SASINEPROCEL
UNII H366LC5CFP

Substance Identification & Data

This profile provides standardized clinical and technical data for Sasineprocel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) H366LC5CFP.

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

H366LC5CFP

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

SASINEPROCEL

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

INN ID

13417

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

OP-131

Identifier assigned by the United States Adopted Names Council.

Substance Type

Sasineprocel

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 Sasineprocel. 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

Sasineprocel

Common Names & Synonyms

ANPD001 are autologous dopamine neurons precursors derived from induced pluripotent stem cells (iPSCs)

Autologous dopaminergic neuron precursor cells (DANPCs) are derived from human induced pluripotent stem cells (iPSCs). The iPSCs are derived from patient skin fibroblasts that are expanded and reprogrammed by a non-integrating method with plasmid vectors expressing octamer-binding transcription factor 3/4 (OCT-3/4), SRYbox transcription factor 2 (SOX2), Krueppel-like factor 4 (KLF4), and L-Myc. The cells are expanded on recombinant laminin and frozen as intermediates to be then thawed, expanded, dissociated with a proteolytic and collagenolytic enzyme mixture and initially seeded in medium supplemented with Rho-associated protein kinase (ROCK). Differentiation into dopaminergic precursor cells is then performed in neurobasal medium supplemented with serum replacement containing a transforming growth factor-β (TGFβ)/activin-Nodal signaling inhibitor, a bone morphogenetic protein (BMP) inhibitor, a glycogen synthase kinase (GSK) 3 inhibitor, a Sonic hedgehog (Shh) signaling activator and a γ-secretase inhibitor, as well as recombinant brain-derived neurotrophic factor (BDNF), glial cell-line-derived neurotrophic factor (GDNF), transforming growth factor β3 (TGFβ3) and Sonic hedgehog (Shh). The DANPCs are then harvested, washed, and cryopreserved. The final cell population expresses forkhead box protein A2 (FoxA2; >80%) characteristic of dopaminergic neurons, with a minor (<5%) cell population expressing paired box protein (PAX6). Uncommitted iPSCs are absent or present at low level (<0.1%; octamer-binding transcription factor 3/4 (OCT3/4) and vertnin (VRTN)) cell therapy (Parkinson's disease) Description in Proposed INN: List 132 WHO Drug Information, Vol. 38 , No. 4, 2024

SASINEPROCEL [USAN]

Technical Codes

ANPD-001

ANPD001

External Clinical & Regulatory Resources

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