GARETATUG REZETECAN
UNII FD5J5RLD4E

Substance Identification & Data

This profile provides standardized clinical and technical data for Garetatug Rezetecan, uniquely identified by the FDA Unique Ingredient Identifier (UNII) FD5J5RLD4E.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3023285-06-2 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

FD5J5RLD4E

CAS Registry Number

3023285-06-2

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

GARETATUG REZETECAN

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

NCI Thesaurus

C181025

National Cancer Institute reference terminology for clinical and research data.

INN ID

13530

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Garetatug Rezetecan

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

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Garetatug Rezetecan. 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

Garetatug Rezetecan

Common Names & Synonyms

H-gamma1 heavy chain humanized (1-448) [VH (Homo sapiens IGHV1-3*01 (87.8%) -(IGHD) -IGHJ4*01 (92.9%) L123>T (113), CDR-IMGT [8.8.11] (26-33.51-58.97-107)) (1-118) -Homo sapiens IGHG1*01 (100%) G1m17,1 CH1 K120, CH3 D12, L14 (CH1 K120 (215) (119-216), hinge 1-15 (217-231), CH2 (232-341), CH3 D12 (357), L14 (359) (342-446), CHS (447-448)) (119-448)], (221-220')-disulfide with L-kappa light chain humanized (1'-220') [V-KAPPA (Homo sapiens IGKV4-1*01 (90.1%) -IGKJ2*02 (100%), CDR-IMGT [12.3.9] (27'-38'.56'-58'.95'-103')) (1'-113') -Homo sapiens IGKC*01 (100%) Km3 A45.1, V101 (CKAPPA A45.1 (159'), V101 (197')) (114'-220')]; dimer (227-227'':230-230'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, cell line CHO-K1, glycoform alfa; substituted at the sulfur atoms of four L-cysteinyl residues on an average among 220', 220''', 221, 221'', 227, 227'', 230 and 230'' with (3RS)-1-[(2R,10S)-10-benzyl-2-cyclopropyl-1-{[(1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12Hbenzo[ de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl]amino}-1,6,9,12,15,18-hexaoxo-3-oxa-5,8,11,14,17-pentaazatricosan-23-yl]-2,5-dioxopyrrolidin-3-yl (rezetecan) groups

Immunoglobulin G1, anti-(human claudin-18 isoform A2) (human-Mus musculus monoclonal HRP00965 γ1-chain), disulfide with human-Mus musculus monoclonal HRP00965 κ-chain, dimer, reduced, tetrakis(thioether) with N-[6-(3-mercapto-2,5-dioxo-1-pyrrolidinyl)-1-oxohexyl]glycylglycyl-L-phenylalanyl-N-[[(1R)-1-cyclopropyl-2-[[(1S,9S)-9-ethyl-5-fluoro-2,3,9,10,13,15-hexahydro-9-hydroxy-4-methyl-10,13-dioxo-1H,12H-benzo[de]pyrano[3′,4′:6,7]indolizino[1,2-b]quinolin-1-yl]amino]-2-oxoethoxy]methyl]glycinamide

garetatug rezetecan [INN]

immunoglobulin G1-kappa, anti-[Homo sapiens CLDN18 (claudin 18, claudin-18, surfactant associated protein J, SFTPJ) isoform 2], humanized monoclonal antibody; conjugated on an average of four cysteinyl residues to rezetecan, comprising a linker and a camptothecin derivative (exatecan)

Technical Codes

SHRA1904

External Clinical & Regulatory Resources

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