Lumateperone

Drug Profile

Lumateperone

Alternative Names: ITI-007; ITI-722

Latest Information Update: 29 Nov 2016

Price : $50

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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • 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

  • 09 Nov 2016 Pooled adverse events and efficacy data from three trials (ITI-007-005, ITI-007-301 and ITI-007-302) in Schizophrenia released by Intra-Cellular Therapeutics
  • 28 Sep 2016 Efficacy data from the phase III Study 302 in Schizophrenia released by Intra-Cellular Therapies
  • 30 Jun 2016 Intra-Cellular Therapies completes enrolment in its phase III trial for Schizophrenia in USA (9198844; NCT02469155)
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