NDAORALSOLUTIONPriority Review
Approved
Sep 2020
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 14h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XELJANZ (tofacitinib) is an oral Janus kinase (JAK) inhibitor approved by the FDA in September 2020 as a solution formulation. It is indicated for rheumatoid arthritis and other inflammatory conditions, working by selectively inhibiting JAK enzymes to reduce immune-mediated inflammation. The drug represents a shift toward convenient oral dosing in a market historically dominated by injectable biologics.
$0.28BPart D
Post-LOEPost-LOEProduct is in late-stage maturity with ~$280M in annual Part D spending but faces significant competitive pressure (35% intensity); brand team will be defense-focused rather than growth-oriented.
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.