> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/zanidatamab-290ceeba-1188-42f7-8c41-3c32c24922eb > Record changed: 2026-10-13 # Zanidatamab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) ## Development status **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) **Drug name** Zanidatamab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) ### Brand names (2) - ziihera - Ziihera ### Other names (22) - anti her2 bi specific monoclonal antibody zw25 - ANTI-HER2 BI-SPECIFIC MONOCLONAL ANTIBODY ZW25 - jzp598 - JZP598 - tislelizumab zanidatamab - zanidatamab - Zanidatamab - zanidatamab \[INN\] - ZANIDATAMAB \[USAN\] - Zanidatamab \[WHO-DD\] - zanidatamab hrii - Zanidatamab hrii \[WHO-DD\] - zanidatamab hrii who dd - zanidatamab inn - zanidatamab usan - zanidatamab who dd - Zanidatamab-hrii - zw 25 - ZW-25 - zw25 - ZW25 - ZW25 (Zanidatamab) ## Identifiers **ATC classification codes** - L01FD07 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) **CAS registry numbers** - 2169946-15-8 **ChEMBL ID** CHEMBL4650256 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4650256) **FDA ingredient codes (UNII)** - Z20OC92TDI ### RxNorm IDs (RxCUI) (2) - 2698198 - 2698200 ## Regulatory information ### United States **Applicant** JAZZ PHARMS **Approval date** 20 Nov 2024 **Application number** BLA761416 ### European Union **Status** Authorised **Status date** 27 Jun 2025 **Authorisation date** 27 Jun 2025 **Approved indications** Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2). **Product number** EMEA/H/C/006380 **Authorisation holder** Jazz Pharmaceuticals Ireland Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** Yes **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Biliary Tract Neoplasms European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/ziihera) ### Other regulatory facts **Patents** 0 **Designations** 8 **Earliest recorded loss of exclusivity** 30 Jun 2035 **First in class** Yes **Fast track** Yes **Breakthrough designation** Yes **Orphan designation** Yes **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** zanidatamab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** Receptor protein-tyrosine kinase erbB-2 inhibitor **Action type** Inhibitor **Target** Receptor tyrosine-protein kinase erbB-2 **Protein identifier** P04626 ### Open Targets mechanisms - **Mechanism** Receptor protein-tyrosine kinase erbB-2 inhibitor **Action type** Inhibitor **Target** Receptor tyrosine-protein kinase erbB-2 ### Investigated indications (9) - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Breast Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0003869 **Subject identifier** D001943 - **Condition** Biliary Tract Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0003891 **Subject identifier** D001661 - **Condition** Hemangiosarcoma **Highest recorded phase** 2 **Condition identifier** EFO:0003968 **Subject identifier** D006394 - **Condition** Biliary Tract Neoplasms **Highest recorded phase** 4 **Condition identifier** HP:0100574 **Subject identifier** D001661 - **Condition** Stomach Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0001056 **Subject identifier** D013274 - **Condition** Biliary Tract Neoplasms **Highest recorded phase** 4 **Condition identifier** MONDO:0003060 **Subject identifier** D001661 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** MONDO:0004992 **Subject identifier** D009369 - **Condition** Breast Neoplasms **Highest recorded phase** 3 **Condition identifier** MONDO:0007254 **Subject identifier** D001943 ### Open Targets indications (23) - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0003891 - **Condition identifier** MONDO\_0001056 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002447 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002928 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0003060 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0003060 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0003219 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005028 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005036 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005089 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005304 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005411 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005575 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005627 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0006519 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0007254 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0007576 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0008170 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008903 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0011962 **Highest recorded phase** 2 ### Trial references (11) - NCT01042379 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01042379) - NCT04224272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04224272) - NCT05035836 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05035836) - NCT06435429 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06435429) - NCT02892123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02892123) - NCT04164199 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04164199) - NCT05027139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05027139) - NCT04466891 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04466891) - NCT06282575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06282575) - NCT05270889 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05270889) - NCT05615818 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05615818) ## Dosing **Dose** 20 mg/kg **Route** Intravenous **How often** Once every 2 weeks ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (6) - **Component** Glycosylation sites (N) **Sequence** Asn-300 $ Asn-332'''' - **Component** Heavy chain A **Type** Protein **Sequence** GEVQLVESGGGLVQPGGSLRLSCAASGFTFADYTMDWVRQAPGKGLEWVGDVNPNSGGSIYNQRFKGRFTFSVDRSKNTLYLQMNSLRAEDTAVYYCARNLGPSFYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYVYPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFALVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG - **Component** Heavy chain B **Type** Protein **Sequence** GDIQMTQSPSSLSASVGDRVTITCRASQDVNTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQPEDFATYYCQQHYTTPPTFGQGTKVEIKGGSGGGSGGGSGGGSGGGSGEVQLVESGGGLVQPGGSLRLSCAASGFNIKDTYIHWVRQAPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCSRWGGDGFYAMDYWGQGTLVTVSSAAEPKSSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYVLPPSRDELTKNQVSLLCLVKGFYPSDIAVEWESNGQPENNYLTWPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG - **Component** Light chain **Type** Protein **Sequence** GDIQMTQSPSSLSASVGDRVTITCKASQDVSIGVAWYQQKPGKAPKLLIYSASYRYTGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYYIYPATFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC - **Component** Glycosylation sites (N) **Sequence** Asn-300 $ Asn-332'' - **Component** Disulfide bridges **Sequence** 23-97 $ 24'-89' $ 24''-89'' $ 135'-195' $ 147-203 $ 150''-224'' $ 215'-223 $ 229-261'' $ 232-264'' $ 264-324 $ 296''-356' $ 370-428 $ 402''-460'' ## National Drug Codes - 68727-950 ## Related records ### Trials (34) - A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer - A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) - A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors - A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer - 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 - A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer - A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers - A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers - A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer - AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas - An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer - An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy - Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab - [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](https://trialight.com/data/trial/beamion-bcgc-1-a-study-to-find-a-suitable-dose-of-6cfde79b-909b-4f60-863a-38c1cbce4cb4.md) - Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene. - Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer - I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer - Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer - Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC - Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma ### Approved for (4) - [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) - [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) - Neoplasm ### In development for (5) - Angiosarcoma Phase 2 - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3 - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3 - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 2 - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) Phase 1 ### Targets (1) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) Receptor protein-tyrosine kinase erbB-2 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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