New European Patent Strengthens Reviva’s Global IP Portfolio For Brilaroxazine Across CNS And Lung Disorders

Reviva Pharmaceuticals Holdings, Inc., a late-stage biopharma company advancing therapies for CNS, inflammatory, and cardiometabolic diseases, announced that the European Patent Office (EPO) has granted European Patent 3749324 covering the use of brilaroxazine for treating pulmonary fibrosis, including idiopathic pulmonary fibrosis (IPF). This new patent strengthens the drug’s global intellectual property portfolio, which already includes protections in the U.S., China, and Japan. Brilaroxazine also holds Orphan Drug Designation from the U.S. FDA for IPF treatment.

“Securing this latest patent further strengthens our intellectual property portfolio and underscores the broad therapeutic relevance of brilaroxazine’s unique mechanism of action in chronic fibrotic disorders like pulmonary fibrosis or IPF,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “With a late-stage asset that in our trials has been well-tolerated across large patient populations, we are poised to further expand clinical development from schizophrenia into additional high-value indications with the potential for multiple paths to value creation for our brilaroxazine program.”

Brilaroxazine is a novel, in-house discovered compound with high affinity and selectivity for key serotonin and dopamine receptors, both of which are central to the mechanisms underlying several diseases such as schizophrenia, psoriasis, pulmonary hypertension, and IPF. The compound’s multimodal receptor activity positions it as a promising candidate for a range of CNS and inflammatory disorders.

Reviva previously reported positive Phase 3 RECOVER trial results for brilaroxazine in schizophrenia, where it achieved all primary and secondary endpoints, demonstrating clinically meaningful symptom reductions and anti-inflammatory effects at week 4 with the 50 mg dose. The drug showed a safety profile comparable to placebo with lower discontinuation rates. Additionally, a drug-drug interaction study indicated no significant interaction with CYP3A4 inhibitors, supporting its favorable pharmacological profile. Reviva plans to expand brilaroxazine’s development into bipolar disorder, major depressive disorder (MDD), and ADHD, aiming to broaden its therapeutic reach.