PRULACABTAGENE LEUCEL
UNII PA43J5W22U

Substance Identification & Data

This profile provides standardized clinical and technical data for Prulacabtagene Leucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) PA43J5W22U.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2762064-13-9 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

PA43J5W22U

CAS Registry Number

2762064-13-9

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

PRULACABTAGENE LEUCEL

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

NCI Thesaurus

C178424

National Cancer Institute reference terminology for clinical and research data.

INN ID

13570

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

LM-239

Identifier assigned by the United States Adopted Names Council.

Substance Type

structurallyDiverse

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 Prulacabtagene Leucel. 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

PRULACABTAGENE LEUCEL

Common Names & Synonyms

ADI-001 IS COMPOSED OF HEALTHY DONOR-DERIVED .GAMMA..DELTA. T CELLS ENRICHED FOR THE V.DELTA.1 .GAMMA..DELTA. T CELL SUBSET. IN ADDITION, ADI-001 IS DEMONSTRATED TO BE VIABLE, AS ASSESSED BY VIABLE DYE EXCLUSION, AND ARE DEPLETED OF RESIDUAL .ALPHA..BETA. T CELLS. ADI-001 CONTAINS CELLS THAT EXPRESS A CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING CD20 (MS4A1), A SURFACE ANTIGEN FOUND ON NON-MALIGNANT AND MALIGNANT B CELLS. THE CAR IS INTRODUCED VIA A GAMMA-RETROVIRAL VECTOR (AR3751) DURING THE MANUFACTURE OF THE CELLULAR ADI-001 DRUG SUBSTANCE. ADDITIONALLY, FOR INFORMATION ONLY, APPROXIMATELY 97.9% OF ADI-001 CELLS, ON AVERAGE, ARE ROUTINELY DEFINED BY MULTIPARAMETRIC FLOW CYTOMETRY TO IDENTIFY AND ENUMERATE MONOCYTES, B CELLS, NATURAL KILLER (NK) CELLS AND OTHER V.DELTA.1- CELLS INCLUDING V.DELTA.2 .GAMMA..DELTA. AND V.DELTA.1-V.DELTA.2- .GAMMA..DELTA. T CELLS.

PRULACABTAGENE LEUCEL [INN]

PRULACABTAGENE LEUCEL [USAN]