Skip to main content

tofacitinib

Generic: TOFACITINIB CITRATE·Brand: TOFACITINIB CITRATE, XELJANZ, XELJANZ XR, Xeljanz

tofacitinib: developed by 1 company · 6 clinical trials tracked · 2 FDA decisions.

tofacitinib evidence translation

What we can confirm

2 FDA records · 6 tracked trials

What it means

Source-backed records connect tofacitinib to PFE; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could tofacitinib → PFE affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 3 study sponsors
Development Pipeline (2)
CompanyPhase
PFIZER INC (PFE)
Psoriatic Arthritis, Juvenile
Approved
PFIZER INC (PFE)
Psoriatic Arthritis, Juvenile
Approved
Clinical Trials (6)

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

NCT06654882·Phase 3·CDTX
Recruiting

Primary endpoint: Number of participants with MiDA

InterventionalRandomizedopen400 targetStarted 2026-01Completion 2026-124 sites · United StatesDuke University

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Disease Phase IIa Open-Label Clinical Trial and Associated Mechanistic Studies

NCT07281456·Phase 2·NRC
Recruiting

Primary endpoint: Number of Adverse Events by Grade/Category

Interventionalopen60 targetStarted 2025-12Completion 2030-121 site · United StatesNational Institute of Dental and Craniofacial Research (NIDCR)

An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

NCT06095128·Phase 4·TAK
Recruiting

Primary endpoint: Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score

Interventionalopen65 targetStarted 2024-06Completion 2027-0746 sites · Canada, United StatesTakeda

KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ® 5 MG FILM-COATED TABLETS AND XELJANZ® 1 MG/ML ORAL SOLUTION IN PATIENTS WITH ACTIVE PJIA AND JPSA

Recruiting

Primary endpoint: Number of patients with treatment emergent treatment-related adverse events

Observational10 targetStarted 2024-04Completion 2026-091 site · South KoreaPfizer

Tofacitinib: Suppressing Tumor Invasion in Recurrent GBM Patients

NCT05326464·Phase 3
Completed

Primary endpoint: Progression-free Survival (PFS) of the Study Cohort as Defined by RANO Criteria.

Interventionalopen18 enrolledStarted 2022-10Completion 2025-101 site · United StatesUniversity of Texas Southwestern Medical Center

OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

NCT04624230·Phase 3·PFE
Active, not recruiting

Primary endpoint: Remission by central read Mayo score following 44 weeks in the maintenance phase.

Interventionalopen118 enrolledStarted 2021-08Completion 2029-0650 sites · Australia, Belgium, Canada, Finland…Pfizer
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR 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. • Active ankylosing s(PFE)FDA ↗
NDA213082Type 3 - New Dosage FormPriorityOralSolution
Approval1 INDICATIONS AND USAGE XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR 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. • Active ankylosing s(PFE)FDA ↗
NDA208246Type 3 - New Dosage FormStandardOralTablet, Extended Release

Frequently asked questions

Who is developing tofacitinib?

tofacitinib is being developed by PFIZER INC.

How many clinical trials involve tofacitinib?

BioSniper tracks 6 clinical trials involving tofacitinib.

What is tofacitinib's latest FDA decision?

The most recent tracked FDA decision for tofacitinib is Approval for 1 INDICATIONS AND USAGE XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR 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. • Active ankylosing s, dated September 25, 2020.