GAMSITABART
UNII Q9DX3HXD25

Substance Identification & Data

This profile provides standardized clinical and technical data for Gamsitabart, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Q9DX3HXD25.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3040339-17-8 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

Q9DX3HXD25

CAS Registry Number

3040339-17-8

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

GAMSITABART

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

INN ID

13908

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Gamsitabart

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

Synonyms and Nomenclature

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

Gamsitabart

Common Names & Synonyms

H-gamma1 heavy chain (1-441) [VH Musmus/Homsap (Mus musculus IGHV1-42*04 (86.5%) -(IGHD) -IGHJ4*01 (92.9%)/Homo sapiens IGHV1-46*01 (71.9%) -(IGHD) -IGHJ5*01 (90.9%) L123>S (108), CDR-IMGT [8.8.6] (26-33.51-58.97-102)) (1-113) -Homo sapiens IGHG1*03, G1m3, nG1m1 CH1 R120, CH3 E12, M14, 1-G1v50 CH2 delE1.4 P1.3, V1.2, A1.1, 5-G1v20 CH2 A105, 6-G1v60 CH2 S115, S116 (CH1 R120 (210) (114-211), hinge 1-15 (212-226), CH2 E1.4>del, L1.3>P (229), L1.2>V (230), G1.1>A (231), K105>A (317), A115>S (325), P116>S (326) (227-335), CH3 E12 (351), M14 (353) (336-440), CHS K2>del (441)) (114-441)], (216-220')-disulfide with L-kappa light chain (1'-220') [V-KAPPA Musmus/Homsap (Mus musculus IGKV1-110*01 (94.0%) -IGKJ5*01 (100%)/Homo sapiens IGKV2D-29*02 (82.0%) -IGKJ2*01 (81.8%) Q120>A (106'), I126>L (112'), CDR-IMGT [11.3.10] (27'-37'.55'-57'.94'-103')) (1'-113') -Homo sapiens IGKC*01 (100%) Km3 A45.1, V101 (C-KAPPA A45.1 (159'), V101 (197')) (114'-220')]; dimer (222-222'':225-225'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, cell line CHO-K1SV, glycoform alfa

Hu14.18-IgG1.4(K322A)-delK

Immunoglobulin G1 [233-proline,234-valine,235-alanine,322-alanine,330-serine,331-serine,de-C-terminal-lysine], anti-(ganglioside GD2) (human monoclonal MBE-91 γ1-chain), disulfide with human monoclonal MBE-91 κ-chain, dimer

gamsitabart [INN]

immunoglobulin G1-kappa, anti-[Homo sapiens GD2 (disialoganglioside GD2)], monoclonal antibody (gamsitabart)

Technical Codes

MBE-91

External Clinical & Regulatory Resources

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