Drug

Vedolizumab

Approved · EMA

Emerging researchLate-stage development

Also known as Entyvio.

RxNorm1538097UNII9RV78Q2002

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Clinical trial2026-08-03Results expected Q3 2027 · ClinicalTrials.gov

Early Concomitant Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

Clinical trial2026-07-22Results expected Q4 2027 · ClinicalTrials.gov

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)

Clinical trial2026-07-08Results expected Q2 2027 · ClinicalTrials.gov

An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Clinical trial2026-07-08Results expected Q3 2027 · ClinicalTrials.gov

Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation

Clinical trial2026-06-29Results expected Q4 2028 · ClinicalTrials.gov

CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)

Clinical trial2026-06-24Results expected Q2 2027 · ClinicalTrials.gov

An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W)

Clinical trial2026-06-15Results posted · ClinicalTrials.gov

PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety/Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)

Clinical trial2026-06-02Results expected Q4 2028 · ClinicalTrials.gov

Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study.

Research2019-02-26PloS one

Approval: Entyvio (EMA)

Regulatory2014-05-22EMA

Vedolizumab as induction and maintenance therapy for ulcerative colitis.

Research2013-08-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Vedolizumab

Aliases & brands

Entyvio

RxNorm CUI

1538097

UNII

9RV78Q2002

Regulatory jurisdictions

ema

Regulatory timeline

1 event

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.

Earliest approval

2014-05-22

Latest approval

2014-05-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2014-05-22Approval

Approval: Entyvio (EMA)

Indication: Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost… Show full indication

Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.