SIMOLADAGENE AUTOTEMCEL
UNII MOD3RG31RS

Substance Identification & Data

This profile provides standardized clinical and technical data for Simoladagene Autotemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) MOD3RG31RS.

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

MOD3RG31RS

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

SIMOLADAGENE AUTOTEMCEL

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

NCI Thesaurus

C171810

National Cancer Institute reference terminology for clinical and research data.

INN ID

11042

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

FG-30

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 Simoladagene 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

SIMOLADAGENE AUTOTEMCEL

Common Names & Synonyms

CELL BASED DRUG PRODUCT CONSISTING OF CELLS THAT HAVE BEEN GENETICALLY MODIFIED EX VIVO. IT INCLUDES AUTOLOGOUS CD34+ HEMATOPOIETIC STEM CELLS (HSCS) FROM SEVERE COMBINED IMMUNODEFICIENCY DUE TO ADENOSINE DEAMINASE DEFICIENCY (ADA-SCID) SUBJECTS TRANSDUCED EX VIVO WITH AN EF1AS LENTIVIRAL VECTOR (LV) THAT ENCODES FOR THE HUMAN ADENOSINE DEAMINASE (ADA) COMPLEMENTARY DEOXYRIBONUCLEIC ACID (CDNA) (EFS-ADA LV)

SIMOLADAGENE AUTOTEMCEL [INN]

SIMOLADAGENE AUTOTEMCEL [USAN]

SIMOLADAGENE AUTOTEMCEL [WHO-DD]

Technical Codes

OTL-101

External Clinical & Regulatory Resources

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