GILAVEBEXAGENE ANVUPARVOVEC
UNII CUC7FB5YWE

Substance Identification & Data

This profile provides standardized clinical and technical data for Gilavebexagene Anvuparvovec, uniquely identified by the FDA Unique Ingredient Identifier (UNII) CUC7FB5YWE.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2364477-18-7 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
CUC7FB5YWE
CAS Registry Number
2364477-18-7
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
GILAVEBEXAGENE ANVUPARVOVEC
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
National Cancer Institute reference terminology for clinical and research data.
INN ID
12326
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
JK-189
Identifier assigned by the United States Adopted Names Council.
Substance Type
mixture
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Gilavebexagene Anvuparvovec. 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

GILAVEBEXAGENE ANVUPARVOVEC

Common Names & Synonyms

AXO-AAV-GM2 (RAAVRH8-HEXA/B) IS A ONE-TIME, ADENO-ASSOCIATED VIRUS (AAV) IN VIVO GENE THERAPY FOR THE TREATMENT OF TAY-SACHS AND SANDHOFF DISEASE. THE THERAPY IS DESIGNED TO PROVIDE A FUNCTIONAL COPY OF BOTH HEXA AND HEXB GENES THROUGH A 1:1 FORMULATION OF TWO MONOCISTRONIC VECTORS CARRYING EITHER GENE. EACH VECTOR UTILIZES A REPLICATION-DEFICIENT AAV SEROTYPE RH.8 (AAVRH.8) CAPSID CONTAINING A VIRAL GENOME CONSISTING OF AAV2 INVERTED TERMINAL REPEATS (ITRS), A CHICKEN .BETA.-ACTIN PROMOTER, A CHIMERIC CHICKEN .BETA.-ACTIN/RABBIT .BETA.-GLOBIN INTRON, THE HEXA OR HEXB CDNA TRANSGENE, AND A BOVINE GROWTH HORMONE POLYADENYLATION SIGNAL.
COBNABEXAGENE ANVUPARVOVEC
DNA (RECOMBINANT ADENO-ASSOCIATED VIRUS SEROTYPE RH.8 VECTOR AAVRH8-CB-CI-HEXB CHICKEN .BETA.-ACTIN PROMOTER/CHIMERIC CHICKEN .BETA.-ACTIN AND RABBIT .BETA.-GLOBIN INTRON/HUMAN .BETA.-ACETYLHEXOSAMINIDASE .BETA.-SUBUNIT TRANSGENE WTHEXB/SV40 POLYADENYLATION SIGNAL/BOVINE GROWTH HORMONE POLYADENYLATION SIGNAL PLUS ADENO-ASSOCIATED VIRUS SEROTYPE 2 INVERTED TERMINAL REPEAT FLANKS)
GILAVEBEXAGENE ANVUPARVOVEC [USAN]

Technical Codes

AXO-AAV-GM2