Core Insights - Brilaroxazine is a newly discovered chemical entity with strong affinity and selectivity for serotonin and dopamine receptors, relevant for conditions such as schizophrenia, psoriasis, and interstitial lung diseases like pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH) [1][4] Patent and Regulatory Developments - The European Patent Office has granted patent EP3244896 for brilaroxazine, covering its use in treating PH and PAH, including in patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD) [8] - Similar patents have been granted in key markets including the United States, China, and Japan [2] Clinical Data and Efficacy - Brilaroxazine has shown a favorable safety and tolerability profile in over 800 subjects across multiple clinical trials, with significant reductions in proinflammatory biomarkers in a Phase 3 study for schizophrenia [4][13] - The global Phase 3 RECOVER-1 trial demonstrated that brilaroxazine met all primary and secondary endpoints, showing statistically significant reductions in major symptom domains and proinflammatory cytokines at week 4 [4] - Positive data from a drug-drug interaction study indicated no clinically significant interactions with CYP3A4 inhibitors [4] Future Development Plans - The company plans to explore brilaroxazine for additional neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD) [4]
Reviva Announces Grant of European Patent Covering Use of Brilaroxazine for the Treatment of Pulmonary Hypertension