Data updated: May 26, 2026
ENTYVIO (vedolizumab)
Integrin Receptor Antagonists
Trial Activity: Expansion 17 active trials
Immunology
Approved 2014-05-20
ENTYVIO is indicated for the treatment of Ulcerative Colitis; Crohn's Disease.
How ENTYVIO Works
Vedolizumab is a humanized monoclonal antibody that binds specifically to the α4β7 integrin found on certain memory T-lymphocytes. By binding to this integrin, the drug blocks its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1), a protein mainly expressed on gut endothelial cells. This blockade inhibits the migration of these inflammatory cells across the endothelium into gastrointestinal tissue. This targeted action helps reduce the chronic inflammation that characterizes both ulcerative colitis and Crohn's disease.
Development Insights
Takeda conducting 22 trials (39%)
74 indications explored (Broad Platform)
→ ulcerative colitis (16 trials)
→ crohn's disease (15 trials)
→ crohn disease (9 trials)
4
Indications
--
Phase 3 Trials
1
Priority Reviews
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2014-05-20
- Patent Cliff
- 2028
- Routes
- INJECTION, INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
ENTYVIO Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2014 to 2026 · 1 indication expansions
Jan 2023 SUPPL
Efficacy
What ENTYVIO Treats
2 indicationsENTYVIO is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
- Crohn's Disease
Source: FDA Label
ENTYVIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ENTYVIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENTYVIO treats. First-in-class if their pivotal trials read out positive.
Afimkibart RVT-3101 / PRA023
Hoffmann-La Roche TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials
Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials
Rocatinlimab AMG 451 / KHK4083 ✓ Won — Ph3 readout
Amgen TNFRSF4 · monoclonal antibody (anti-OX40, depleting) · 8 Phase 3 trials
Drugs Similar to ENTYVIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
56 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03196427 results posted | Vedolizumab-2005 2017-002182-21, U1111-1176-5741 | Ph 2 | completed | Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) |
| NCT06180382 VEDIAN | 23CH134 2023-508154-25-00 | Ph 4 | recruiting | Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration. |
| NCT04779307 results posted | MLN0002-3024 2020-004300-34, jRCT2071210030 | Ph 3 | completed | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) |
| NCT05205603 | 2021ZSLYEC-456 | Ph 4 | completed | Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis |
| NCT06095128 | Vedolizumab-4054 | Ph 4 | recruiting | A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) |
| NCT06045754 | Vedolizumab-4051 MACS-2022-120102, EXPLORER 2.0 | Ph 4 | recruiting | A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease |
| NCT06880744 REVAMP | M25-540 2024-518998-33-00 | Ph 3 | recruiting | A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab |
| NCT03819296 | 2018-0383 NCI-2018-03437, 2018-0383 | Ph 1 | recruiting | Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer |
| NCT06850727 | OD-07656-201 | Ph 2 | recruiting | Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis |
| NCT07398586 | SAHoWMU-CR2025-01-130 | Ph 4 | completed | The Association Between Interleukin-7 Receptor Gene Polymorphism and the Risk of Ulcerative Colitis |
| NCT06257706 VECTORS | TAK01769 | Ph 4 | recruiting | VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease |
| NCT06570772 | AVT16-GL-C01 | Ph 3 | terminated | Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio |
| NCT06646016 EPIC | MNK60052002 | Ph 2 | withdrawn | EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis |
| NCT04407247 | 2019-0276 NCI-2019-04986, 2019-0276 | Ph 1, Ph 2 | active not recruiting | Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma |
| NCT06317220 | 2024P000152 | Ph 2 | active not recruiting | Vedolizumab for the Treatment of Collagenous Gastritis |
| NCT03219359 | GCO 17-0378 | Ph 2 | recruiting | Autologous Stem Cell Transplant for Crohn's Disease |
| NCT06626165 | Geboes 3.2 | Ph 4 | completed | Association Between Effectiveness of Mirikizumab and UC Patients With High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa |
| NCT06443502 | Vedolizumab-3041 2023-504773-20-00 | Ph 3 | recruiting | A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis |
| NCT04738942 | Vedolizumab-3039 U1111-1262-7325, jRCT2031200371 | Ph 3 | active not recruiting | A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease |
| NCT05481619 | I20210001091 | Ph 4 | recruiting | Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis |
| NCT06815003 | 24473 NCI-2025-00341, 24473 | Ph 2 | recruiting | Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning |
| NCT06227910 VICTRIVA | Vedolizumab-3043 2023-509391-42-00 | Ph 3 | recruiting | A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease |
| NCT03629379 STRAUSS | S61472 | Ph 4 | completed | Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions |
| NCT06609447 | 2024-0602 | Ph 4 | recruiting | The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis |
| NCT06337695 | HREBA.CC-23-0271 | Ph 2, Ph 3 | not yet recruiting | VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer |
| NCT02723006 results posted | C28003 U1111-1177-4142, 2015-005554-35 | Ph 1 | terminated | Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma |
| NCT02743806 results posted | Vedolizumab-4013 2016-000678-40, U1111-1180-9339 | Ph 4 | terminated | Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease |
| NCT02764762 results posted | Vedolizumab-4006 U1111-1175-9094 | Ph 4 | completed | Triple Combination Therapy in High Risk Crohn's Disease (CD) |
| NCT02646683 LOVE-CD | 2014-100757 | Ph 4 | completed | A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study |
| NCT02768532 VEDO-PREDIRESP | 1608051 2016-001587-11 | Ph 4 | terminated | Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease |
| NCT03657160 results posted | Vedolizumab-3035 2018-002141-11, JapicCTI-184221 | Ph 3 | completed | Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation |
| NCT03558152 results posted | GA39925 2017-002350-36 | Ph 2 | completed | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC) |
| NCT00790933 GEMINI LTS results posted | C13008 2008-002784-14, NMRR-08-1040-2195 | Ph 3 | completed | An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease |
| NCT02790138 EARNEST results posted | Vedolizumab-4004 U1111-1171-0918, 2015-003472-78 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis |
| NCT02559713 results posted | Vedolizumab-4001 U1111-1171-5296 | Ph 4 | completed | Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease |
| NCT03138655 results posted | MLN0002-2003 2017-002231-41, U1111-1174-2041 | Ph 2 | completed | Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) |
| NCT02760615 | Vedolizumab-4002 U1111-1171-3187 | Ph 4 | withdrawn | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study |
| NCT02954159 COVET results posted | 2016-101742 | Ph 3 | terminated | Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC |
| NCT02834754 | PRO16030443 | Ph 2 | withdrawn | Vedolizumab Post Op Study |
| NCT02497469 results posted | MLN0002-3026 U1111-1168-6713, 2015-000939-33 | Ph 3 | completed | An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis |
| NCT02038920 results posted | MLN0002/CCT-001 U1111-1150-2688, JapicCTI-142402 | Ph 3 | completed | Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease |
| NCT02630966 ENTERPRISE results posted | Vedolizumab-4003 2015-000852-12, U1111-1174-2252 | Ph 4 | completed | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease |
| NCT03329209 results posted | Vedolizumab-1014 U1111-1197-3577 | Ph 1 | completed | A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants |
| NCT02728895 results posted | Vedolizumab-1015 U1111-1184-1822 | Ph 1 | completed | Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT |
| NCT03237260 | 825665 | Ph 4 | withdrawn | An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis |
| NCT02993783 results posted | Vedolizumab-2004 2016-002985-30, U1111-1185-6832 | Ph 2 | terminated | A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) |
| NCT02324699 results posted | GCO 14-2209 | Ph 4 | terminated | Corticosteroids With Vedolizumab in Crohn's Disease |
| NCT02039505 results posted | MLN0002/CCT-101 U1111-1151-6762, JapicCTI-142403 | Ph 3 | completed | Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis |
| NCT02929316 | IISR-2016-101481 | Ph 2 | terminated | Vedolizumab Induction May Prevent Celiac Enteritis |
| NCT02425111 results posted | MLN0002-3028 U1111-1159-5806, 2014-003509-13 | Ph 3 | completed | Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease |
Showing 50 of 56 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENTYVIO FDA Label Details
Indications & Usage
FDA Label (PDF)ENTYVIO is indicated for the treatment of Ulcerative Colitis; Crohn's Disease.
Read on TheraRadar
Entyvio: The Only IBD Drug That Stays in the Gut
Eleven years after approval, Entyvio remains the only IBD drug that acts only in the gut — and two large pharma programs have failed trying to replicate it.
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment