ZIIHERA (zanidatamab-hrii)
ZIIHERA is indicated for the treatment of Biliary Tract Cancer.
How ZIIHERA Works
Zanidatamab-hrii is a bispecific antibody that targets two separate extracellular sites on the HER2 receptor. Upon binding, the drug causes the receptor to be internalized, thereby reducing the density of HER2 on the surface of tumor cells. It further promotes tumor cell death by inducing immune-mediated responses, including complement-dependent cytotoxicity and antibody-dependent cellular phagocytosis. These mechanisms collectively inhibit tumor growth and lead to cell death in HER2-expressing cancers.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-11-20
- PDUFA Date
- 2026-08-25 (91d)
- Patent Cliff
- 2031
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZIIHERA Approval History
What ZIIHERA Treats
1 indicationsZIIHERA is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Biliary Tract Cancer
ZIIHERA Boxed Warning
EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . WARNING: EMBRYO‑FETAL TOXICITY See full prescribing information for complete boxed warning. • Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.1 )...
WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . WARNING: EMBRYO‑FETAL TOXICITY See full prescribing information for complete boxed warning. • Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.1 )
ZIIHERA Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
ZIIHERA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZIIHERA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZIIHERA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZIIHERA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06043427 | GA4 | Ph 2 | recruiting | Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma |
| NCT06282575 | JZP598-302 2023-508219-21-00 | Ph 3 | recruiting | Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer |
| NCT04164199 | BGB-A317-290-LTE1 2019-002554-23, 2023-508883-31-00 | Ph 3 | active not recruiting | Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies |
| NCT01042379 I-SPY | 097517 | Ph 2 | recruiting | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer |
| NCT06324357 | 1479-0012 | Ph 1, Ph 2 | recruiting | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread |
| NCT07102381 EmpowHER 208 | JZP598-208 2025-523204-68-00 | Ph 2 | recruiting | A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer |
| NCT07494448 JAZMINE | MEDOPP0776 2025-524613-89-00 | Ph 1, Ph 2 | not yet recruiting | Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer |
| NCT07405476 | 2025P012862 WINSHIP6609-25, NCI-2026-00566 | Ph 2 | recruiting | Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment |
| NCT05152147 HERIZON-GEA-01 | ZWI-ZW25-301 2021-000296-36, jRCT2061230026 | Ph 3 | active not recruiting | A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers |
| NCT06695845 | JZP598-206 2024-516551-41-00 | Ph 2 | recruiting | A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors |
| NCT07290985 AACR-ADOPT-GEA | AACR-ADOPT-GEA | Ph 2 | not yet recruiting | AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas |
| NCT06435429 | JZP598-303 2023-508960-31-00 | Ph 3 | recruiting | A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer |
| NCT07176312 ZANGEA | IKF/AIO-ZANGEA 2025-522718-22-00, AIO-STO-0425/ass | Ph 2 | recruiting | Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients |
| NCT07296705 HARBOR | HARBOR-II-2025 | Ph 2 | recruiting | Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC |
| NCT05035836 | 2021-0358 NCI-2021-09420 | Ph 2 | recruiting | A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) |
| NCT07192068 AcSé HER2 | UC-GMP-2505 2025-522169-31-00 | Ph 2 | recruiting | Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. |
| NCT07243938 | UNION-HER2-BASKET | Ph 2 | not yet recruiting | Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET) |
| NCT05027139 | ZWI-ZW25-204 | Ph 1, Ph 2 | completed | A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer |
| NCT05615818 SAFIR-ABC10 | UC-GMP-2201 - PRODIGE 78 2022-000190-19, 2022-502403-30-00 | Ph 3 | recruiting | Personalized Medicine for Advanced Biliary Cancer Patients |
| NCT05868226 PRE-I-SPY-PI | I-SPY-P1 | Ph 1 | recruiting | PRE-I-SPY Phase I/Ib Oncology Platform Program |
| NCT04276493 | BGB-A317-ZW25-101 CTR20210237 | Ph 1, Ph 2 | completed | Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZIIHERA FDA Label Details
Indications & Usage
FDA Label (PDF)ZIIHERA is indicated for the treatment of Biliary Tract Cancer.
WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . WARNING: EMBRYO‑FETAL TOXICITY ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment