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SEP-380135 is an orally administered small-molecule investigational agent that acts on the central nervous system and was discovered via PsychoGenics’ in vivo phenotypic SmartCube platform with AI, in collaboration with Sunovion/Sumitomo Pharma. Preclinical data suggest broad in vivo activity relevant to behavioral and psychological symptoms of dementia, including agitation/aggression, psychomotor hyperactivity, depression, and social interaction deficits, indicating potential utility in agitation and related neuropsychiatric symptoms; its precise molecular target and mechanism have not been disclosed. It is in Phase 1 clinical development in the United States, with Sumitomo Pharma/Otsuka listing it in pipeline materials for agitation and neuropsychiatric indications.[3][4][2][7][5]
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