Drug Profile


Alternative Names: ITI-007; ITI-722

Latest Information Update: 19 Sep 2017

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Intra-Cellular Therapies
  • Class Antidepressants; Antipsychotics; 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

  • Phase III Behavioural disorders; Bipolar depression; Schizophrenia
  • Phase II Sleep maintenance insomnia
  • Preclinical Mental disorders; Mood disorders

Most Recent Events

  • 24 Aug 2017 Intra-Cellular Therapies plans a phase III trial for Bipolar Depression, in October 2017 (NCT03249376)
  • 23 Aug 2017 Intra-Cellular Therapies intends to submit NDA to the US FDA for Schizophrenia by mid-2018
  • 10 May 2017 Intra-Cellular Therapeutics plans to initiate clinical development of long acting injectable formulation of lumateperone for Mental disorders in 2018
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