Ulotaront (INNTooltip International Nonproprietary Name;[1] developmental codesSEP-363856,SEP-856) is an investigationalantipsychotic that is undergoingclinical trials for the treatment ofschizophrenia andParkinson's diseasepsychosis.[2][3] The medication was discovered in collaboration between PsychoGenics Inc. andSunovion Pharmaceuticals[2] (which was subsequently merged into Sumitomo Pharma[4]) using PsychoGenics' behavior and AI-based phenotypic drug discovery platform, SmartCube.[5]
Research has shown that ulotaront results in a greater reduction from baseline in thePANSS total score thanplacebo.[7] Treatment with ulotaront, as compared withplacebo, was also associated with an improvement insleep quality.[7] Ulotaront was awarded aBreakthrough Therapy designation due to its increased efficacy and greatly reduced side effects compared to current treatments.[8]
TAAR1 agonism is known to reduce the firing rate of dopaminergic neurons. The inhibitory effects of TAAR1 agonists on dopaminergic neurotransmission are most pronounced in hyperdopaminergic states.[13]
The precisepharmacokinetic profile of ulotaront has not been reported, though the developer has suggested that the pharmacokinetic data supports once daily dosing.[10]
As of 2018, Sunovion, the maker of another antipsychotic calledlurasidone (Latuda), is conducting clinical trials on ulotaront in partnership with the preclinical research company PsychoGenics.[3][16][17] The USFood and Drug Administration (FDA) has granted ulotaront thebreakthrough therapy designation.[10][18] In addition to schizophrenia, ulotaront is also being studied for the treatment of psychosis associated withParkinson's disease.[18]
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.[20]
^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.
Notes: (1) TAAR1 activity of ligands varies significantly between species. Some agents that are TAAR1 ligands in some species are not in other species. This navbox includes all TAAR1 ligands regardless of species. (2) See the individual pages for references, as well as theList of trace amines,TAAR, andTAAR1 pages. See also:Receptor/signaling modulators
