Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma/Sumitomo Pharma America
Alternative Names: SEP-363856; SEP-856Latest Information Update: 28 Dec 2023
At a glance
- Originator Dainippon Sumitomo Pharma
- Developer Sumitomo Pharma; Sumitomo Pharma America
- Class Amines; Antidepressants; Antipsychotics; Anxiolytics; 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 Major depressive disorder; Schizophrenia
- Phase II/III Generalised anxiety disorder
- Phase II Psychotic disorders
- Preclinical Mental disorders
- No development reported Narcolepsy
Most Recent Events
- 19 Dec 2023 Sumitomo Pharma terminates the phase III DIAMOND 3 trial in Schizophrenia (In adolescents, In adults) in USA, Bulgaria, Colombia, Croatia, Latvia, Russia, Serbia and Ukraine, due to main goals achieved (EudraCT2019-000696-16) (NCT04109950)
- 27 Sep 2023 Sunovion Pharmaceuticals completes a phase I trial for Schizophrenia (In adults, In the elderly, Treatment experienced) in USA (PO,Tablet) (NCT05402111)
- 22 Aug 2023 Sunovion completes a phase I trial for Schizophrenia in USA (PO, Tablet) (NCT05463770)