ROLDITAMIG
UNII P65E8F9MZV
Substance Identification & Data
This profile provides standardized clinical and technical data for Rolditamig, uniquely identified by the FDA Unique Ingredient Identifier (UNII) P65E8F9MZV.
Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 3038136-62-5 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.
P65E8F9MZV
3038136-62-5
N/A
Detailed Substance Profile
Preferred Name
ROLDITAMIG
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
National Cancer Institute reference terminology for clinical and research data.
INN ID
14031
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
Rolditamig
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Synonyms and Nomenclature
This section provides a complete list of nomenclature and identifier mappings for Rolditamig. 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
Rolditamig
Common Names & Synonyms
H-gamma1 heavy chain anti-ERBB2 domain 2 humanized hole (H) (1-449) [VH (Homo sapiens IGHV3-66*01 (78.8%) -(IGHD) -IGHJ4*01 (100%), CDR-IMGT [8.8.12] (26-33.51-58.97-108)) (1-119) -Homo sapiens IGHG1*03v, G1m3>G1m17, nG1m1 CH1 K120, CH3 E12, M14, 14-G1v33 CH3 S22, A24, V86 (hole), 14-G1v75 CH3 C5, 10-G1v83 CH3 R115, F116 (CH1 R120>K (216) (120-217), hinge 1-15 (218-232), CH2 (233-342), CH3 Y5>C (351), E12 (358), M14 (360), T22>S (368), L24>A (370), Y86>V (409), H115>R (437), Y116>F (438) (343-447), CHS (448-449)) (120-449)], (222-214')-disulfide with L-kappa light chain anti-ERBB2 domain 2 humanized (1'-214') [V-KAPPA (Homo sapiens IGKV1-16*01 (84.2%) -IGKJ1*01 (91.7%) L124>V (104'), CDR-IMGT [6.3.9] (27'-32'.50'-52'.89'-97')) (1'-107') - Homo sapiens IGKC*01 (100%) Km3 A45.1, V101 (C-KAPPA A45.1 (153'), V101 (191')) (108'-214')]; fused scFvhk-G1(h-CH2-CH3) heavy chain anti-ERBB2 domain 4 humanized knob (H'') (1''-480'') [scFvhk anti-ERBB2 domain 4 humanized (1''-247'') [VH (Homo sapiens IGHV3-66*01 (81.6%) -(IGHD) -IGHJ4*01 (100%), CDR-IMGT [8.8.13] (26''-33''.51''-58''.97''-109'')) (1''-120'') -20-mer tetrakis(tetraglycyl-seryl) linker (121''-140'') -V-KAPPA (Homo sapiens IGKV1-39*01 (86.3%) -IGKJ1*01 (100%), CDR-IMGT [6.3.9] (167''-172''.190''-192''.229''-237'')) (141''-247'') -1-mer (glycyl) linker (248'') -Homo sapiens IGHG1*03v h-CH2-CH3-CHS, nG1m1 CH3 E12, M14, 15-G1v37 h S5, 14-G1v74 CH3 C10, 14-G1v32 CH3 W22 (knob) (hinge 1-15 C5>S(253'') (249''-263''), CH2 (264''-373''), CH3 S10>C (387''), E12 (389''), M14 (391''), T22>W (399'') (374''-478''), CHS (479''-480'')) (249''-480'')]]; dimer (228-259'':231-262'':351-387'')-trisdisulfide, produced in a Chinese hamster ovary (CHO) cell line, lacking the enzyme alpha-(1,6)-fucosyltransferase (FUT8-KO), glycoform alfa
Immunoglobulin, anti-(human epidermal growth factor receptor HER2 extracellular domain 4) (human-Mus musculus monoclonal rhuMAb 2C4 single-chain variable fragment VH-(GGGGS)4-VL) fusion protein with immunoglobulin G1 [5-serine,139-cysteine,150-tryptophan] (human γ1-chain hinge-CH2-CH3 fragment), (259→228′),(262→231′),(387→351′)-tris(disulfide) with immunoglobulin G1 [216-lysine,351-cysteine,368-serine,370-alanine,409-valine,437-arginine,438-phenylalanine] anti-(human epidermal growth factor receptor HER2 extracellular domain 2) (human-Mus musculus monoclonal hum-Ab4D5-8 γ1-chain), (222′→214′′)-disulfide with (human-Mus musculus monoclonal hum-Ab4D5-8 κ-chain)
immunoglobulin (H-gamma1_L-kappa)_scFvhk-G1(h-CH2-CH3), anti-[Homo sapiens ERBB2 (receptor tyrosine-protein kinase erbB-2, epidermal growth factor receptor 2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340) extracellular domains 2 and 4], humanized monoclonal antibody, biparatopic (rolditamig)
rolditamig [INN]
