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Ulotaront (also known as SEP-363856, SEP-383856, or SEP-856) is an investigational, orally active, first-in-class psychotropic small molecule under development for the treatment of schizophrenia, generalized anxiety disorder (GAD), and major depressive disorder (MDD). Unlike traditional antipsychotics that primarily act as dopamine D2 receptor antagonists, ulotaront functions as a dual agonist at the trace amine-associated receptor 1 (TAAR1) and the serotonin 5-HT1A receptor, with no direct binding to dopamine D2 or serotonin 5-HT2A receptors. It was discovered by Sunovion Pharmaceuticals (now Sumitomo Pharma America) in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform. In March 2024, Sumitomo Pharma transferred exclusive global development and commercialization rights for ulotaront to Otsuka Pharmaceutical.
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