Reviva Reports Positive 2025 Results, Plans Next Phase 3 Trial for Schizophrenia Drug

Pharmaceutical company highlights strong clinical data, regulatory progress, and upcoming milestones for brilaroxazine development.

Mar. 30, 2026 at 10:38am

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A studio photograph featuring a collection of premium medical instruments and pharmaceutical vials arranged in a minimalist, conceptual composition, symbolizing the scientific research and development behind a new drug therapy.Reviva's clinical development of the schizophrenia drug brilaroxazine represents a meticulous, science-driven approach to addressing a significant unmet medical need.Cupertino Today

Reviva Pharmaceuticals Holdings, Inc. reported its full-year 2025 financial results and recent business highlights, including plans to initiate a second registrational Phase 3 trial (RECOVER-2) for its schizophrenia drug candidate brilaroxazine in mid-2026. The company said its existing clinical data package demonstrates brilaroxazine's broad-spectrum efficacy, consistent safety and tolerability, and favorable treatment adherence over one year of use.

Why it matters

Reviva's progress with brilaroxazine represents an important milestone in the development of a potential new treatment option for the millions of people living with schizophrenia. The drug's positive clinical profile and regulatory path forward could help address significant unmet medical needs in this area.

The details

Reviva reported that the FDA has recommended the company conduct a second Phase 3 clinical trial for brilaroxazine to generate additional efficacy data and expand the safety dataset prior to a New Drug Application submission. The company's existing data package includes two completed randomized, placebo-controlled trials that demonstrated brilaroxazine's efficacy across major symptom domains of schizophrenia, as well as a one-year open-label extension study showing a generally well-tolerated safety profile.

  • Reviva plans to initiate the RECOVER-2 Phase 3 trial in mid-2026, with trial-related activities starting in Q2-2026 and patient enrollment in the U.S. beginning in Q3-2026.
  • The company completed public equity offerings in June 2025, September 2025, and March 2026, raising a total of $29 million to fund the RECOVER-2 trial and other R&D activities.

The players

Laxminarayan Bhat, Ph.D.

Founder, President, and CEO of Reviva Pharmaceuticals Holdings, Inc.

Reviva Pharmaceuticals Holdings, Inc.

A late-stage biopharmaceutical company developing therapies for central nervous system, inflammatory, and cardiometabolic diseases.

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What they’re saying

“With clear and actionable guidance from the Food and Drug Administration (FDA), we are advancing toward initiating our second registrational phase 3 trial (RECOVER-2) and preparing the data package for supporting a New Drug Application (NDA) for brilaroxazine for the treatment of schizophrenia.”

— Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva Pharmaceuticals Holdings, Inc.

What’s next

Reviva plans to initiate the RECOVER-2 registrational Phase 3 trial for brilaroxazine in schizophrenia in mid-2026, with trial-related activities starting in Q2-2026 and patient enrollment in the U.S. planned to begin in Q3-2026.

The takeaway

Reviva's progress with brilaroxazine, including positive long-term clinical data and a clear regulatory path forward, represents an important step in developing a potential new treatment option for the millions of people living with the debilitating symptoms of schizophrenia.