Zanidatamab
Ziihera (zanidatamab) is an antibody pharmaceutical. Zanidatamab was first approved as Ziihera on 2024-11-20. It is known to target receptor tyrosine-protein kinase erbB-2.
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FDA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Ziihera
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Zanidatamab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Ziihera | zanidatamab-hrii | Jazz Pharmaceuticals | N-761416 RX | 2024-11-20 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ziihera | Biologic Licensing Application | 2025-07-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary tract neoplasms | D001661 | — | C24.9 | — | 2 | 1 | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 1 | — | — | 4 |
| Adenocarcinoma | D000230 | — | — | — | 2 | 1 | — | — | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 2 | — | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 1 | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 1 | — | — | — | 1 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zanidatamab |
| INN | zanidatamab |
| Description | Zanidatamab is an antibody pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >8FFJ:I|Zanidatamab Heavy Chain B
GDIQMTQSPSSLSASVGDRVTITCRASQDVNTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQ
PEDFATYYCQQHYTTPPTFGQGTKVEIKGGSGGGSGGGSGGGSGGGSGEVQLVESGGGLVQPGGSLRLSCAASGFNIKDT
YIHWVRQAPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCSRWGGDGFYAMDYWGQ
GTLVTVSSAAEPKSSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVH
NAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYVLPPSRDELTKNQVSL
LCLVKGFYPSDIAVEWESNGQPENNYLTWPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSP
GGS
>8FFJ:J|Zanidatamab Heavy Chain A
GEVQLVESGGGLVQPGGSLRLSCAASGFTFTDYTMDWVRQAPGKGLEWVADVNPNSGGSIYNQRFKGRFTLSVDRSKNTL
YLQMNSLRAEDTAVYYCARNLGPSFYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS
WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGG
PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGK
EYKCKVSNKALPAPIEKTISKAKGQPREPQVYVYPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPV
LDSDGSFALVSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGGS
>8FFJ:Q|Zanidatamab Light Chain A
GDIQMTQSPSSLSASVGDRVTITCKASQDVSIGVAWYQQKPGKAPKLLIYSASYRYTGVPSRFSGSGSGTDFTLTISSLQ
PEDFATYYCQQYYIYPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS
QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGECGS
>8FFJ:X|Receptor tyrosine-protein kinase erbB-2
TQVCTGTDMKLRLPASPETHLDMLRHLYQGCQVVQGNLELTYLPTNASLSFLQDIQEVQGYVLIAHNQVRQVPLQRLRIV
RGTQLFEDNYALAVLDNGDPLNNTTPVTGASPGGLRELQLRSLTEILKGGVLIQRNPQLCYQDTILWKDIFHKNNQLALT
LIDTNRSRACHPCSPMCKGSRCWGESSEDCQSLTRTVCAGGCARCKGPLPTDCCHEQCAAGCTGPKHSDCLACLHFNHSG
ICELHCPALVTYNTDTFESMPNPEGRYTFGASCVTACPYNYLSTDVGSCTLVCPLHNQEVTAEDGTQRCEKCSKPCARVC
YGLGMEHLREVRAVTSANIQEFAGCKKIFGSLAFLPESFDGDPASNTAPLQPEQLQVFETLEEITGYLYISAWPDSLPDL
SVFQNLQVIRGRILHNGAYSLTLQGLGISWLGLRSLRELGSGLALIHHNTHLCFVHTVPWDQLFRNPHQALLHTANRPED
ECVGEGLACHQLCARGHCWGPGPTQCVNCSQFLRGQECVEECRVLQGLPREYVNARHCLPCHPECQPQNGSVTCFGPEAD
QCVACAHYKDPPFCVARCPSGVKPDLSYMPIWKFPDEEGACQPCPINCTHSCVDLDDKGCPA |
Identifiers
| PDB | 8FFJ |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650256 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15471 |
| UNII ID | Z20OC92TDI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Variants
No data
Financial
Revenue by drug
$
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£
â‚£
Ziihera – Jazz Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
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Additional graphs summarizing 433 documents
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Safety
Black-box Warning
Black-box warning for: Ziihera
Adverse Events
Top Adverse Reactions
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126 adverse events reported
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