Ulotaront ulotaront PHASE3
Drug Profile
ModalitySmall molecule
RouteORAL
Therapy AreaNeurology
Peak Sales Est$2000M
Formulations[]
Companies
4578 (LICENSEE)100%
Mechanism: TAAR1/5-HT1A Agonist
Expert: Trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity. Modulates mesolimbic and mesocortical dopaminergic circuits via indirect regulation of dopamine neuron firing, providing antipsychotic efficacy without D2 receptor blockade.
Everyday: Activates a recently discovered receptor (TAAR1) in the brain that modulates dopamine without directly blocking dopamine receptors — like adjusting the volume on a speaker indirectly through a remote control rather than covering the speaker itself.
Targets: []
Programs (3)
IndicationStageKey StudyRegional Status
SchizophreniaPHASE3DIAMOND 5 (relapse prevention)[]
MDD adjunctivePHASE2NCT05593029[]
GADPHASE2NCT05729373[]
Upcoming Catalysts (1)
Ulotaront - Schizophrenia - Ph3 - Relapse Prevention (DIAMOND 5) H2 2026
Notes
TAAR1/5-HT1A agonist. Novel non-D2 mechanism. Phase 3 DIAMOND 1&2 FAILED primary endpoints in schizophrenia (large placebo effect). DIAMOND 5 relapse prevention ongoing. Otsuka gained exclusive worldwide rights from Sumitomo Pharma Mar 2024.
Data from Supabase · Updated 2026-03-24