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← All drugs Report issue

tarlatamab

Trade name: IMDELLTRA

mAbapprovedMulti-specificOrphan Drug FDABreakthrough Therapy FDA

Approved

May 16, 2024

Clinical trial activity

27 trials · 21 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
19
Phase 3
4
Phase 4
0

Earliest trial started Dec 26, 2017 (NCT03319940)

Timeline

2010s

  1. Jan 1, 2017

    Amgen — Earliest Phase 1 Sponsor(trial)

  2. Dec 27, 2018

    Orphan Drug Designation

2020s

  1. Jan 1, 2021

    Amgen — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2024

    Amgen — Earliest Phase 3 Sponsor(trial)

  3. May 16, 2024

    Amgen — Earliest FDA Approval

  4. May 16, 2024

    Amgen — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughMay 16, 2024

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07203053Phase 2May 31, 2026Amgen, Centre Leon Berard, ETOP IBCSG Partners Foundation
NCT07242547Phase 2Dec 25, 2025Fundación GECP, Grupo Español de Cáncer de Pulmón
NCT07243470Phase 1/Phase 2 (Phase 2)Nov 4, 2025Amgen, Centre Leon Berard, National Cancer Institute, France
NCT07037758Phase 1Sep 16, 2025Amgen, Asher Biotherapeutics, Inc.
NCT06893783Phase 2Sep 2, 2025Seoul National University, Sungkyunkwan University, University of Ulsan, Yonsei University
NCT06937905Phase 3Sep 1, 2025Intergroupe Francophone de Cancerologie Thoracique
NCT07061080Phase 2Aug 31, 2025Amgen, Grupo Espanol de Tumores Neuroendocrinos (GETNE), Universidad Autonoma de Barcelona
NCT07005128Phase 3Aug 18, 2025Amgen, AstraZeneca
NCT07111507Phase 2Jul 31, 2025Amgen, Memorial Sloan-Kettering Cancer Center
NCT07016230Phase 2Jul 2, 2025Amgen, Institut Gustave Roussy
NCT06814496Phase 1/Phase 2 (Phase 2)May 31, 2025Amgen, University of Arizona
NCT06898957Phase 1May 16, 2025Amgen
NCT06816394Phase 2May 15, 2025Amgen, National Taiwan University
NCT06830694Phase 2Apr 1, 2025Sungkyunkwan University
NCT06788938Phase 2Mar 21, 2025Amgen, University of California, Los Angeles
NCT06776250Phase 2Mar 3, 2025Amgen, University of Toronto
NCT06745323Phase 2Jan 29, 2025Amgen
NCT06598306Phase 1Oct 7, 2024Amgen
NCT06502977Phase 2Aug 27, 2024Amgen
NCT06211036Phase 3Jun 5, 2024Amgen
Showing 20 of 27 trials
Page 1 / 2

Organizations

Research & Development (21)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AmgenFor profit231442017
Centre Leon BerardAcademic/Hospital2112025
Sungkyunkwan UniversityAcademic/Hospital2112025
Asher Biotherapeutics, Inc.For profit1012025
AstraZenecaFor profit1012025
ETOP IBCSG Partners FoundationAcademic/Hospital1112026
Fundación GECPAcademic/Hospital1112025
Grupo Español de Cáncer de PulmónAcademic/Hospital1012025
Grupo Espanol de Tumores Neuroendocrinos (GETNE)Academic/Hospital1112025
Institut Gustave RoussyAcademic/Hospital1112025
Intergroupe Francophone de Cancerologie ThoraciqueAcademic/Hospital1112025
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112025
National Cancer Institute, FranceGovernment1012025
National Taiwan UniversityAcademic/Hospital1112025
Seoul National UniversityAcademic/Hospital1012025
Universidad Autonoma de BarcelonaAcademic/Hospital1012025
University of ArizonaAcademic/Hospital1112025
University of California, Los AngelesAcademic/Hospital1112025
University of TorontoAcademic/Hospital1112025
University of UlsanAcademic/Hospital1112025
21 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
AmgenFor profitNDAMay 16, 2024