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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: 16 May 2024

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At a glance

  • Drugs Brilaroxazine (Primary)
  • Indications Schizophrenia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RECOVER
  • Sponsors Reviva Pharmaceuticals
  • Most Recent Events

    • 15 May 2024 According to a Reviva Pharmaceuticals media release, company is on track to complete the 12 months long-term safety study in Q4 2024
    • 15 May 2024 According to a Reviva Pharmaceuticals media release, company is close to gathering long-term safety data in 100 patients with one year of treatment, which is a requirement for our planned New Drug Application (NDA) submission to the Food and Drug Administration (FDA) expected in Q4 2025.
    • 15 May 2024 According to a Reviva Pharmaceuticals media release, 358 enrolled and 223 patients currently on treatment across sites in the USA, Europe and Asia
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