Reviva Pharmaceuticals Holdings, Inc. announced over 30% enrollment in the United States, and initiation and ongoing enrollment across sites in Europe for the pivotal Phase 3 RECOVER study evaluating brilaroxazine for the treatment of schizophrenia. The Company has received regulatory approval for initiating the study in Asia (India), with enrollment at multiple sites in India expected in 2022. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo.

Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Since Reviva initiated its first clinical site at the end of January in the United States, the Company continues to make progress and is on pace with patient enrollment and site initiation in geographically diverse centers across this global clinical study.