CDEK
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vedolizumab

Trade name: entyvio

mAbapprovedFast Track FDA

Approved

May 20, 2014

Vedolizumab, sold under the brand name Entyvio, is a monoclonal antibody medication developed by Takeda Oncology for the treatment of ulcerative colitis and Crohn's disease. It binds to integrin α4β7, blocking the α4β7 integrin results in gut-selective anti-inflammatory activity. — Wikipedia

Clinical trial activity

111 trials · 79 clinical orgs · 1 marketing orgs

Phase 1
19
Phase 2
55
Phase 3
31
Phase 4
33

Earliest trial started Feb 1, 2000 (NCT00655135)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. May 20, 2014

    Takeda — Earliest FDA Approval

  3. May 20, 2014

    Takeda — Marketing Organization

  4. May 20, 2014

    Takeda — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackMay 20, 2014

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • entyvio
  • entyvio
  • entyvio
  • entyvio
  • entyvio
  • ldp02
  • ldp-02
  • ldp-02
  • mln0002
  • mln0002
  • mln0002
  • mln-0002
  • mln02
  • mln-02
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab
  • vedolizumab

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06815003Phase 2Jan 8, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07248956Phase 2Nov 30, 2025Fudan University
NCT06788340Phase 4Sep 1, 2025University of Southern Denmark
NCT06841705Phase 2Jul 15, 2025Harvard University, Takeda
NCT06880744Phase 3Jun 17, 2025AbbVie
NCT06850727Phase 2Apr 30, 2025Odyssey Therapeutics
NCT06646016Phase 2Jan 31, 2025Mallinckrodt
NCT06581328Phase 4Jan 15, 2025Takeda
NCT06227910Phase 3Jan 8, 2025Takeda
NCT06405087Phase 3Dec 2, 2024Takeda
NCT06570772Phase 3Sep 30, 2024Alvotech
NCT06609447Phase 4Sep 21, 2024Zhejiang University
NCT06257706Phase 4Aug 7, 2024Robarts Clinical Trials, Takeda
NCT06100289Phase 3Jul 29, 2024Takeda
NCT06626165Phase 4Jul 20, 2024Showa Inan General Hospital
NCT06337695Phase 2/Phase 3 (Phase 3)Jul 1, 2024University of Calgary
NCT06443502Phase 3Jun 25, 2024Takeda
NCT06400719Phase 1May 29, 2024Alvotech
NCT06317220Phase 2May 1, 2024Harvard University, Takeda
NCT06180382Phase 4Feb 1, 2024University of Lyon
Showing 20 of 111 trials
Page 1 / 6

Organizations

Research & Development (79)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TakedaFor profit574252009
Millennium PharmaceuticalsFor profit101032000
National Cancer Institute (NCI)Government3022019
University of AmsterdamAcademic/Hospital3112015
Academisch Medisch CentrumAcademic/Hospital2212015
AlvotechFor profit2222024
Harvard UniversityAcademic/Hospital2212024
Icahn School of Medicine at Mount SinaiAcademic/Hospital2222016
Robarts Clinical TrialsFor profit2112023
Sun Yat-Sen UniversityAcademic/Hospital2222022
University of CalgaryAcademic/Hospital2222023
University of GroningenAcademic/Hospital2212019
University of LondonAcademic/Hospital2122019
University of LyonAcademic/Hospital2212016
University of Texas at HoustonAcademic/Hospital2222019
Zhejiang UniversityAcademic/Hospital2212021
AbbVieFor profit1112025
AGA Clinical Research Associates, LLCAcademic/Hospital1112016
AllerganFor profit1112018
Bnai Zion Medical CenterAcademic/Hospital1012017
79 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
TakedaFor profitMKTGMay 20, 2014
TakedaFor profitNDAMay 20, 2014