DIRLOCTOCOGENE SAMOPARVOVEC
UNII I2G2SZ8B0C

Substance Identification & Data

This profile provides standardized clinical and technical data for Dirloctocogene Samoparvovec, uniquely identified by the FDA Unique Ingredient Identifier (UNII) I2G2SZ8B0C.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2163074-23-3 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

I2G2SZ8B0C

CAS Registry Number

2163074-23-3

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

DIRLOCTOCOGENE SAMOPARVOVEC

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

NCI Thesaurus

C171795

National Cancer Institute reference terminology for clinical and research data.

INN ID

11154

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

JK-07

Identifier assigned by the United States Adopted Names Council.

Substance Type

structurallyDiverse

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Dirloctocogene Samoparvovec. 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

DIRLOCTOCOGENE SAMOPARVOVEC

Common Names & Synonyms

A RECOMBINANT NON-REPLICATING ADENO-ASSOCIATED VIRUS VECTOR WITH A BIO-ENGINEERED CAPSID DERIVED BY DNA SHUFFLING OF 10 AAV CAPSID SEQUENCES (AAV1, 2, 3B, 4, 5, 6 8, 9, AVIAN AND BOVINE AAV) FOLLOWED BY IN VIVOSELECTION IN FAH//RAG2//IL2RG/ (FRG) MICE PARTIALLY REPOPULATED WITH HUMAN HEPATOCYTES. THE VECTOR HAS AAV2 GENOMIC INVERTED TERMINAL REPEATS (ITR) AND ENCODES A HUMAN B-DOMAIN-DELETED BLOOD COAGULATION FACTOR VIII (HF8, FVIII) UNDER THE CONTROL OF A MODIFIED TRANSTHYRETIN (TTRM) PROMOTER

AAV-SPARK 200-HFVIII

DIRLOCTOCOGENE SAMOPARVOVEC [INN]

DIRLOCTOCOGENE SAMOPARVOVEC [USAN]

DIRLOCTOCOGENE SAMOPARVOVEC [WHO-DD]

DNA (RECOMBINANT ADENO-ASSOCIATED VIRUS 2 VECTOR AAVSPK200HFVIII8011 HUMAN B-DOMAIN-DELETED BLOOD-COAGULATION FACTOR VIII-SPECIFYING)