AVALOTCAGENE ONTAPARVOVEC

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 04:55:11 GMT 2025` Edited by `admin` on `Wed Apr 02 04:55:11 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	RECOMBINANT VIRUS
Source Materials State	LIVE NON-REPLICATING GENETICALLY MODIFIED
Organism Family	Parvoviridae
Organism Genus	Dependoparvovirus
Organism Species	adeno-associated dependoparvovirus a
Infraspecific Type	RECOMBINANT VECTOR
Infraspecific Name	ADENO-ASSOCIATED VIRUS SEROTYPE 8 (AAV8) EXPRESSING THE HUMAN ORNITHINE TRANSCARBAMYLASE (OTC) PROTEIN-TBG/AMBP-head-to-head dimer
Part	whole
Record UNII	20E4R0BF12
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

AVALOTCAGENE ONTAPARVOVEC

Official Name

English

DTX-301

Preferred Name

English

A RECOMBINANT NON-REPLICATING ADENO-ASSOCIATED VIRUS TYPE 2/8 (RAAV REP2-CAP8) VECTOR, ENCODING CODON-OPTIMIZED, WILD-TYPE HUMAN ORNITHINE TRANSCARBAMYLASE (OTC) UNDER THE CONTROL OF A HYBRID HUMAN THYROXINE-BINDING GLOBULIN (TBG) / HUMAN ALPHA 1-MICROGL

Common Name

English

DTX-301 (ORNITHINE-TRANSCARBAMYLASE-GENE-THERAPY)

Common Name

English

DTX301

Code

English

avalotcagene ontaparvovec [INN]

Common Name

English

AVALOTCAGENE ONTAPARVOVEC [USAN]

Common Name

English

KFB12DX3PF

Code

English

SCAAV8OTC

Common Name

English

Code System Code Type Description

FDA UNII

20E4R0BF12