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Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects with an Acute Exacerbation of Schizophrenia, Followed by a 52-Week Open-label Extension

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Trial Profile

Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects with an Acute Exacerbation of Schizophrenia, Followed by a 52-Week Open-label Extension

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs Brilaroxazine (Primary)
  • Indications Schizophrenia
  • Focus Registrational; Therapeutic Use
  • Acronyms RECOVER
  • Sponsors Reviva Pharmaceuticals

    • Most Recent Events

    • 15 Apr 2024 According to a Reviva Pharmaceuticals media release, the company expect to have completed all of the outlined NDA submission requirements by the third quarter of 2025.
    • 28 Mar 2024 According to a Reviva Pharmaceuticals media release, data will be presented at the 2024 Schizophrenia International Research Society (SIRS) Annual Meeting, to be held April 3-7, 2024, in Florence, Italy.
    • 26 Mar 2024 According to a Reviva Pharmaceuticals media release, data from this trial will be presented at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2024 Annual Meeting, to be held in Colorado Springs, CO, USA on March 27-29, 2023.
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