Upadacitinib
Approved · FDA / EMAAlso known as Rinvoq.
Recent clinical, regulatory, research and industry developments relating to this drug.
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Label change: UPADACITINIB (NDA211675)
Label change: UPADACITINIB (NDA218347)
Indication expansion: UPADACITINIB (NDA211675)
Label change: UPADACITINIB (NDA218347)
Evidence confidence
How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.
High point estimate, but substantial uncertainty remains.
Confidence has a low point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.
High point estimate, but substantial uncertainty remains.
Confidence has a moderate point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.
High point estimate, but substantial uncertainty remains.
Confidence has a moderate point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.
High point estimate, but substantial uncertainty remains.
— 6 supporting evidence families · 1 well-powered no-effect result
Confidence is moderated by well-powered no-effect evidence, despite broad trial support.
High point estimate, but substantial uncertainty remains.
Confidence has a moderate point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Rheumatoid arthritis Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are… Show full indicationShow less
Rheumatoid arthritis Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis Rinvoq is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitis Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn’s disease Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Utilization of a Cutaneous Therapy In Situ Microdevice
Recent completions
Trials that read out recently, adding to the completed evidence base.
Upadacetinib Versus MMF in SSc-ILD
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Journals, researchers & institutions
- The Journal of allergy and clinical immunology1
- Anderson JK1
- Beck LA1
- Gu Y1
- Guttman-Yassky E1
- Hong HC1
- Mohamed MF1
- Othman AA1
- Pangan AL1
- Clinical Pharmacology and Pharmacometrics1
- Icahn School of Medicine at Mount Sinai1
- Immunology Clinical Development1
- Institute and Comprehensive Center Inflammation Medicine1
- Institute for Health Services Research in Dermatology and Nursing1
- Probity Medical Research and K Papp Clinical Research1
- RxNorm (U.S. National Library of Medicine) — drug identity
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.