Zanidatamab
Highest phase reached
Approved
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Zanidatamab
- ziihera
- Ziihera
- 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)
- ATC classification codes
- L01FD07
Sources for recorded values
- CAS registry numbers
- 2169946-15-8
- ChEMBL ID
- CHEMBL4650256
- FDA ingredient codes (UNII)
- Z20OC92TDI
- 2698198
- 2698200
- Applicant
- JAZZ PHARMS
- Approval date
- 20 Nov 2024
- Application number
- BLA761416
- 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
- 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 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
- 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
- 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
- NCT01042379
- NCT04224272
- NCT05035836
- NCT06435429
- NCT02892123
- NCT04164199
- NCT05027139
- NCT04466891
- NCT06282575
- NCT05270889
- NCT05615818
- Dose
- 20 mg/kg
- Route
- Intravenous
- How often
- Once every 2 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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''
- 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
- 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)
In development for (5)
- Angiosarcoma Phase 2
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Gastric cancer Phase 2
- Ovarian cancer Phase 1
Targets (1)
- ERBB2 Receptor protein-tyrosine kinase erbB-2 inhibitor