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Zanidatamab · Ziihera, ZW-25

Bispecific antibody (Biparatopic) · Antagonist of HER2 extracellular domain 2 (ECD2) (ERBB2) · developed by Jazz Pharms

Approved FDA, Nov 2024

JAZZ Developer

4 Registered trials

What is Zanidatamab?

Zanidatamab-hrii is a bispecific antibody that binds two non-overlapping epitopes (ECD2 and ECD4) on HER2. It causes HER2 clustering, receptor internalization, and downregulation, inducing complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and antibody-dependent cellular phagocytosis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Ziihera, ZW-25, JZP598, ZIIHERA
Drug type: Bispecific antibody (Biparatopic)
Targets: HER2 extracellular domain 2 (ECD2) (ERBB2)
Mechanism: Antagonist of HER2 extracellular domain 2 (ECD2) (ERBB2)
Pathways: HER2 signaling inhibition, receptor internalization and downregulation
Therapy area: Oncology
Developer: Jazz Pharms (JAZZ)
Also in trials of: ZYME
FDA status: Approved as Ziihera (November 20, 2024), BLA761416 · FDA label
UNII: Z20OC92TDI

✅ FDA-approved uses

Gastroesophageal adenocarcinoma (HER2-positive, first-line, in combination with chemotherapy and tislelizumab)
Gastroesophageal adenocarcinoma (HER2-positive IHC 3+, first-line, in combination with chemotherapy)
Biliary tract cancer (HER2-positive IHC 3+, previously treated, unresectable or metastatic)

From the indications section of the FDA label (version of Aug 24, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT06282575	Phase 3	Biliary Tract Cancer	Recruiting	JAZZ
NCT05615818	Phase 3	Biliary Tract Neoplasms	Recruiting	ZYME
NCT04513665	Phase 2	Endometrial Cancer	Completed	ZYME
NCT04224272	Phase 2	HER2+/HR+ Breast Cancer	Completed	JAZZ

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Biliary Tract CancerBiliary Tract NeoplasmsCarcinosarcomaEndometrial CancerHER2+/HR+ Breast Cancer

Other drugs acting on ERBB2

Neratinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 ELVN-002 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1 TTX-MC138 Phase 1/2 Tuxobertinib Phase 1

More from Jazz Pharms

Asparaginase Erwinia chrysanthemi FDA approved Calcium, Magnesium, Potassium, And Sodium Oxybates FDA approved Daunorubicin And Cytarabine Liposome FDA approved Defibrotide FDA approved Lurbinectedin FDA approved CBD-OS Phase 3 Flezurafenib Phase 1 JZP269 Phase 1 JZP926 Phase 2/3 Nabiximols Phase 2 ONC206 Phase 2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the JAZZ page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z