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Lumateperone - Intra-Cellular Therapies

Drug Profile

Lumateperone - Intra-Cellular Therapies

Alternative Names: CAPLYTA; ITI-007; ITI-722; Lumateperone tosylate

Latest Information Update: 12 Mar 2021

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Intra-Cellular Therapies
  • Class Antidepressants; Antipsychotics; Fluorobenzenes; Piperidines; Pyrroles; Quinoxalines; Sleep disorder therapies; Small molecules; Tosyl compounds
  • Mechanism of Action Dopamine D2 receptor modulators; Glutamate modulators; Serotonin 2A receptor antagonists; 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

  • Marketed Schizophrenia
  • Preregistration Bipolar depression
  • Phase III Behavioural disorders; Major depressive disorder
  • Phase II Sleep maintenance insomnia

Most Recent Events

  • 03 Mar 2021 Intra-Cellular Therapies plans a phase I trial for Schizophrenia (In adolescents) in March 2021 (PO, Capsule) (NCT04779177)
  • 25 Feb 2021 Intra-Cellular Therapies plans a two phase III (Studies 501 and 502) trials for Major depressive disorders (Adjunctive therapy) in 2021
  • 22 Feb 2021 Preregistration for Bipolar depression (Adjunctive treatment) in USA (PO)
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