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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: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2025

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At a glance

  • Drugs Brilaroxazine (Primary)
  • Indications Schizophrenia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RECOVER; RECOVER-1
  • Sponsors Reviva Pharmaceuticals

Most Recent Events

  • 13 Nov 2025 According to a Reviva Pharmaceuticals media release, data from the trial were presented at the Central Nervous System (CNS) Summit in Boston, MA, November 2-5, 2025
  • 13 Nov 2025 According to a Reviva Pharmaceuticals media release, company is preparing for a pre-NDA meeting with the Food and Drug Administration (FDA) in the fourth quarter of the year and continue to target a potential NDA submission in the second quarter of 2026.
  • 12 Nov 2025 According to a Reviva Pharmaceuticals media release, data from this study will be presented as a late-breaker poster presentation at the 2025 Neuroscience meeting taking place November 15-19, 2025 in San Diego, CA.

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