OZUNACOGENE PARVEC
UNII EJU2EQH9H4

Substance Identification & Data

This profile provides standardized clinical and technical data for Ozunacogene Parvec, uniquely identified by the FDA Unique Ingredient Identifier (UNII) EJU2EQH9H4.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3062583-60-9 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
EJU2EQH9H4
CAS Registry Number
3062583-60-9
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
OZUNACOGENE PARVEC
Official standardized name for this substance within the FDA UNII nomenclature system.
INN ID
13910
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 Ozunacogene Parvec. 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

OZUNACOGENE PARVEC

Common Names & Synonyms

OZUNACOGENE PARVEC [INN]
RECOMBINANT NON-REPLICATING BIDIRECTIONAL ADENO-ASSOCIATED VIRUS SEROTYPE 8 (RAAV8) VECTOR ENCODING TWO COPIES OF HUMAN COAGULATION FACTOR IX (FIX, F9) IN OPPOSITE TAIL-TO-TAIL ORIENTATION. EACH FIX TRANSGENE IS PRECEDED BY A MURINE ALBUMIN SPLICE ACCEPTOR TO ENSURE DNA INSERTION INTO INTRON 1 OF THE ALBUMIN (ALB) LOCUS WHEN ADMINISTERED IN ASSOCIATION WITH TAZIGURAN AND ZICLUMERAN. ONE FIX TRANSGENE IS TERMINATED WITH A SIMIAN VIRUS 40 (SV40) POLYADENYLATION SIGNAL AND ONE WITH A BOVINE GROWTH HORMONE POLYADENYLATION SIGNAL. BOTH TRANSGENES ARE CPG DEPLETED AND DO NOT ENCODE THE ENDOGENOUS FIX SIGNAL PEPTIDE. THE VECTOR GENOME IS FLANKED BY AAV2 INVERTED TERMINAL REPEATS (ITRS). FOLLOWING FACTOR IX (F9) DNA INSERTION INTO THE ALB LOCUS, THE TRANSCRIBED MESSENGER RNA CODES FOR A HYBRID PROTEIN WHICH INCLUDES THE ALB SIGNAL PEPTIDE AND F9 PRO-PEPTIDE SEQUENCES THAT ARE BOTH REMOVED DURING THE PROCESS OF F9 PROTEIN MATURATION, RESULTING IN WILD-TYPE HUMAN F9 PROTEIN

External Clinical & Regulatory Resources

CAS
Common Chemistry
NCATS
Inxight Drugs
NLM
DailyMed Products
NCATS
GSRS Full Record