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SEP 380135

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Drug Profile

SEP 380135

Alternative Names: SEP-380135

Latest Information Update: 11 Mar 2026

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At a glance

  • Originator Sumitomo Dainippon Pharma; Sunovion Pharmaceuticals
  • Developer Otsuka Pharmaceutical; Sumitomo Pharma; Sumitomo Pharma America
  • Class Antidementias; Antipsychotics; Anxiolytics; Neuropsychotherapeutics; Small molecules
  • Mechanism of Action Undefined mechanism
  • 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 I Agitation; Major depressive disorder; Schizophrenia

Most Recent Events

  • 06 Mar 2026 Otsuka Pharmaceutical plans a phase I mass balance and pharmacokinetics trial in healthy subjects in USA in March 2026 (NCT07455084)
  • 06 Mar 2025 SEP 380135 is still in phase I trials in Agitation in USA (Otsuka Pharmaceuticals pipeline, March 2025)
  • 28 Aug 2024 No recent reports of development identified for phase-I development in Agitation in USA (PO)

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