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Drug

Tofacitinib

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Xeljanz, Tasocitinib, Tofacitinibum.

1
Research papers
35
Active clinical trials
65
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

Tofacitinib: Suppressing Tumor Invasion in Recurrent GBM Patients

Clinical trial2026-06-29Results posted · ClinicalTrials.gov

Approval: TOFACITINIB (ANDA219370)

Regulatory2026-06-09FDA

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Achieves an ACR response in rheumatoid arthritis
59%Moderate confidence
Uncertainty ±18%Evidence coverage: PartialUpdated 30 June 2026

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence base is still thin.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tofacitinib
Aliases & brands
XeljanzTasocitinibTofacitinibum
RxNorm CUI
1357536
ChEMBL ID
CHEMBL221959
UNII
87LA6FU830
Regulatory jurisdictions
emamhrafda

Regulatory timeline

65 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2017-03-222018-05-30)
Earliest approval
2012-11-06
Latest approval
2026-06-09
Authorities
FDA · EMA · MHRA
Total events
65
fdaU.S. Food and Drug Administration· 61 events
2026-06-30Label change
Label change: TOFACITINIB (NDA213082)
Evidence ↗
2026-06-30Label change
Label change: TOFACITINIB (NDA208246)
Evidence ↗
2026-06-30Label change
Label change: TOFACITINIB (NDA203214)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2017-03-22ApprovalMulti-authority
Approval: Xeljanz (EMA)
Indication: Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients whoShow full indication

Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1). Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1). Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 3 events
2021-10-06Safety communicationSafety
Drug Safety Update: Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
Evidence ↗
2020-03-18Safety communicationSafety
Drug Safety Update: Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Evidence ↗
2019-05-17Safety communicationSafety
Drug Safety Update: Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

116 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
116
registered trials across all phases
LATEST COMPLETION 2025
35
Active studies
29
Recruiting
59
Late-stage (III+)
49
Completed
32
Discontinued
PHASE DISTRIBUTIONn = 116
Early Phase 14Phase 113Phase 1 / 24Phase 236Phase 2 / 33Phase 321Phase 427Phase N / A8

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • JCI insight1
Leading researchers
  • Cerise JE1
  • Chen JC1
  • Christiano AM1
  • Craiglow BG1
  • Jabbari A1
  • Kennedy Crispin M1
  • King BA1
  • Ko JM1
Leading institutions
free-text, unnormalised
  • Columbia University1
  • Stanford University School of Medicine1
  • Yale University School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.