ETUVETIDIGENE AUTOTEMCEL
UNII SMN5E7TJ9C

Substance Identification & Data

This profile provides standardized clinical and technical data for Etuvetidigene Autotemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) SMN5E7TJ9C.

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

SMN5E7TJ9C

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ETUVETIDIGENE AUTOTEMCEL

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

NCI Thesaurus

C184832

National Cancer Institute reference terminology for clinical and research data.

INN ID

11283

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

NO-163

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 Etuvetidigene Autotemcel. 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

ETUVETIDIGENE AUTOTEMCEL

Common Names & Synonyms

AN AUTOLOGOUS CD34+ ENRICHED CELL POPULATION THAT CONTAINS CD34+ HSPC GENETICALLY MODIFIED EX VIVO USING A LENTIVIRAL VECTOR ENCODING THE HUMAN WAS GENE

AUTOLOGOUS CD34+ HEMATOPOIETIC STEM AND PROGENITOR CELLS (HSPC), OBTAINED FROM BONE MARROW OR MOBILISED PERIPHERAL BLOOD. THE CELLS ARE TRANSDUCED EX VIVO WITH A SELF-INACTIVATING (SIN), REPLICATION-INCOMPETENT HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) BASED LENTIVIRAL VECTOR ENCODING THE WISKOTT-ALDRICH SYNDROME (WAS) PROTEIN UNDER THE CONTROL OF THE HUMAN WAS GENE 1.6 KB PROMOTER, THE VECTOR IS PSEUDOTYPED WITH THE VESICULAR STOMATITIS VIRUS (VSV) ENVELOPE GLYCOPROTEIN. THE VECTOR GENOME ALSO CONTAINS A MUTATED WOODCHUCK HEPATITIS VIRUS POST-TRANSCRIPTIONAL REGULATORY ELEMENT (WPRE), A FRAGMENT OF THE HIV-1 GAG, THE HIV-1 REV RESPONSE ELEMENT (RRE), THE HIV-1 CENTRAL POLYPURINE TRACT (CPPT) AND A FRAGMENT OF NEF. THE CD34+ CELL POPULATION CORRESPONDS TO AN HETEROGENOUS POPULATION OF STEM AND PROGENITOR CELLS, SOME EXPRESSING THE CD90 AND/OR CD133 MARKER

ETUVETIDIGENE AUTOTEMCEL [INN]

ETUVETIDIGENE AUTOTEMCEL [USAN]

OTL 103 [WHO-DD]

OTL-103 (AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ HEMATOPOIETIC STEM AND PROGENITOR CELLS GENETICALLY MODIFIED EX VIVO USING A LENTIVIRAL VECTOR ENCODING THE HUMAN WISKOTT ALDRICH SYNDROME (WAS) CDNA SEQUENCE)