Entyvio
vedolizumab
APPROVED
Drug Profile
ModalityAntibody
RouteIV
Therapy AreaImmunology
Launch2014-05-20
US LOE2026-05-20
Peak Sales Est$7000M
Formulations[{"id":"entyvio-iv","route":"IV","setting":"INFUSION_CENTER","frequency":"Every 8 weeks (maintenance
Companies
TAK (ORIGINATOR)100%
Mechanism: Gut-selective α4β7 integrin inhibitor
Expert: Humanized monoclonal antibody that selectively binds α4β7 integrin, blocking gut-homing of T-lymphocytes without systemic immunosuppression.
Everyday: Blocks immune cells from entering the gut, reducing inflammation.
Targets: ["A4B7"]
Revenue History
| Period | Revenue ($M) |
|---|
| 2024 | $6,040M |
| Q1 2025 | $1,540M |
| Q2 2025 | $1,580M |
Programs (2)
| Indication | Stage | Key Study | Regional Status |
|---|
| UC | APPROVED | GEMINI 1 | [{"stage":"APPROVED","region":"US","approval_date":"2014-05-20"},{"stage":"APPRO |
| CD | APPROVED | GEMINI 2/3 | [{"stage":"APPROVED","region":"US","approval_date":"2014-05-20"},{"stage":"APPRO |
Notes
First gut-selective biologic for IBD. SC formulation launched 2020. Facing biosimilar competition in EU, US biosimilars expected 2026. Still growing in emerging markets.
Safety Profile
{"keyRisks":[{"category":"Infections","description":"Infections (generally lower systemic immunosuppression due to gut-selectivity)"},{"category":"Infusion Reactions","description":"Infusion-related reactions with IV formulation"},{"category":"PML","description":"Rare cases of progressive multifocal leukoencephalopathy"}],"monitoring":["Observe for neurological symptoms"],"labelSource":"FDA PI 2024","hasBoxedWarning":false,"contraindications":["Hypersensitivity to vedolizumab"]}
Data from Supabase · Updated 2026-03-24