Rinvoq upadacitinib APPROVED
Drug Profile
ModalitySmall molecule
RouteORAL
Therapy AreaImmunology
Launch2019-08-16
US LOE2034-01-01
Peak Sales Est$12000M
Formulations[{"id":"rinvoq-po","doses":"15mg, 30mg, 45mg","route":"PO","setting":"OUTPATIENT","frequency":"Once
Companies
ABBV (ORIGINATOR)100%
Mechanism: JAK inhibitor
Expert: Janus kinase inhibitor that blocks JAK1/JAK2 signaling, inhibiting cytokine-driven inflammatory cascades. Oral small molecule alternative to biologics for autoimmune diseases.
Everyday: Blocks signals inside immune cells that cause inflammation. Used for arthritis and other autoimmune conditions.
Targets: ["JAK"]
Revenue History
PeriodRevenue ($M)
2024$5,986M
2025$8,304M
Q4 2025$2,330M
Programs (13)
IndicationStageKey StudyRegional Status
AAPHASE3UP-AA[]
GCAAPPROVEDSELECT-GCA[{"stage":"APPROVED","region":"US","approval_date":"2025-12-01"}]
HSPHASE3SELECT-HS[]
VitiligoFILEDViti-Up[]
RAAPPROVEDSELECT-COMPARE, SELECT-MONOTHERAPY[{"stage":"APPROVED","region":"US","approval_date":"2019-08-16"},{"stage":"APPRO
PsAAPPROVEDSELECT-PsA 1/2[{"stage":"APPROVED","region":"US","approval_date":"2021-12-14"},{"stage":"APPRO
ADAPPROVEDMeasure Up 1/2, AD Up[{"stage":"APPROVED","region":"US","approval_date":"2022-01-14"},{"stage":"APPRO
UCAPPROVEDU-ACHIEVE, U-ACCOMPLISH[{"stage":"APPROVED","region":"US","approval_date":"2022-03-16"},{"stage":"APPRO
CDAPPROVEDU-EXCEL, U-EXCEED[{"stage":"APPROVED","region":"US","approval_date":"2023-05-19"},{"stage":"APPRO
ASAPPROVEDSELECT-AXIS 1[{"stage":"APPROVED","region":"US","approval_date":"2022-06-06"},{"stage":"APPRO
SLEPHASE3SLE Ph3[]
Crohn's DiseaseAPPROVED[]
Crohn's DiseaseAPPROVED[]
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