Xeljanz

Drug

Drug Profile

Xeljanz (tofacitinib) is an oral Janus kinase inhibitor used in selected inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular course juvenile idiopathic arthritis in defined populations. The U.S. label carries boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Initial U.S. approval was in 2012.

Drug Class
Janus kinase (JAK) inhibitor
Approval Status
FDA approved (Initial U.S. Approval: 2012; label updated through 2024)
Mechanism of Action
JAK-pathway inhibition (tofacitinib class mechanism).
Brand Names
  • XELJANZ
  • \XELJANZ XR\
Indications
  • \Moderately to severely active rheumatoid arthritis in adults with inadequate response or intolerance to one or more TNF blockers\
  • \Active psoriatic arthritis in adults with inadequate response or intolerance to one or more TNF blockers\
  • \Moderately to severely active ulcerative colitis in adults with inadequate response or intolerance to one or more TNF blockers\
  • \Active ankylosing spondylitis in adults with inadequate response or intolerance to one or more TNF blockers\
  • \Active polyarticular course juvenile idiopathic arthritis in patients 2 years and older\

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Related Clinical Trials

NCT ID Title Status Phase
NCT05754710

Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis

RECRUITING