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tofacitinib

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

tofacitinib: sourced relationships with 1 company · 7 clinical trials tracked · 2 FDA decisions.

tofacitinib evidence translation

What we can confirm

2 FDA records · 7 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 evidence5 indications · 1 study sponsors

Related indications

Psoriatic Arthritis, JuvenileGlioblastomaHealthy VolunteersSjogren's SyndromeUlcerative Colitis
Dated Pipeline Records (2)
CompanyDated record stage
PFIZER INC (PFE)
Reported 2016-02-23 · Current development: unknownSource
Psoriatic Arthritis, Juvenile
Approved
PFIZER INC (PFE)
Reported 2016-02-23 · Current development: unknownSource
Psoriatic Arthritis, Juvenile
Approved
Clinical Trial Registry Records (7)

A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers

NCT07843693Registry updated 2026-09-28·Phase 1·ABBV
Recruiting

Primary endpoint: Number of Participants With Treatment Emergent Adverse Events (TEAE)

Interventionalopen60 targetStarted 2026-08Completion 2026-121 site · United StatesAbbVie

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

NCT06654882Registry updated 2026-02-20·Phase 3
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

NCT07281456Registry updated 2026-10-02·Phase 2
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

NCT06095128Registry updated 2026-08-12·Phase 4
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

NCT05754710Registry updated 2026-08-03·PFE
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

NCT05326464Registry updated 2026-06-29·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

NCT04624230Registry updated 2026-08-03·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 spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. • Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with: • Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers. • Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use : • Use of XELJANZ/XELJANZ XR for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.1 , 1.2 , 1.3 , 1.4 ) • Use of XELJANZ tablets and XELJANZ XR for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.5 ) 1.1 Rheumatoid Arthritis XELJANZ tablets and XELJANZ XR (extended-release 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. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.2 Psoriatic Arthritis XELJANZ (tablets and oral solution) is indicated for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ XR (extended-release tablets) is indicated for the treatment of adults with active PsA who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ or XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.3 Ankylosing Spondylitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.4 Polyarticular Course Juvenile Idiopathic Arthritis XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with of active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.5 Ulcerative Colitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.(PFE)FDA ↗
NDA213082Type 3 - New Dosage FormPriorityOralSolution
Approval(PFE)FDA ↗
NDA208246Type 3 - New Dosage FormStandardOralTablet, Extended Release

Frequently asked questions

Which companies have sourced relationships with tofacitinib?

tofacitinib has dated SEC/FDA relationship records for PFIZER INC.

How many clinical trials involve tofacitinib?

BioSniper tracks 7 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 spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. • Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with: • Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers. • Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use : • Use of XELJANZ/XELJANZ XR for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.1 , 1.2 , 1.3 , 1.4 ) • Use of XELJANZ tablets and XELJANZ XR for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.5 ) 1.1 Rheumatoid Arthritis XELJANZ tablets and XELJANZ XR (extended-release 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. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.2 Psoriatic Arthritis XELJANZ (tablets and oral solution) is indicated for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ XR (extended-release tablets) is indicated for the treatment of adults with active PsA who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ or XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.3 Ankylosing Spondylitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.4 Polyarticular Course Juvenile Idiopathic Arthritis XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with of active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.5 Ulcerative Colitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended., dated September 25, 2020.