Ulotaront

Ulotaront
Clinical data
Other namesSEP-363856; SEP363856; SEP-856; SEP856
Identifiers
IUPAC name
  • 1-[(7S)-5,7-dihydro-4H-thieno[2,3-c]pyran-7-yl]-N-methylmethanamine
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
ChEBI
Chemical and physical data
FormulaC9H13NOS
Molar mass183.27 g·mol−1
3D model (JSmol)
SMILES
  • CNC[C@H]1C2=C(CCO1)C=CS2
InChI
  • InChI=1S/C9H13NOS/c1-10-6-8-9-7(2-4-11-8)3-5-12-9/h3,5,8,10H,2,4,6H2,1H3/t8-/m0/s1
  • Key:ABDDQTDRAHXHOC-QMMMGPOBSA-N

Ulotaront (INNTooltip International Nonproprietary Name;[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 clinical trial for schizophrenia, phase II/III for generalized anxiety disorder and major depressive disorder, and discontinued for narcolepsy and psychotic disorders.[6]

Research has shown that ulotaront results in a greater reduction from baseline in the PANSS total score than placebo.[7] Treatment with ulotaront, as compared with placebo, was also associated with an improvement in sleep quality.[7] Ulotaront was awarded a Breakthrough Therapy designation due to its increased efficacy and greatly reduced side effects compared to current treatments.[8]

  1. ^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. 34 (3). 2020. Proposed INN: List 124 – COVID-19 (special edition)
  2. ^ a b "SEP 363856". AdisInsight. Springer Nature Switzerland AG. Retrieved 29 December 2018.
  3. ^ Brooks M. "New Psychotropic Drug for Schizophrenia Promising in Early Testing". Medscape. Reuters Health Information. Archived from the original on 21 June 2019. Retrieved 29 December 2018.
  4. ^ "US Sumitomo Pharma Subsidiaries Combine to Form Sumitomo Pharma America". American Pharmaceutical Review. 7 April 2023. Archived from the original on 11 July 2023. Retrieved 10 July 2023.
  5. ^ "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.
  6. ^ "Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma - AdisInsight".
  7. ^ a b Koblan KS, Kent J, Hopkins SC, Krystal JH, Cheng H, Goldman R, et al. (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.
  8. ^ "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.
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