Global InformationUlotaront information
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| Other names | SEP-363856; SEP-856 |
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| Formula | C9H13NOS |
| Molar mass | 183.27 g·mol−1 |
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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]
- ^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. 34 (3). 2020.
Proposed INN: List 124 – COVID-19 (special edition)
- ^ a b "SEP 363856". AdisInsight. Springer Nature Switzerland AG. Retrieved 29 December 2018.
- ^ Brooks M. "New Psychotropic Drug for Schizophrenia Promising in Early Testing". Medscape. Reuters Health Information. Retrieved 29 December 2018.
- ^ "US Sumitomo Pharma Subsidiaries Combine to Form Sumitomo Pharma America". American Pharmaceutical Review. 7 April 2023. Retrieved 10 July 2023.
- ^ "Sunovion Presents Data From Marketed and Late-Stage Development Psychiatric Compounds At The American Psychiatric Association (APA) Annual Meeting 2021". www.businesswire.com. 2021-05-03. Retrieved 2021-09-09.
- ^ a b Koblan KS, Kent J, Hopkins SC, Krystal JH, Cheng H, Goldman R, Loebel A (April 2020). "A Non-D2-Receptor-Binding Drug for the Treatment of Schizophrenia". The New England Journal of Medicine. 382 (16): 1497–1506. doi:10.1056/NEJMoa1911772. PMID 32294346.
- ^ "Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia". www.businesswire.com. 2019-05-10. Retrieved 2021-09-09.