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← All drugs Report issue

Zanidatamab

mAbapprovedMulti-specificOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Nov 20, 2024

Clinical trial activity

24 trials · 30 clinical orgs · 1 marketing orgs

Phase 1
4
Phase 2
21
Phase 3
4
Phase 4
0

Earliest trial started Sep 1, 2016 (NCT02892123)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2019

    Earliest Phase 2 Sponsor(trial)

  3. Dec 18, 2019

    Orphan Drug Designation

2020s

  1. Jan 1, 2021

    Earliest Phase 3 Sponsor(trial)

  2. Nov 20, 2024

    Jazz Pharmaceuticals — Earliest FDA Approval

  3. Nov 20, 2024

    Jazz Pharmaceuticals — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackBreakthroughNov 20, 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

Also known as

  • zw25

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07290985Phase 2Mar 1, 2026American Association for Cancer Research, Jazz Pharmaceuticals
NCT07243938Phase 2Jan 15, 2026Huazhong University of Science and Technology
NCT07273981Phase 2Jan 1, 2026Xijing Hospital
NCT07176312Phase 2Oct 31, 2025IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest, Institut für Klinische Krebsforschung IKF GmbH, University of Hamburg
NCT07192068Phase 2Oct 30, 2025Institut Gustave Roussy, Jazz Pharmaceuticals, National Cancer Institute, France, UNICANCER
NCT07296705Phase 2Oct 25, 2025BeOne Medicines, Fujian Medical University
NCT07102381Phase 2Sep 24, 2025Jazz Pharmaceuticals
NCT06695845Phase 2Nov 29, 2024Jazz Pharmaceuticals
NCT06435429Phase 3Aug 13, 2024Jazz Pharmaceuticals
NCT06282575Phase 3Jul 19, 2024Jazz Pharmaceuticals
NCT05615818Phase 3Jul 18, 2024Accord Research, Belgian Group of Digestive Oncology, Cancer Research UK, Center Eugene Marquis, Institut Mutualiste Montsouris, National Cancer Institute, France, Otsuka, Pierre Fabre, Servier, UNICANCER, Université catholique de Louvain, University of London, Zymeworks Inc.
NCT06043427Phase 2Jan 15, 2024Canadian Cancer Trials Group, Jazz Pharmaceuticals, University of Toronto
NCT05868226Phase 1Dec 22, 2022QuantumLeap Healthcare Collaborative, University of Texas at Houston
NCT05270889Phase 2Apr 30, 2022Yonsei University
NCT05152147Phase 3Dec 31, 2021BeOne Medicines, Zymeworks Inc.
NCT05035836Phase 2Oct 15, 2021University of Texas at Houston, Zymeworks Inc.
NCT05027139Phase 1/Phase 2 (Phase 2)Sep 15, 2021ALX Oncology, Zymeworks Inc.
NCT04466891Phase 2Oct 1, 2020BeOne Medicines, Zymeworks Inc.
NCT04513665Phase 2Aug 12, 2020Memorial Sloan-Kettering Cancer Center, Zymeworks Inc.
NCT04276493Phase 1/Phase 2 (Phase 2)Mar 10, 2020BeOne Medicines
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (30)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Zymeworks Inc.For profit10742016
Jazz PharmaceuticalsFor profit7422024
BeOne MedicinesFor profit4122020
National Cancer Institute, FranceGovernment2022024
UNICANCERAcademic/Hospital2222024
University of Texas at HoustonAcademic/Hospital2122021
Accord ResearchFor profit1012024
ALX OncologyFor profit1012021
American Association for Cancer ResearchAcademic/Hospital1112026
Belgian Group of Digestive OncologyAcademic/Hospital1012024
Canadian Cancer Trials GroupAcademic/Hospital1112024
Cancer Research UKAcademic/Hospital1012024
Center Eugene MarquisAcademic/Hospital1012024
Fujian Medical UniversityAcademic/Hospital1112025
Huazhong University of Science and TechnologyAcademic/Hospital1112026
IKF Klinische Krebsforschung GmbH am Krankenhaus NordwestAcademic/Hospital1112025
Institut für Klinische Krebsforschung IKF GmbHAcademic/Hospital1012025
Institut Gustave RoussyAcademic/Hospital1012025
Institut Mutualiste MontsourisAcademic/Hospital1012024
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112020
30 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
Jazz PharmaceuticalsFor profitNDANov 20, 2024