Tofacitinib clinical trials
Tofacitinib is named as an intervention in 29 current clinical trials in our China, Canada, Germany, France, USA, Netherlands, South Korea, Italy, Poland, Spain, UK, Belgium, Sweden, Japan, Australia, Israel, India, Czechia, Brazil and Singapore registers. 19 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Second Affiliated Hospital, Zhejiang University, School of Medicine (4). The most-studied condition is Rheumatoid Arthritis. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Tofacitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Tofacitinib was the US, on 6 Nov 2012. It is approved in 3 of the 3 regulators tracked here.
- 3 EU safety letters (DHPC), latest: referral - article 20 procedure for Cibinqo / Jyseleca / Olumiant / Rinvoq / Xeljanz, 21 Feb 2023
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tofacitinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tofacitinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 14 Sep 2034 (US 11253523, including a 6-month paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 21 Aug 2028.
- Exclusivity M-14: Other exclusivity: additional clinical trial information added to pediatric use subsection, until 21 Feb 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Tofacitinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tofacitinib works
All drug targets →- Janus Kinase (JAK) inhibitor InhibitorTarget: Janus Kinase (JAK)✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Takayasu arteritisPhase 3
- Acute respiratory distress syndromePhase 3
- Alopecia areataPhase 3
- Alopecia totalisPhase 3
- Alopecia universalis congenitaPhase 3
- Ankylosing spondylitisPhase 3
- Enthesitis-related juvenile idiopathic arthritisPhase 3
- GlioblastomaPhase 3
- Granulomatosis with polyangiitisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL221959, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5677, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tofacitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Tofacitinib. 5 are current, and 5 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tofacitinib for treating active ankylosing spondylitis NICE TA920 | Optimised | 18 Oct 2023 | Current |
| Tofacitinib for treating juvenile idiopathic arthritis NICE TA735 | Optimised | 20 Oct 2021 | Current |
| Tofacitinib for moderately to severely active ulcerative colitis NICE TA547 | Recommended | 28 Nov 2018 | Current |
| Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs NICE TA543 | Recommended | 3 Oct 2018 | Current |
| Tofacitinib for moderate to severe rheumatoid arthritis NICE TA480 | Optimised | 11 Oct 2017 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tofacitinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: XeljanzEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tofacitinib
- ATC code
- L04AA29
- ChEMBL
- CHEMBL221959
- DrugBank
- DB08895
- PubChem CID
- 9926791
- CAS number
- 477600-75-2
- FDA UNII
- 87LA6FU830
- Wikidata
- Q3530324
- Wikipedia
- Tofacitinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Tofacitinib
29 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Tofacitinib in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Tofacitinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Tofacitinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
8 single-substance products containing Tofacitinib on the HPRA medicines list.
- XELJANZ 1 mg/mL oral solutionPfizer Europe MA EEIG · EU/1/17/1178/015
- XELJANZ 10 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/17/1178/005-009
- XELJANZ 11 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/17/1178/010-013
- XELJANZ 5 mg film-coated tabletsPfizer Europe MA EEIG · EU/1/17/1178/001-003
- Tofacitinib STADA 10 mg film-coated tabletsStada Arzneimittel AG · PA0593/053/002 · Not marketed
Supply shortages
No entry for Tofacitinib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- Tofacitinib CitrateFDA · 19 Aug 2025 · Generic (ANDA) · Ajanta Pharma Ltd
Conditions studied with Tofacitinib
34 conditionsAll 34 conditions
| Condition (as registered) | Trials |
|---|---|
| Rheumatoid Arthritis | 4 |
| Ulcerative Colitis | 3 |
| Healthy Volunteers | 1 |
| Acute Severe Ulcerative Colitis | 1 |
| Thyroid Eye Disease, TED | 1 |
| Graves Ophthalmopathy | 1 |
| Graves Orbitopathy | 1 |
| Amyotrophic Lateral Sclerosis | 1 |
| Aneurysm | 1 |
| Behcet Syndrome, Vascular Type | 1 |
| Blau Syndrome | 1 |
| Hidradenitis Suppurativa | 1 |
| Dermatomyositis | 1 |
| Alopecia Areata | 1 |
| Janus Kinase Inhibitors | 1 |
| Palmoplantar Pustulosis (PPP) | 1 |
| Takayasu Arteritis | 1 |
| Erythematotelangiectatic Rosacea | 1 |
| Polyarticular Course Juvenile Idiopathic Arthritis (JIA) | 1 |
| Axial Spondyloarthritis | 1 |
| LAL | 1 |
| Rheumatoid Arthritis (RA | 1 |
| Granulomatosis With Polyangiitis | 1 |
| Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis | 1 |
| Juvenile Idiopathic Arthritis (JIA) | 1 |
| Ulcerative Colitis Acute | 1 |
| Nail Psoriasis | 1 |
| Active Moderate to Severe Rheumatoid Arthritis | 1 |
| Active Ankylosing Spondylitis | 1 |
| Active Psoriatic Arthritis | 1 |
| Ankylosing Spondylitis | 1 |
| Psoriatic Arthritis | 1 |
| Interstitial Lung Disease | 1 |
| Myositis | 1 |
Sponsors
lead sponsor per trial+ 10 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Tofacitinib trials
How many clinical trials are testing Tofacitinib?
29 current trials in our China, Canada, Germany, France, USA, Netherlands, South Korea, Italy, Poland, Spain, UK, Belgium, Sweden, Japan, Australia, Israel, India, Czechia, Brazil and Singapore registers name Tofacitinib (also registered as CP-690) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Tofacitinib trials recruiting patients?
Yes. 19 of the 29 trials are recruiting: 7 with sites in China, 2 with sites in Canada, 2 with sites in Germany, 2 with sites in France, 1 with sites in USA, 1 with sites in Netherlands, 3 with sites in South Korea, 1 with sites in Italy, 1 with sites in Spain and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tofacitinib clinical trials?
Second Affiliated Hospital, Zhejiang University, School of Medicine (4), Pfizer (2), Takeda (1) and AbbVie (1), among 25 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Tofacitinib licensed in Ireland?
Yes. The HPRA medicines list includes 8 single-substance products containing Tofacitinib, for example XELJANZ 1 mg/mL oral solution (Pfizer Europe MA EEIG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tofacitinib shortage?
Not in the lists we track: Tofacitinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tofacitinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tofacitinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tofacitinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.