Reviva Pharmaceuticals Plans RECOVER-2 Phase 3 Trial for Schizophrenia Drug Brilaroxazine

Reuters

Dec 23

Reviva Pharmaceuticals Plans RECOVER-2 Phase 3 Trial for Schizophrenia Drug Brilaroxazine

Reviva Pharmaceuticals Holdings Inc. announced plans to initiate the RECOVER-2 Phase 3 registrational trial for brilaroxazine, a novel serotonin-dopamine and neuroinflammatory signaling modulator for the treatment of schizophrenia. The initiation of the trial is expected in the first half of 2026, pending sufficient financing. This decision follows written feedback from the U.S. Food and Drug Administration (FDA) after a pre-New Drug Application (pre-NDA) meeting, in which the FDA recommended a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission. The RECOVER-2 trial will be similar in design to the previously completed RECOVER Phase 3 trial. No new clinical results were presented at this time.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Reviva Pharmaceuticals Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9616417) on December 23, 2025, and is solely responsible for the information contained therein.

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