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Tofacitinib (Xeljanz) (tofacitinib-xeljanz)
Tofacitinib (Xeljanz) is a medication developed by Pfizer Inc. It works by inhibiting the activity of janus kinases (JAKs), specifically JAK1 and JAK3. This mechanism of action is key to its therapeutic effects in treating various inflammatory conditions. Tofacitinib is approved for use in rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ulcerative colitis, and atopic dermatitis. Its clinical differentiation lies in its ability to provide effective symptom relief with a favorable safety profile. The commercial significance of tofacitinib is evident in its significant revenue generation, with sales exceeding $7.3 billion. Pipeline developments for tofacitinib are focused on expanding its indications and improving its formulation.
At a glance
| Generic name | tofacitinib-xeljanz |
|---|---|
| Sponsor | Pfizer |
| Drug class | Janus Kinase Inhibitor |
| Target | JAK1 and JAK3 |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Rheumatoid Arthritis (RA)
- Psoriatic Arthritis (PsA)
- Polyarticular Juvenile Idiopathic Arthritis (pJIA)
- Ulcerative Colitis (UC)
- Atopic Dermatitis (AD)
Common side effects
- Herpes zoster
- Upper respiratory tract infection
- Nasopharyngitis
- Bronchitis
- Urinary tract infection
- Hepatic function abnormal
- Rheumatoid arthritis
- Hypertension
- Fall
- Upper respiratory tract inflammation
- Back pain
- Arthralgia
Drug interactions
- Warfarin
- P-glycoprotein inhibitors (e.g., cyclosporine, ketoconazole)
- P-glycoprotein inducers (e.g., rifampin, carbamazepine)
- Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine)
- Live vaccines
- Methotrexate
- Biologics (e.g., TNF inhibitors)
- Immunosuppressants (e.g., azathioprine)
- Narcotics
- Corticosteroids
Key clinical trials
- Korean Post-marketing Surveillance for Xeljanz XR
- Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease (PHASE2)
- Safety and Efficacy of Tofacitinib for Chronic Granulomatous Disease With Inflammatory Complications (PHASE1, PHASE2)
- The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea (NA)
- Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis (PHASE2, PHASE3)
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
- A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tofacitinib (Xeljanz) CI brief — competitive landscape report
- Tofacitinib (Xeljanz) updates RSS · CI watch RSS
- Pfizer portfolio CI