Reviva Pharmaceuticals Advances Novel Drug for Schizophrenia

Reviva Pharmaceuticals Inc. has made significant strides in developing a new treatment for schizophrenia, a complex brain disorder that affects approximately 24 million people worldwide, including 3.7 million in the United States. The company’s novel multimodal neuromodulator, brilaroxazine, aims to address not only the positive symptoms of schizophrenia—such as hallucinations and delusions—but also the negative symptoms that severely impact patients’ quality of life. These negative symptoms include lack of motivation, reduced emotional expression, and lower social drive, which existing medications have often failed to adequately treat.

Traditional antipsychotic treatments for schizophrenia have shown limited effectiveness against these negative symptoms and can lead to side effects such as motor dysfunction, sexual dysfunction, weight gain, and metabolic issues. This has contributed to a significant rate of nonadherence among patients, complicating efforts to manage the illness effectively. Importantly, approximately 30% of schizophrenia patients are classified as treatment-refractory, meaning they do not respond to available therapies.

Innovative Mechanism of Action

Reviva Pharmaceuticals is positioning brilaroxazine as a transformative option in the schizophrenia treatment landscape. The drug targets both serotonin-dopamine signaling pathways and neuroinflammation, which is increasingly recognized as a contributing factor to treatment-resistant schizophrenia. By acting as both a partial agonist and antagonist of serotonin and dopamine receptors, brilaroxazine aims to stabilize the neurotransmitter systems that are disrupted in schizophrenia and related neuropsychiatric disorders.

The clinical profile of brilaroxazine has shown promising results through two large randomized double-blind clinical trials, including a phase 2 and a phase 3 trial. The trials demonstrated strong and sustained efficacy from acute to maintenance treatment over a year, with a large number of patients reporting reductions in their scores on the Positive and Negative Syndrome Scale (PANSS). This scale assesses major symptoms associated with schizophrenia, and the results suggest a well-tolerated safety profile with no serious adverse events reported.

Regulatory Path and Future Prospects

The long-term Open Label Extension (OLE) portion of the RECOVER phase 3 trial was a key milestone for Reviva, as it is critical for the company to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). This formal request for marketing approval requires substantial evidence of the drug’s safety and efficacy, with long-term data from a minimum of 100 patients who have completed twelve months of treatment. In the OLE trial, 159 patients completed twelve months, while 301 completed six months, providing a solid foundation for the application.

Reviva anticipates a pre-NDA meeting with the FDA in the fourth quarter of 2025, which will be pivotal in discussing the approval pathway for brilaroxazine, with potential NDA submission expected by the second quarter of 2026. The outcomes of these regulatory milestones could serve as significant catalysts for the company’s growth and investor interest.

Brilaroxazine is not only being developed for schizophrenia but also shows potential for treating negative symptoms associated with other conditions such as bipolar disorder, major depressive disorder, and attention deficit hyperactivity disorder. Reviva Pharmaceuticals estimates that the market for psychiatric diseases could exceed $50 billion by 2030.

With its innovative approach and positive clinical trial outcomes, Reviva Pharmaceuticals is emerging as a company to watch in the evolving landscape of mental health treatment.