LABAFENOGENE MARSELECOBAC
UNII ABR4S53CKC

Substance Identification & Data

This profile provides standardized clinical and technical data for Labafenogene Marselecobac, uniquely identified by the FDA Unique Ingredient Identifier (UNII) ABR4S53CKC.

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

ABR4S53CKC

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

LABAFENOGENE MARSELECOBAC

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

NCI Thesaurus

C199064

National Cancer Institute reference terminology for clinical and research data.

INN ID

12595

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

MN-14

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 Labafenogene Marselecobac. 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

LABAFENOGENE MARSELECOBAC

Common Names & Synonyms

ENGINEERED BACTERIUM DERIVED FROM ESCHERICHIA COLI NISSLE 1917 (ECN) THAT HAS BEEN DESIGNED TO TREAT PHENYLKETONURIA (PKU) BY CONSUMING AND CONVERTING PHENYLALANINE (PHE) TO THE NONTOXIC METABOLITES TRANS-CINNAMIC ACID (TCA) AND PHENYLPYRUVATE (PP).

LABAFENOGENE MARSELECOBAC [INN]

LABAFENOGENE MARSELECOBAC [USAN]

RECOMBINANT LIVE ESCHERICHIA COLI STRAIN NISSLE 1917 (ECN) BACTERIA, GENETICALLY ENGINEERED AS FOLLOWS: A) INSERTION ACROSS THE GENOME OF FOUR COPIES OF A MODIFIED PHENYLALANINE AMMONIA LYASE (MPAL) GENE FROM PHOTORHABDUS LAUMONDII SUBSP. LAUMONDII WITH MUTATIONS S92G, H133M, I167K, L432I, V470A UNDER CONTROL OF THE LACI REPRESSOR/P TAC INDUCIBLE PROMOTER. B) INSERTION OF ONE EXTRA COPY OF THE ENDOGENOUS HIGH AFFINITY PHENYLALANINE SPECIFIC PERMEASE (PHEP), UNDER CONTROL OF THE LACI REPRESSOR/P TAC INDUCIBLE PROMOTER. C) INSERTION OF THE GENE L-AMINO ACID DEAMINASE (LAAD), DERIVED FROM PROTEUS MIRABILIS, UNDER CONTROL OF THE ENDOGENOUS ARAC TRANSCRIPTIONAL REGULATOR/P BAD INDUCIBLE PROMOTER. D) DELETION OF THE DAPA GENE, WHICH RENDERS BACTERIA CELLS AUXOTROPHIC UNLESS SUPPLEMENTED WITH DIAMINOPIMELATE (DAP) EXOGENOUSLY

Technical Codes

SYNB1934

SYNB-1934

External Clinical & Regulatory Resources

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