AZAMIDUGENE AUTOTEMCEL
UNII 7BAL95SK9C

Substance Identification & Data

This profile provides standardized clinical and technical data for Azamidugene Autotemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 7BAL95SK9C.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A 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
7BAL95SK9C
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
AZAMIDUGENE AUTOTEMCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
C184823
National Cancer Institute reference terminology for clinical and research data.
INN ID
11773
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
OP-52
Identifier assigned by the United States Adopted Names Council.
Substance Type
structurallyDiverse
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
ITIS TSN
180092
Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.
NCBI Taxonomy
9606
Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Azamidugene Autotemcel. 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

AZAMIDUGENE AUTOTEMCEL

Common Names & Synonyms

AUTOLOGOUS CD34+ CELLS OBTAINED FROM MOBILISED PERIPHERAL BLOOD, TRANSDUCED WITH A SELF-INACTIVATING LENTIVIRAL VECTOR EXPRESSING HUMAN ALPHA-L-IDURONIDASE (IDUA) UNDER THE CONTROL OF A HUMAN PHOSPHOGLYCERATE KINASE (PGK) PROMOTER THE CONSTRUCT IS FLANKED BY 5' AND 3' LONG TERMINAL REPEATS (LTRS) AND ALSO CONTAINS A HIV-1 .PSI. PACKAGING SIGNAL, A REV RESPONSE ELEMENT (RRE), A CENTRAL POLYPURINE TRACT (CPPT) SEQUENCE AND THE WOODCHUCK HEPATITIS VIRUS POST-TRANSCRIPTIONAL REGULATORY ELEMENT (WPRE). THE VECTOR IS PSEUDOTYPED WITH THE ENVELOPE GLYCOPROTEIN (G) OF THE VESICULAR STOMATITIS VIRUS (VSV). THE CD34+ CELL POPULATION WAS ENRICHED USING IMMUNOMAGNETIC MICROBEADS, AND THE CELLS CULTURED IN THE PRESENCE OF MEDIA CONTAINING FMSRELATED TYROSINE KINASE 3 LIGAND (FLT-3L), INTERLEUKIN 3 (IL-3), THROMBOPOIETIN (TPO) AND STEM CELL FACTOR (SCF). THE FINAL SUBSTANCE CONTAINS 70% CD34+ CELLS
AUTOLOGOUS CD34+ CELLS OBTAINED FROM MOBILIZED PERIPHERAL BLOOD, TRANSDUCED WITH A SELF-INACTIVATING LENTIVIRAL VECTOR EXPRESSING HUMAN ALPHA-L-IDURONIDASE (IDUA) UNDER THE CONTROL OF A HUMAN PHOSPHOGLYCERATE KINASE (PGK) PROMOTER
AZAMIDUGENE AUTOTEMCEL [INN]
AZAMIDUGENE AUTOTEMCEL [USAN]

Technical Codes

OTL-203

External Clinical & Regulatory Resources

NCATS
Inxight Drugs
NLM
DailyMed Products
NCATS
GSRS Full Record
NIH
NCI Thesaurus