ZIMISLECEL
UNII 4FBM3KR723
Substance Identification & Data
This profile provides standardized clinical and technical data for Zimislecel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 4FBM3KR723.
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.
4FBM3KR723
N/A
N/A
Detailed Substance Profile
Preferred Name
ZIMISLECEL
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
12529
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
NO-24
Identifier assigned by the United States Adopted Names Council.
Substance Type
Zimislecel
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 Zimislecel. 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
Zimislecel
Common Names & Synonyms
Allogeneic, human stem cell-derived, fully differentiated pancreatic islets (SC-islets)
ZIMISLECEL [USAN]
allogenic pancreatic islets derived from a human embryonic stem cell (ESC) line. The initial ESCs are positive for OCT4A (>70%) and stage-specific embryonic antigen-4 (SSEA4; >90%). The pancreatic islets are differentiated from the ESCs in five stages: (1) definitive endoderm induction, (2) gut tube formation, (3) early pancreatic progenitor induction, (4) late pancreatic progenitor induction, and (5) pancreatic endocrine induction. In stage 1 the pluripotent stem cell aggregates are cultured in MCDB-131 serum-free medium supplemented with activin A and 6-[(2-{[4-(2,4-dichlorophenyl)-5-(4-methyl-1H-imidazol-2-yl)pyrimidin-2-yl]amino}ethyl)amino]pyridine-3-carbonitrile (laduviglusib); in stage 2, the cell culture medium is exchanged with medium supplemented with keratinocyte growth factor (KGF); in stage 3 the medium is supplemented with KGF, (1Ξ)-N-(4-benzylpiperazin-1-yl)-1-(3,5-dimethyl-1-phenyl-1H-pyrazol-4-yl)methanimine (SANT-1), (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid (tretinoin), phorbol 12,13-dibutyrate (PDBu), N-benzyl-2-[(pyrimidin-4-yl)amino]-1,3-thiazole-4-carboxamide (thiazovivin), 4-(6-{4-[(propan-2-yl)oxy]phenyl}pyrazolo[1,5-a]pyrimidin-3-yl)quinoline (DMH-1), and activin A; in stage 4 the medium is supplemented with KGF, SANT-1, tretinoin, PDBu, thiazovivin, and activin A; and in stage 5 the medium is supplemented with N-(cyclopropylmethyl)-2-[4-(4-methoxybenzoyl)piperidin-1-yl]-N-[(4-oxo-3,5,7,8-tetrahydro-4H-pyrano[4,3-d]pyrimidin-2-yl)methyl]acetamide (NVP-TNKS656), PDBu, SANT-1, betacellulin, (2S)-2-[2-(3,5-difluorophenyl)acetamido]-N-[(3S)-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl]propanamide (γ-secretase inhibitor XXI), low-dose naltrexone (LDN), activin receptor-like kinase 5 (ALK5) inhibitor, glucocorticoid (GC), thiazovivin, staurosporine, 3-deazaneplanocin A (DZNep), tretinoin, and zinc sulfate. At the end of stage 5 the islet-like aggregates are dissociated into a single cell suspension and cryopreserved. Thawed cells are subsequently reaggregated into islet cell clusters, removing single cells, and then washed before administration. The final substance consists of pancreatic islet β-cells (positive for NK6 homeobox 1 (NKX6.1+) and ISL LIM homeobox 1 (ISL1+)) that synthesize insulin, as well as non-β islet cells (α and δ cell type) and enterochromaffin (EC) cells. There are no detectable residual pluripotent stem cells (OCT 4+/LIN28+)
zimislecel [INN]
Technical Codes
VX-880
