NDAORALTABLET
Approved
Nov 2012
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XELJANZ (tofacitinib) is an oral Janus kinase (JAK) inhibitor approved in 2012 for treating inflammatory conditions including rheumatoid arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. It works by selectively inhibiting JAK enzymes to reduce inflammatory signaling pathways. The drug represents a foundational small-molecule entry into the JAK inhibitor class, which has expanded significantly since its launch.
Post-LOEPost-LOE
Product is in post-loss-of-exclusivity phase with moderate competitive pressure (35/100), indicating smaller brand team and defensive positioning focused on retention and lifecycle management.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis
Started Apr 2025
3 enrolled
Atopic Dermatitis (AD)
Efficacy and Safety of Tofacitinib in Refractory Blau Syndrome
Started Oct 2024
30 enrolled
Blau Syndrome
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Started Jun 2024
65 enrolled
Ulcerative Colitis
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
Started May 2024
21,340 enrolled
Rheumatoid Arthritis
Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Started Apr 2024
10 enrolled
Psoriatic Arthritis, JuvenilePolyarticular Juvenile Idiopathic Arthritis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.