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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Aug 2019

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies
  • Most Recent Events

    • 05 Aug 2019 According to an Intra-Cellular Therapies media release, the company announced that FDA has informed the Company that the planned submission of this additional information constitutes a major amendment to the NDA, resulting in a three-month extension of the Prescription Drug User Fee Act (PDUFA) goal date to December 27, 2019 in order to provide time for a full review of the submission.
    • 05 Aug 2019 According to an Intra-Cellular Therapies media release, the company announced that it recently met with the U.S. Food and Drug Administration (FDA) and reached agreement to submit additional non-clinical information in connection with the FDA ongoing review of the Company New Drug application (NDA) for lumateperone for the treatment of schizophrenia.
    • 23 Jul 2019 According to an Intra-Cellular Therapies media release, the U.S. Food and Drug Administration (FDA) has cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for July 31, 2019 to allow sufficient time to review the additional information requested from the company relating to non-clinical studies. This information may result in an extension of the September 27, 2019 Prescription Drug User Fee Act (PDUFA) target action date.
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