VENZUKITAGENE AUTOLEUCEL
UNII 292PQ4WUG2

Substance Identification & Data

This profile provides standardized clinical and technical data for Venzukitagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 292PQ4WUG2.

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

292PQ4WUG2

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

VENZUKITAGENE AUTOLEUCEL

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

INN ID

12926

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Venzukitagene Autoleucel

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 Venzukitagene Autoleucel. 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

Venzukitagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood, transduced with a non-replicating retroviral murine leukemia virus vector (MuLV) encoding a chimeric antigen receptor (CAR) consisting of modified interleukin 13 (IL-13) that binds preferentially the IL-13 receptor subunit α-2 chain (IL13RA2). The expressed transgene comprises a human immunoglobulin heavy chain signal peptide, mutated IL-13 (1-10>del, E21K, R74D, S77D, R117K), human CD8α hinge, human CD8α transmembrane domain, 4-1BB intracellular co-stimulatory domain and CD3ζ-signalling domain, under control of the intrinsic 5' long terminal repeat (LTR) promoter. The construct is flanked by 5' and 3' LTRs and also contains a MuLV packaging signal and a MuLV pol region. The peripheral blood mononuclear cells (PBMC) are selected and activated with anti-CD3 / anti-CD28 agonistic antibodies and proliferated in growth media containing interleukin 2 (IL-2). The cells are then transduced with the retroviral viral vector and further expanded in growth media containing IL-2. The cell suspension consists of CD3+ T lymphocytes (>95%), with ≥10% of the T lymphocytes expressing the IL-13 CAR transgene, with the proportion of CD3 negative cells that are CD20 positive being less than 3%.

venzukitagene autoleucel [INN]

External Clinical & Regulatory Resources

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