TROCULEUCEL
UNII IZR558KO53

Substance Identification & Data

This profile provides standardized clinical and technical data for Troculeucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) IZR558KO53.

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

IZR558KO53

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TROCULEUCEL

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

NCI Thesaurus

C178330

National Cancer Institute reference terminology for clinical and research data.

INN ID

12720

Sequential identifier assigned via the WHO International Nonproprietary Name program.

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 Troculeucel. 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

TROCULEUCEL

Common Names & Synonyms

AUTOLOGOUS EX VIVO EXPANDED NATURAL KILLER CELLS

AUTOLOGOUS NATURAL KILLER (NK) CELLS ISOLATED FROM PERIPHERAL BLOOD LEUKAPHERESIS OF INDIVIDUAL HEALTHY DONORS. THE LEUKAPHERESIS MATERIAL IS ENRICHED FOR CD56+ CELLS BY POSITIVE IMMUNOSELECTION AND RE-SUSPENDED IN MEDIA CONTAINING FETAL BOVINE SERUM (FBS), INTERLEUKIN-2 (IL-2), AND INTERLEUKIN-21 (IL-21). THE CELLS ARE INITIALLY CULTURED IN MEDIA CONTAINING IL-2 AND TWO DIFFERENT IRRADIATED FEEDER CELL LINES AND THEN CULTURED WITH IL-2 ALONE TO INDUCE CELL EXPANSION. THE FINAL CELL POPULATION CONSISTS OF CD3-CD56+ NK CELLS (>=80%), WITH HIGHLY EXPRESSED ACTIVATING NK CELL RECEPTORS (NKP30, NKP44 AND NKP46, C-TYPE LECTIN-LIKE RECEPTOR (NKG2 FAMILY OF RECEPTORS INCLUDING NKG2C AND NKG2D)), AND OTHER ACTIVATING RECEPTORS SUCH AS CD16 AND CD244. THE CELLS ALSO UPREGULATE EXPRESSION OF PERFORIN-1, GRANZYME, TUMOR NECROSIS FACTOR ALPHA (TNF-.ALPHA.), INTERFERON GAMMA (IFN-.GAMMA.) AND CD107A, AND DEMONSTRATE CYTOTOXICITY AGAINST K562 MYELOID LEUKEMIA CELLS IN VITRO (>=50%)

AUTOLOGOUS NATURAL KILLER CELLS

NATURAL KILLER CELLS

NATURAL KILLER CELLS [WHO-DD]

NK CELLS, AUTOLOGOUS

TROCULEUCEL [INN]