SEP-363856
Ulotaront
Investigational antipsychotic drug
Ulotaront (INN ;[1] developmental codes SEP-363856, SEP-856) is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis.[2][3] The medication was discovered in collaboration between PsychoGenics Inc. and Sunovion Pharmaceuticals[2] (which was subsequently merged into Sumitomo Pharma[4]) using PsychoGenics' behavior and AI-based phenotypic drug discovery platform, SmartCube.[5] Ulotaront is in Phase III of clinical development.
Research has shown that ulotaront results in a greater reduction from baseline in the PANSS total score than placebo.[6] Treatment with ulotaront, as compared with placebo, was also associated with an improvement in sleep quality.[6] Ulotaront was awarded a Breakthrough Therapy designation due to its increased efficacy and greatly reduced side effects compared to current treatments.[7]