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Lumateperone - Intra-Cellular Therapies

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Drug Profile

Lumateperone - Intra-Cellular Therapies

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

Latest Information Update: 11 Aug 2026

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Intra-Cellular Therapies
  • Class Antidementias; Antidepressants; Antipsychotics; Behavioural disorder therapies; Fluorobenzenes; Mood stabilisers; Piperidines; Pyrroles; Quinoxalines; Sleep disorder therapies; Small molecules; Tosyl compounds
  • Mechanism of Action Dopamine D2 receptor modulators; Glutamate modulators; Serotonin 5-HT2A 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Bipolar depression; Major depressive disorder; Schizophrenia
  • Phase III Autism spectrum disorder; Behavioural disorders; Bipolar disorders; Pervasive child development disorders
  • Phase II Sleep maintenance insomnia

Most Recent Events

  • 11 Aug 2026 Intra-Cellular Therapies plans III CANDLE trial for Major depressive disorder in October 2026 (PO) (NCT07747389)
  • 20 May 2026 Intra-Cellular Therapies completes a phase III trial in Behavioural disorders in Bulgaria, Romania, Serbia, USA (PO) (NCT06462612)
  • 27 Apr 2026 Registered for Schizophrenia (Prevention of relapse) in USA (PO)

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