "Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16"; 2030-10-23
NCT03725007
"A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis"; n 124; "Treatment Emergent Adverse Events (TEAEs)"; 2029-03
14 further recorded trials
NCT04159597
"Expanded Access to Upadacitinib"
NCT04161898
"A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)"; n 56; "Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period"; 2028-08
NCT05094128
"A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting"; n 338; "Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1])"; 2027-04
NCT05305066
"Stand UP to Rheumatoid Arthritis (SUPRA)"; n 75; "Rate of recruitment at two RA referral centers over 12 months"; 2030-12
NCT05609630
"Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis."; n 90; "Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response"; 2029-06
NCT05674695
"Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy"; n 2500; "Rates of adverse events"; 2029-01-01
NCT05782907
"Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis."; n 122; "Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1)"; 2031-10
NCT05843643
"Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus"; n 1014; "Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response"; 2027-10
NCT05867329
"Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis"; n 700; "Adherence to intervention based on the proportion of participants who received the assigned Adaptive Treatment Strategy (ATS) (without receiving added/removed therapy outside of assignment) during first stage of therapy"; 2027-11
NCT05889182
"A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy"; n 1328; "Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 50"; 2028-09
NCT06012240
"A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata"; n 1500; "Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20"; 2030-04
NCT06016517
"Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis"; n 18; "Change in Disease Activity Score (DAS) 28"; 2028-12-15
NCT06095596
"Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis"; n 334; "8th-week endoscopic remission rate"; 2026-10-31
NCT06118411
"A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo"; n 614; "Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)"; 2028-03
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Upadacitinib could settle inflammatory markers?
NCT06873100 measures CRP variation, reading out 2026-12-31.
2 open trials; n 30; "Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis"
Show the evidence
Trial
NCT06873100
"Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis"; n 30; "CRP variation"; 2026-12-31
NCT06454188
"A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis"; n 100; "Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup"; 2028-10
Q10
Which 6 trials of Upadacitinib posted no result?
Posted no result
6 of 6 completed trials
Registrations
NCT01741493, NCT03661138, NCT06274996, NCT05989932, NCT05080218 and NCT03646604
Completion dates
oldest 2013-12; newest 2024-08-29
Show the evidence
Trial
NCT01741493
2013-12
NCT03661138
2022-08-19
NCT06274996
2023-12-31
NCT05989932
2024-04-19
NCT05080218
2024-05-28
NCT03646604
2024-08-29
Q11
At the median, Upadacitinib's trials enrolled 185 people — anything larger?
Median enrolment
185
Largest enrolment
2500
Registered trials counted
110
Q12
What do 721 spontaneous reports say about Upadacitinib — 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.
Upadacitinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 721 reaction mentions were counted: therapy interrupted 204; covid-19 110; urinary tract infection 92; herpes zoster 66. open-targets-adr · CHEMBL3622821 · 2026-06-24
Show the evidence
therapy interrupted
204
covid-19
110
urinary tract infection
92
herpes zoster
66
rheumatoid arthritis
58
infection
55
4 more recorded rows
illness
50
sinusitis
49
localised infection
24
sars-cov-2 test positive
13
recorded 2026-06-24 · last checked 2026-09-04
Q13
Upadacitinib and CYP2D6, CYP3A4 and CYP1A2: shared by which compounds?
CYP2D6, CYP3A4 and CYP1A2 appear in Upadacitinib's recorded interaction sentences, 21 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
In vitro studies indicate that upadacitinib induces CYP3A4 but does not induce CYP2B6 or CYP1A2 at clinically relevant concentrations.
pharmacokinetics
Following upadacitinib 30 mg and 45 mg tablets once daily, the effects on each CYP enzymes (CYP1A2, CYP3A, CYP2C9, and CYP2C19) were similar between two doses except for the effect on CYP2D6.
pharmacokinetics
Potential for Upadacitinib to Influence the Pharmacokinetics of Other Drugs In vitro studies indicate that upadacitinib does not inhibit the activity of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at clinically relevant concentrations.
CYP2B6
pharmacokinetics
In vitro studies indicate that upadacitinib induces CYP3A4 but does not induce CYP2B6 or CYP1A2 at clinically relevant concentrations.
pharmacokinetics
Potential for Upadacitinib to Influence the Pharmacokinetics of Other Drugs In vitro studies indicate that upadacitinib does not inhibit the activity of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at clinically relevant concentrations.
CYP2C19
pharmacokinetics
Following upadacitinib 30 mg and 45 mg tablets once daily, the effects on each CYP enzymes (CYP1A2, CYP3A, CYP2C9, and CYP2C19) were similar between two doses except for the effect on CYP2D6.
pharmacokinetics
Potential for Upadacitinib to Influence the Pharmacokinetics of Other Drugs In vitro studies indicate that upadacitinib does not inhibit the activity of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at clinically relevant concentrations.
CYP2C8pharmacokinetics
Potential for Upadacitinib to Influence the Pharmacokinetics of Other Drugs In vitro studies indicate that upadacitinib does not inhibit the activity of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at clinically relevant concentrations.
CYP2C9
pharmacokinetics
Following upadacitinib 30 mg and 45 mg tablets once daily, the effects on each CYP enzymes (CYP1A2, CYP3A, CYP2C9, and CYP2C19) were similar between two doses except for the effect on CYP2D6.
pharmacokinetics
Potential for Upadacitinib to Influence the Pharmacokinetics of Other Drugs In vitro studies indicate that upadacitinib does not inhibit the activity of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at clinically relevant concentrations.
CYP2D6
pharmacokinetics
Elimination Metabolism Upadacitinib metabolism is mediated by mainly CYP3A4 with a potential minor contribution from CYP2D6.
pharmacokinetics
Drug Interaction Studies Potential for Other Drugs to Influence the Pharmacokinetics of Upadacitinib Upadacitinib is metabolized in vitro by CYP3A4 with a minor contribution from CYP2D6.
pharmacokinetics
Following upadacitinib 30 mg and 45 mg tablets once daily, the effects on each CYP enzymes (CYP1A2, CYP3A, CYP2C9, and CYP2C19) were similar between two doses except for the effect on CYP2D6.
pharmacokinetics
CYP2D6 metabolic phenotype had no effect on upadacitinib pharmacokinetics (based on population pharmacokinetic analyses), indicating that inhibitors of CYP2D6 have no clinically relevant effect on upadacitinib exposures.
pharmacokinetics
Potential for Upadacitinib to Influence the Pharmacokinetics of Other Drugs In vitro studies indicate that upadacitinib does not inhibit the activity of cytochrome P450 (CYP) enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at clinically relevant concentrations.
pharmacokinetics
A weak inhibition of CYP2D6 was observed at upadacitinib 45 mg but not at 30 mg.
CYP3A4
pharmacokinetics
Elimination Metabolism Upadacitinib metabolism is mediated by mainly CYP3A4 with a potential minor contribution from CYP2D6.
pharmacokinetics
Drug Interaction Studies Potential for Other Drugs to Influence the Pharmacokinetics of Upadacitinib Upadacitinib is metabolized in vitro by CYP3A4 with a minor contribution from CYP2D6.
pharmacokinetics
In vitro studies indicate that upadacitinib induces CYP3A4 but does not induce CYP2B6 or CYP1A2 at clinically relevant concentrations.
pharmacokinetics
Following upadacitinib 30 mg and 45 mg tablets once daily, a weak induction of CYP3A4 was observed.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Upadacitinib studied with fasting?
fasting is named in Upadacitinib's label sentences: "In Study 1, using a randomized, two-sequence crossover design, a 3 mg dose of upadacitinib (immediate-release capsules) was administered alone under fasting conditions, after high-fat meal, or on Day 4 of a 6-day regimen of 400 mg once-daily ketoconazole." openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
In Study 1, using a randomized, two-sequence crossover design, a 3 mg dose of upadacitinib (immediate-release capsules) was administered alone under fasting conditions, after high-fat meal, or on Day 4 of a 6-day regimen of 400 mg once-daily ketoconazole.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Upadacitinib and mTOR?
"Combinations of Upadacitinib with either AZD8055 or Sapanisertib, mTORC1/C2 inhibitors, showed anti-proliferative effects against cytokine-dependent ATL cell lines and synergistic effect with reducing tumor growth in NSG mice bearing IL-2 transgenic tumors." — where Upadacitinib and mTOR appear together. Europe PMC · pathway abstract search · 2020-10-22
mTOR; PMID 33129109
Show the evidence
mTORPMID 33129109
"Combinations of Upadacitinib with either AZD8055 or Sapanisertib, mTORC1/C2 inhibitors, showed anti-proliferative effects against cytokine-dependent ATL cell lines and synergistic effect with reducing tumor growth in NSG mice bearing IL-2 transgenic tumors."
recorded 2020-10-22 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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