Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma
Alternative Names: SEP-363856; SEP-856Latest Information Update: 27 Aug 2024
At a glance
- Originator Sumitomo Pharma
- Developer Otsuka Pharmaceutical; Sumitomo Pharma; Sumitomo Pharma America
- Class Amines; Antidepressants; Antipsychotics; Anxiolytics; Neuropsychotherapeutics; Pyrans; Sleep disorder therapies; Small molecules; Thiophenes
- Mechanism of Action 5-HT1A serotonin receptor agonists; Trace amine-associated receptor 1 agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Schizophrenia
- Phase II/III Generalised anxiety disorder; Major depressive disorder
- Discontinued Narcolepsy; Psychotic disorders
Most Recent Events
- 27 Aug 2024 Discontinued - Phase-I for Narcolepsy (In the elderly, In adults) in USA (PO)
- 27 Aug 2024 Discontinued - Phase-II for Psychotic disorders (In the elderly, In adults) in USA (PO)
- 12 Apr 2024 Sumitomo Pharma terminates a phase III trial in Schizophrenia in Japan (PO) due to company business strategy (NCT05359081)