CDEK
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enfortumab vedotin

Trade name: Padcev

mAbapprovedADCBreakthrough Therapy FDA

Approved

Dec 18, 2019

Enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate used for the treatment of urothelial cancer. It is a nectin-4-directed antibody and microtubule inhibitor conjugate. Enfortumab refers to the monoclonal antibody part, and vedotin refers to the payload drug (MMAE) and the linker. — Wikipedia

Clinical trial activity

61 trials · 55 clinical orgs · 2 marketing orgs

Phase 1
24
Phase 2
42
Phase 3
6
Phase 4
2

Earliest trial started Jun 1, 2011 (NCT01409135)

Timeline

2010s

  1. Jan 1, 2011

    Astellas — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2017

    Astellas — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2018

    Astellas — Earliest Phase 3 Sponsor(trial)

  4. Dec 8, 2019

    Astellas — First NDA Organization

  5. Dec 8, 2019

    Astellas — NDA Organization

  6. Dec 18, 2019

    Earliest FDA Approval

  7. Dec 18, 2019

    Astellas — Marketing Organization

  8. Dec 18, 2019

    Leo Pharma — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughDec 18, 2019

Chemistry & pharmacology

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

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • ags-22ce
  • ags-22m6e
  • ags-22m6e
  • ags-22me
  • asg-22ce
  • asg-22me
  • enfortumab vedotin
  • enfortumab vedotin
  • enfortumab vedotin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07221942Phase 2Jan 31, 2026Department of Defense, Temple University
NCT07232602Phase 1/Phase 2 (Phase 2)Dec 15, 2025Merck
NCT07287995Phase 1/Phase 2 (Phase 2)Dec 15, 2025Astellas
NCT07217496Phase 1Nov 30, 2025ImmunityBio, Inc., University of California, San Francisco
NCT07139977Phase 2Nov 1, 2025Astellas, Medical College of Wisconsin
NCT07183319Phase 2Oct 31, 2025Natera, Inc., University of Oklahoma
NCT07110038Phase 2Oct 31, 2025Astellas, IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, Institut für Klinische Krebsforschung IKF GmbH, Merck KGaA, University of Tuebingen
NCT07157956Phase 1/Phase 2 (Phase 2)Sep 10, 2025Convalife, Sun Yat-Sen University
NCT07087860Phase 2Aug 1, 2025Mayo Clinic
NCT06906822Phase 2Jun 10, 2025Astellas, Grupo Español Multidisciplinar de Melanoma, Merck, Universidad Complutense de Madrid
NCT06809140Phase 2Apr 30, 2025Astellas, Hoosier Cancer Research Network, Icahn School of Medicine at Mount Sinai, Merck, Seattle Genetics
NCT06862219Phase 4Mar 31, 2025Astellas, Pfizer
NCT06891560Phase 2Mar 31, 2025Astellas, Memorial Sloan-Kettering Cancer Center
NCT06781983Phase 1Jan 24, 2025Innate Pharma
NCT06764095Phase 4Jan 8, 2025Mayo Clinic
NCT06904573Phase 2Jan 1, 2025Sun Yat-Sen University
NCT06311214Phase 2Dec 20, 2024National Cancer Institute (NCI), University of Texas at Houston
NCT06302569Phase 2Nov 30, 2024University of Milan
NCT06493552Phase 2/Phase 3 (Phase 3)Nov 30, 2024University of Southern California, Vasgene Therapeutics, Inc
NCT06470282Phase 1/Phase 2 (Phase 2)Nov 30, 2024Astellas, Merck, University of California, San Francisco
Showing 20 of 61 trials
Page 1 / 4

Organizations

Research & Development (55)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstellasFor profit281252011
Seattle GeneticsFor profit18042011
MerckFor profit14522020
National Cancer Institute (NCI)Government4322021
Mayo ClinicAcademic/Hospital3322023
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital3312022
Agensys, Inc.For profit2112011
Emory UniversityAcademic/Hospital2222021
Harvard UniversityAcademic/Hospital2212021
Jordan UniversityAcademic/Hospital2012023
Sun Yat-Sen UniversityAcademic/Hospital2112025
Temple UniversityAcademic/Hospital2212023
University of California, San FranciscoAcademic/Hospital2222024
University of JordanAcademic/Hospital2212023
University of Texas at HoustonAcademic/Hospital2112024
ALX OncologyFor profit1112022
AstraZenecaFor profit1112021
ConvalifeFor profit1112025
Department of DefenseGovernment1012026
ExelixisFor profit1012021
55 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
AstellasFor profitMKTGDec 18, 2019
AstellasFor profitNDADec 8, 2019
Leo PharmaFor profitNDA2Dec 18, 2019