zanidatamab-hrii 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antitumor, monoclonal antibodies 5841 None

Description:

MoleculeDescription

Molfile

Synonyms:

  • zanidatamab
  • zanidatamab-hrii
  • ziihera
  • ZW25
Zanidatamab-hrii is a humanized, IgG-like, bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 20, 2024 FDA Jazz Pharmaceuticals
June 27, 2025 EMA Jazz Pharmaceuticals Ireland Limited

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diarrhoea 61.82 59.03 24 52 460825 42160434

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diarrhoea 100.12 67.25 42 122 1139463 109449672

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FD07 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
FDA EPC N0000194137 Bispecific HER2-directed Antibody
FDA MoA N0000194138 HER2-directed Antibody Interactions
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FD HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors 5 drugs
margetuximabpertuzumabtrastuzumabtrastuzumab deruxtecantrastuzumab emtansine

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Unresectable or metastatic HER2-positive biliary tract cancer indication 363415003 DOID:4607




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Receptor tyrosine-protein kinase erbB-2 Kinase ANTIBODY BINDING Kd 9.13 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL4650256 ChEMBL_ID
DB15471 DRUGBANK_ID
4043591 VANDF
4043592 VANDF
C5966244 UMLSCUI
CHEBI:758162 CHEBI
2169946-15-8 SECONDARY_CAS_RN
390804 MMSL
43473 MMSL
d10233 MMSL
13627 IUPHAR_LIGAND_ID
10997 INN_ID
2698198 RXNORM
C000726995 MESH_SUPPLEMENTAL_RECORD_UI
D12011 KEGG_DRUG
Z20OC92TDI UNII
019929 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ZIIHERA HUMAN PRESCRIPTION DRUG LABEL 1 68727-950 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 26 sections