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Lumateperone - Intra-Cellular Therapies

Drug Profile

Lumateperone - Intra-Cellular Therapies

Alternative Names: ITI-007; ITI-722

Latest Information Update: 21 Nov 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Schizophrenia
  • Phase III Behavioural disorders; Bipolar depression
  • Phase II Sleep maintenance insomnia
  • Clinical Phase Unknown Major depressive disorder
  • No development reported Mental disorders; Mood disorders

Most Recent Events

  • 05 Aug 2019 PDUFA action date extended by US FDA to 27/12/2019 for NDA for Schizophrenia
  • 24 Jul 2019 Intra-Cellular Therapies completes a phase III clinical trial in Bipolar depression (Monotherapy) in USA (PO) (NCT02600494)
  • 08 Jul 2019 Efficacy and adverse events data from two phase III (Study 404; Study 401)trials in Bipolar depression released by Intra-Cellular Therapies
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