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Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma/Sumitomo Pharma America

Drug Profile

Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma/Sumitomo Pharma America

Alternative Names: SEP-363856; SEP-856

Latest Information Update: 28 Dec 2023

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • 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)
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