AMTABAFUSP ALFA
UNII DYX4A3PAK8

Substance Identification & Data

This profile provides standardized clinical and technical data for Amtabafusp Alfa, uniquely identified by the FDA Unique Ingredient Identifier (UNII) DYX4A3PAK8.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2839531-84-7 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
DYX4A3PAK8
CAS Registry Number
2839531-84-7
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
AMTABAFUSP ALFA
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
C211766
National Cancer Institute reference terminology for clinical and research data.
INN ID
13207
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
NO-189
Identifier assigned by the United States Adopted Names Council.
Substance Type
Amtabafusp Alfa
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Amtabafusp Alfa. 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

Amtabafusp Alfa

Common Names & Synonyms

AMTABAFUSP ALFA [USAN]
Humanized immunoglobulin G1-lambda anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)] monomer disulfide bridged to human T-cell surface glycoprotein CD4 extracellular domain 1, engineered to bind human immunodeficiency virus gp120 envelope glycoprotein, fused to an Fc fragment of human immunoglobulin G1
Humanized immunoglobulin G1-lambda anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)] monomer disulfide bridged to human T-cell surface glycoprotein CD4 extracellular domain 1, engineered to bind human immunodeficiency virus gp120 envelope glycoprotein, fused to an Fc fragment of human immunoglobulin G1; gamma 1 heavy chain (1-445) [VH (Homo sapiens IGHV3-72*01 -(IGHD) -IGHJ4*01, CDR-Kabat [5.19.14] (31-35.50-68.101-114)) (1-125) -Homo sapiens IGHG1*03 (CH1 R222>K (126-223), hinge (224-238), CH2 L242>A, L243>A, P339>S (239-348), CH3 T374>S, L376>A, Y415>V, H443>R (349-453), CHS (454-455)) (126-455)], (228-214')-disulfide with lambda light chain (1'-215') [V-LAMBDA (Homo sapiens IGLV7-46*01 -IGLJ3*02, CDR-Kabat [14.7.9] (23'-36'.52'-58'.91'-99')) (1'-109') -Homo sapiens IGLC2*01 (110'-215')]; human T-cell surface glycoprotein CD4 extracellular domain 1 [mutant L5''>Y, S23''>N, A55''>V, I76''>P, L96''>V, F98''>V] (fragment 1''-99''), fused via a 100''GS101'' peptide linker to an Fc fragment of immunoglobulin 1 [Homo sapiens IGHG1*03, hinge (102''-111'', N-terminal EPKSC deleted), CH2 L115''>A, L116''>A, M133''>Y, S135''>T, T137''>E, P212''>S (112''-221''), CH3 T247''>W (222''-326''), CHS (327''-328'')) (102''-328'')]; heterodimer (234-107'', 237-110'')-bisdisulfide, produced in Chinese hamster ovary (CHO) cells, glycoform alfa
Immunoglobulin G1 Fab fragment [242-alanine,243-alanine,339-serine,374-serine,376-alanine,415-valine,443-arginine], anti-(human CD3 antigen ε-chain) (human-Mus musculus clone SP34 γ1-chain), disulfide with human-Mus musculus clone SP34 λ-chain, (Cys234→Cys107′),(Cys237→Cys110′)-bis(disulfide) with CD4 antigen (human extracellular domain D1) fusion protein with immunoglobulin G1 (human γ1-chain lower-hinge-CH2-CH3 region)
amtabafusp alfa [INN]

Technical Codes

GS-8588

External Clinical & Regulatory Resources

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