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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: 02 Sep 2026

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

Most Recent Events

  • 20 Aug 2026 Otsuka Pharmaceutical plans a phase III trial for Generalised anxiety disorder(PO, Tablet) in October 2026 (NCT07786454 )(CTIS2026-526032-40-00)
  • 07 Aug 2026 Otsuka initiates a phase-III clinical trial in Generalised anxiety disorder in USA (PO) (NCT07759128)
  • 28 Jul 2026 Phase-III clinical trials in Generalised anxiety disorder in USA (PO) (NCT07759128)

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