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 diseasepsychosis.[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]
The precise pharmacokinetic profile of ulotaront has not been reported, though the developer has suggested that the pharmacokinetic data supports once daily dosing.[9]
As of 2018, Sunovion, the maker of another antipsychotic called lurasidone (Latuda), is conducting clinical trials on ulotaront in partnership with the preclinical research company PsychoGenics.[3][12][13] The U.S. Food and Drug Administration has granted ulotaront the breakthrough therapy designation.[9][14] In addition to schizophrenia, ulotaront is also being studied for the treatment of psychosis associated with Parkinson's disease.[14]
In July 2023, the pharmaceutical company behind the drug announced that the drug had failed to outperform placebo in the treatment of acutely psychotic patients with schizophrenia, as measured by the PANSS.[16]
^Tatsumi K, Kirkpatrick B, Strauss GP, Opler M (April 2020). "The brief negative symptom scale in translation: A review of psychometric properties and beyond". European Neuropsychopharmacology. 33: 36–44. doi:10.1016/j.euroneuro.2020.01.018. PMID32081498. S2CID211141678.
† References for all endogenous human TAAR1 ligands are provided at List of trace amines
‡ References for synthetic TAAR1 agonists can be found at TAAR1 or in the associated compound articles. For TAAR2 and TAAR5 agonists and inverse agonists, see TAAR for references.