Reviva Pharmaceuticals Holdings, Inc. ((RVPH)) announced an update on their ongoing clinical study.
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Reviva Pharmaceuticals Holdings, Inc. is conducting a Phase 3 clinical study titled ‘Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects With Schizophrenia, Followed by a 52-Week Open-label Extension.’ The study aims to evaluate the safety and efficacy of Brilaroxazine, a novel drug for treating schizophrenia, compared to a placebo over both short and long-term periods.
The intervention being tested is Brilaroxazine, a new chemical entity classified as a Dopamine-Serotonin System Stabilizer. It is intended to treat schizophrenia and related conditions. The drug is administered in fixed doses of 15 mg or 50 mg daily for 28 days, followed by flexible dosing over 52 weeks.
This study is designed as a randomized, parallel-group trial with three treatment arms: two active doses of Brilaroxazine and one placebo. It employs triple masking, meaning that the participant, care provider, and investigator are blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study began on November 29, 2021, with an estimated completion date of December 16, 2024. These dates are crucial for tracking the study’s progress and anticipating when results might impact the market.
The ongoing study could significantly influence Reviva Pharmaceuticals’ stock performance and investor sentiment, especially if Brilaroxazine proves effective. Success in this trial could position Reviva favorably against competitors in the antipsychotic market, potentially driving investor interest.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.