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Lumateperone - Intra-Cellular Therapies

Drug Profile

Lumateperone - Intra-Cellular Therapies

Alternative Names: ITI-007; ITI-722

Latest Information Update: 28 Jan 2019

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Intra-Cellular Therapies
  • Class Antidepressants; Antipsychotics; Pyrroles; Quinoxalines; Sleep disorder therapies
  • Mechanism of Action Dopamine receptor modulators; NR2B N-Methyl D-Aspartate receptor modulators; Serotonin 2A receptor antagonists; Serotonin plasma membrane transport protein inhibitors; Serotonin uptake inhibitors
  • 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

  • Preregistration Schizophrenia
  • Phase III Behavioural disorders; Bipolar depression
  • Phase II Sleep maintenance insomnia
  • No development reported Mental disorders; Mood disorders

Most Recent Events

  • 28 Jan 2019 No recent reports of development identified for preclinical development in Mental-disorders in USA (Parenteral, Injection)
  • 25 Jan 2019 Intra-Cellular Therapies plans a phase II trial for Schizophrenia in USA in March 2019 (NCT03817528)
  • 18 Dec 2018 The independent data monitoring committee (DMC) recommends to discontinue a phase III trial in Behavioural disorders (Agitation associated with dementia) in USA due to high likelihood of a futile primary endpoint outcome
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