Lumateperone- Intra-Cellular Therapies

Drug Profile

Lumateperone- Intra-Cellular Therapies

Alternative Names: ITI-007; ITI-722

Latest Information Update: 16 Mar 2018

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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.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 13 Mar 2018 Intra-Cellular Therapies conducts positive pre-NDA meeting with US FDA regarding proposed content and timing of rolling NDA submission of lumateperone for treatment of Schizophrenia
  • 01 Mar 2018 Intra-Cellular announces intention to submit NDA to US FDA for Bipolar depression in 2H 2019
  • 01 Mar 2018 Intra-Cellular plans a clinical trial for Depressive disorders in 2018
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