Rinvoq
upadacitinib
APPROVED
Drug Profile
ModalitySmall molecule
RouteORAL
Therapy AreaImmunology
Launch2019-08-16
US LOE2034-01-01
Peak Sales Est$12000M
Formulations[{"id":"rinvoq-po","doses":"15mg, 30mg, 45mg","route":"PO","setting":"OUTPATIENT","frequency":"Once
Mechanism: JAK inhibitor
Expert: Janus kinase inhibitor that blocks JAK1/JAK2 signaling, inhibiting cytokine-driven inflammatory cascades. Oral small molecule alternative to biologics for autoimmune diseases.
Everyday: Blocks signals inside immune cells that cause inflammation. Used for arthritis and other autoimmune conditions.
Targets: ["JAK"]
Revenue History
| Period | Revenue ($M) |
|---|
| 2024 | $5,986M |
| 2025 | $8,304M |
| Q4 2025 | $2,330M |
Programs (13)
| Indication | Stage | Key Study | Regional Status |
|---|
| AA | PHASE3 | UP-AA | [] |
| GCA | APPROVED | SELECT-GCA | [{"stage":"APPROVED","region":"US","approval_date":"2025-12-01"}] |
| HS | PHASE3 | SELECT-HS | [] |
| Vitiligo | FILED | Viti-Up | [] |
| RA | APPROVED | SELECT-COMPARE, SELECT-MONOTHERAPY | [{"stage":"APPROVED","region":"US","approval_date":"2019-08-16"},{"stage":"APPRO |
| PsA | APPROVED | SELECT-PsA 1/2 | [{"stage":"APPROVED","region":"US","approval_date":"2021-12-14"},{"stage":"APPRO |
| AD | APPROVED | Measure Up 1/2, AD Up | [{"stage":"APPROVED","region":"US","approval_date":"2022-01-14"},{"stage":"APPRO |
| UC | APPROVED | U-ACHIEVE, U-ACCOMPLISH | [{"stage":"APPROVED","region":"US","approval_date":"2022-03-16"},{"stage":"APPRO |
| CD | APPROVED | U-EXCEL, U-EXCEED | [{"stage":"APPROVED","region":"US","approval_date":"2023-05-19"},{"stage":"APPRO |
| AS | APPROVED | SELECT-AXIS 1 | [{"stage":"APPROVED","region":"US","approval_date":"2022-06-06"},{"stage":"APPRO |
| SLE | PHASE3 | SLE Ph3 | [] |
| Crohn's Disease | APPROVED | — | [] |
| Crohn's Disease | APPROVED | — | [] |
Upcoming Catalysts (5)
Rinvoq - Vitiligo - FDA Approval
2026
Rinvoq - GCA - FDA Approval
2026
Rinvoq - Alopecia Areata - Ph3 - Data (UP-AA)
2026
Rinvoq - HS - Ph3 - Data
2026
Rinvoq - SLE - Ph3 - Data
2026
Notes
Selective JAK1 inhibitor. 9 approved indications in US (RA, PsA, AD, UC, CD, AS, axSpA, nr-axSpA, GCA). 2025 revenue $8.3B (+39% YoY). Expanding into vitiligo, AA, HS, SLE.
Safety Profile
{"keyRisks":[{"category":"Infections","description":"Serious infections, herpes zoster"},{"category":"Malignancy","description":"Lymphoma and other malignancies"},{"category":"Cardiovascular","description":"MACE, VTE/PE"},{"category":"Hepatic","description":"Hepatic disorders"},{"category":"Hematologic","description":"Neutropenia (30mg)"}],"monitoring":["CBC","LFTs","Lipids"],"labelSource":"FDA PI 2024","hasBoxedWarning":true,"boxedWarningText":"Serious infections, mortality, malignancies, MACE, VTE/PE, GI perforations","boxedWarningCategories":["Infections","Malignancy","Cardiovascular","Thrombosis"]}
Data from Supabase · Updated 2026-03-24