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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: 25 Apr 2024

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At a glance

  • Originator Dainippon Sumitomo Pharma
  • Developer 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
  • 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

  • 12 Apr 2024 Sumitomo Pharma terminates a phase III trial in Schizophrenia in Japan (PO) due to company business strategy (NCT05359081)
  • 01 Apr 2024 Sumitomo Pharma completes a phase-III clinical trials in Schizophrenia (In the elderly, In adults, Treatment-experienced) in USA (PO) (NCT05628103)
  • 15 Mar 2024 Sumitomo Pharma completes a phase I trial in Schizophrenia (In adults, Treatment-experienced) in USA (PO) (NCT05848700)
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