Drug intelligence / Profile preview

ulotaront

Development stage
Phase 3
Lead developer
Otsuka Holdings
Modality
Small Molecules
Administration
Oral
01

Overview

Ulotaront is an investigational oral small molecule antipsychotic with a novel mechanism of action. Unlike conventional antipsychotics that primarily antagonize dopamine D2 receptors, ulotaront acts as an agonist at the trace amine-associated receptor 1 (TAAR1) and as a partial agonist at the serotonin 5-HT1A receptor. It does not significantly antagonize dopamine or serotonin 5-HT2A receptors, which may contribute to its differentiated safety profile regarding movement and metabolic side effects. Ulotaront is being developed for the treatment of schizophrenia (Phase 3), generalized anxiety disorder (Phase 2/3), and as adjunctive therapy for major depressive disorder (Phase 2/3). Development has been discontinued for narcolepsy and psychotic disorders. The drug was granted Breakthrough Therapy Designation by the FDA for schizophrenia[1][2][3][4][5][6].

Brand names
Ulotaront
Other names
ulotaront1-((7S)-5,7-dihydro-4H-thieno(2,3-c)pyran-7-yl)-N-methylmethanamine(S)-1-(4,7-Dihydro-5H-thieno[2,2-c]pyran-7-yl)-N-methylmethanamine
02

Targets

TAAR1 (Trace amine-associated receptor 1)OCT2 (Organic cation transporter 2)HTR1D (5-hydroxytryptamine receptor 1D)HTR1A (Serotonin receptor 1A (5-hydroxytryptamine receptor 1A))

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