DALNACOGENE PONPARVOVEC
UNII XHE4MDR8C6

Substance Identification & Data

This profile provides standardized clinical and technical data for Dalnacogene Ponparvovec, uniquely identified by the FDA Unique Ingredient Identifier (UNII) XHE4MDR8C6.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2770683-67-3 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

XHE4MDR8C6

CAS Registry Number

2770683-67-3

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

DALNACOGENE PONPARVOVEC

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

NCI Thesaurus

C211819

National Cancer Institute reference terminology for clinical and research data.

INN ID

12774

Sequential identifier assigned via the WHO International Nonproprietary Name program.

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 Dalnacogene Ponparvovec. 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

DALNACOGENE PONPARVOVEC

Common Names & Synonyms

DALNACOGENE PONPARVOVEC [INN]

DNA (RECOMBINANT REPLICATION-DEFECTIVE ADENO-ASSOCIATED VIRUS 2 VECTOR RECOMBINANT LIVER-SPECIFIC PROMOTER LXP2.1 PLUS HUMAN DNA-DEPENDENT RNA POLYMERASE II GENE INTRON 1 PLUS HUMAN BLOOD-COAGULATION FACTOR IX PADUA CODON-OPTIMIZED GENE 5'-REGION PLUS HUMAN IMMUNOGLOBULIN HEAVY CHAIN VARIABLE REGION GENE INTRON 2 PLUS HUMAN BLOOD-COAGULATION FACTOR IX PADUA CODON-OPTIMIZED GENE 3'-REGION PLUS RECOMBINANT MINI POLYADENYLATION SIGNAL PLUS ADENO-ASSOCIATED VIRUS 2 INVERTED TERMINAL REPEAT FLANKS-SPECIFYING)

RAAV843 VECTOR

RECOMBINANT, SELF-COMPLEMENTARY, NON-REPLICATING ADENOASSOCIATED VIRUS, SYNTHETIC LIVER-TROPIC SEROTYPE 843 (RAAV843) VECTOR, ENCODING A CODON-OPTIMISED (CPG REDUCED) GAIN OF FUNCTION VARIANT (PADUA VARIANT; R338L) OF HUMAN COAGULATION FACTOR IX (FIX), UNDER CONTROL OF A SYNTHETIC LIVER-SPECIFIC LXP2.1 PROMOTER AND A SYNTHETIC POLYADENYLATION (POLYA) SEQUENCE DERIVED FROM THE RABBIT BETA-GLOBIN GENE POLYA SIGNAL. THE EXPRESSION CASSETTE ALSO CONTAINS A HUMAN DNA-DEPENDENT RNA POLYMERASE II GENE INTRON, A KOZAK SEQUENCE, A HUMAN IMMUNOGLOBULIN HEAVY CHAIN VARIABLE REGION GENE INTRON INSERTED INTO THE MIDDLE OF THE FIX CODING REGION, AND AN ENHANCER DERIVED FROM THE PROMOTER REGION OF HUMAN ALPHA-1-ANTITRYPSIN. THE TRANSGENE IS FLANKED BY ADENOASSOCIATED VIRUS 2 (AAV2) INVERTED TERMINAL REPEATS (ITRS)

External Clinical & Regulatory Resources

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