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Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma

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Drug Profile

Ulotaront - Otsuka Pharmaceutical/Sumitomo Pharma

Alternative Names: SEP-363856; SEP-856

Latest Information Update: 04 Apr 2025

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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
  • 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 Schizophrenia
  • Phase II/III Generalised anxiety disorder; Major depressive disorder
  • Discontinued Narcolepsy; Psychotic disorders

Most Recent Events

  • 25 Feb 2025 Otsuka Pharmaceutical initiates a phase III trial for Schizophrenia (Treatment-experienced) in USA (PO) (NCT06894212)
  • 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)

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