DAZAGAMGLOGENE AUTOGEDTEMCEL
UNII 2GNP7PE0CG

Substance Identification & Data

This profile provides standardized clinical and technical data for Dazagamglogene Autogedtemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 2GNP7PE0CG.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A 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

2GNP7PE0CG

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

DAZAGAMGLOGENE AUTOGEDTEMCEL

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

NCI Thesaurus

C203029

National Cancer Institute reference terminology for clinical and research data.

INN ID

12741

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Dazagamglogene Autogedtemcel

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

ITIS TSN

180092

Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.

NCBI Taxonomy

9606

Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

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

Dazagamglogene Autogedtemcel

Common Names & Synonyms

Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) collected by leukapheresis and genetically modified ex vivo by a pair of zinc finger nucleases (ZFN) directed against the genomic sequence of the erythroid-specific enhancer (ESE) located in the second intron of the B-cell lymphoma/leukemia 11A (BCL11A) gene on chromosome 2. The ZFN editing components comprise two messenger RNAs (mRNAs) with one mRNA encoding the left optimized ZFN (mRENH1), and the other mRNA encoding the right optimized ZFN (mRENH2). The two mRNAs are introduced ex vivo into the target cell population via electroporation. Subsequent endogenous non-homologous end joining DNA repair results in an insertion or deletion (indel) event thus permanently disrupting the BCL11A erythroid enhancer region. The cell suspension is enriched for CD34+ cells using magnetic bead separation and cultured in media containing Fms-related tyrosine kinase 3 ligand (Flt3L), stem cell factor (SCF), and thrombopoietin (TPO), prior to electroporation. The substance consists of cells with ≥80% CD34+ purity and detectable on-target editing

dazagamglogene autogedtemcel [INN]

External Clinical & Regulatory Resources

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