ZANIDATAMAB
UNII Z20OC92TDI

Substance Identification & Data

This profile provides standardized clinical and technical data for Zanidatamab, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Z20OC92TDI.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2169946-15-8 and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

Z20OC92TDI

CAS Registry Number

2169946-15-8

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ZANIDATAMAB

Official standardized name for this substance within the FDA UNII nomenclature system.

Molecular Formula

Z20OC92TDI

The specific atomic composition represented as a molecular structure string.

NCI Thesaurus

C130010

National Cancer Institute reference terminology for clinical and research data.

INN ID

10997

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

MN-268

Identifier assigned by the United States Adopted Names Council.

Substance Type

Zanidatamab

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Zanidatamab. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

Zanidatamab

Zanidatamab-HRII

Common Names & Synonyms

ANTI-HER2 BI-SPECIFIC MONOCLONAL ANTIBODY ZW25

ZANIDATAMAB [USAN]

Zanidatamab [WHO-DD]

Zanidatamab hrii [WHO-DD]

zanidatamab [INN]

Brand / Trade Names

ZIIHERA

Systematic Nomenclature

Immunoglobulin G1, anti-(human tyrosine kinase receptor HER2) (human-Mus musculus biparatopic monoclonal ZW25 light chain variable region fragment) fusion protein with peptide (synthetic 20-amino acid linker) fusion protein with human-Mus musculus biparatopic monoclonal ZW25 heavy chain variable region fragment fusion protein with peptide (synthetic 20-amino acid linker) fusion protein with human Fc fragment, (261→229'),(264→232')-bis(disulfide) with immunoglobulin G1 anti-(human tyrosine kinase receptor HER2) (human-Mus musculus biparatopic monoclonal ZW25 γ1-chain) disulfide with human-Mus musculus biparatopic monoclonal ZW25 κ-chain

SYS

Immunoglobulin G1-kappa, anti-[Homo sapiens ERBB2 (epidermal growth factor receptor 2, receptor tyrosine protein kinase erbB-2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340)], humanized monoclonal antibody, biparatopic (targeting two different non-overlapping epitopes on ERBB2); gamma1 heavy chain humanized (1-449) [VH (Homo sapiens IGHV3-66*01 (78.8%) -(IGHD) - IGHJ4*01 (100%)) [8.8.12] (1-120) -Homo sapiens IGHG1*01 G1m17,1 (CH1 K120 (217) (121-218), hinge 1-15 (219-233), CH2 (234-343), CH3 T6>V (353), L7>Y (354), D12 (359), L14 (361), F85.1>A (408), Y86>V (410) (344-448), CHS K2>del (449)) (121-449)], (223-215')-disulfide with kappa light chain humanized (1'-215') [V-KAPPA (Homo sapiens IGKV1-16*01 (84.2%) -IGKJ1*01 (100%)) [6.3.9] (1'-108') -Homo sapiens IGKC*01 (100%) Km3 A45.1 (154), V101 (192) (109'-215')]; gamma1 heavy chain V-KAPPA-VH-CH2-CH3 humanized (1''-481'') [V-KAPPA (Homo sapiens IGKV1-39*01 (86.3%) -IGKJ1*01 (100%)) [6.3.9] (1''-108'') -20-mer linker (109''-128'') -VH (Homo sapiens IGHV3-66*01 (81.6%) -(IGHD) -IGHJ4*01 (100%)) [8.8.13] (129''-248'') -dialanyl (249''-250'') -Homo sapiens IGHG1*01 (hinge 1-15, C5>S (255) (251-265), CH2 (266-375), CH3 T6>V (385), D12 (391), L14 (393), T22>L (401), K79>L (427), T81>W (429) (376-480), CHS K2>del (481)) (251''-481'')]; dimer (229-261'':232-264'')-bisdisulfide, produced in Chinese Hamster Ovary (CHO), glycoform alfa

SYS