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Deulumateperone - Intra-Cellular Therapies

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Drug Profile

Deulumateperone - Intra-Cellular Therapies

Alternative Names: ITI 1284; ITI-1284 ODT-SL; Lumateperone deuterated - Intra-Cellular Therapies

Latest Information Update: 28 Sep 2026

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Intra-Cellular Therapies
  • Class Antidementias; Antidepressants; Antipsychotics; Organic deuterium compounds; Small molecules
  • Mechanism of Action Dopamine D2 receptor modulators; Glutamate modulators; Serotonin 5-HT2A receptor antagonists; Serotonin uptake inhibitors
  • 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
  • Phase II Agitation; Psychotic disorders
  • Phase I Unspecified
  • No development reported Behavioural disorders; Dementia; Depressive disorders

Most Recent Events

  • 28 Sep 2026 Chemical structure information added
  • 03 Sep 2026 Phase-III clinical trials in Generalised anxiety disorder (Adjunctive treatment) in USA (Sublingual) (CTIS2026-527316-16-00) (NCT07807865)
  • 18 Aug 2026 Intra-Cellular Therapies completes a phase-I trial (In volunteers) in USA (Sublingual, Tablet) (NCT06299410)

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