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Minerva Neurosciences Announces First Patient Screened in Global Phase 3 Confirmatory Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia
Roluperidone has been de-risked by consistent positive results in two prior pivotal trials and remains the only late-stage drug candidate for this high-need
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Roluperidone has been de-risked by consistent positive results in two prior pivotal trials and remains the only late-stage drug candidate for this high-need population Efficacy topline data expected 2H 2027 BURLINGTON, Mass., March 31, 2026 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that the first patient has been screened in its global, confirmatory Phase 3 clinical trial evaluating roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia. Negative symptoms, including avolition (severe lack of motivation), anhedonia (inability to experience pleasure) and social withdrawal can lead to profound personal and functional impairment and represent one of the greatest unmet needs in schizophrenia. There are currently no FDA-approved treatments with this indication. The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including the United States (US) and multiple European countries. This confirmatory Phase 3 trial follows productive discussions with the FDA on the overall design and efficacy assessments. It builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07), both of which demonstrated consistent improvements in negative symptoms with the 64 mg dose of roluperidone. “Initiation of this confirmatory Phase 3 trial is an important milestone for Minerva and for patients living with persistent and impairing negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva Neurosciences. “With no approved treatments for this indication in the US, roluperidone remains the only late-stage candidate in development for this population. The study builds directly on our prior experience showing consistent results across the two earlier trials and our execution strategy gives us confidence in our timelines.” “Patients with schizophrenia often live with persistent negative symptoms such as avolition and anhedonia - challenges that remain even when positive symptoms are controlled with current therapies,” said Dr. Elan Cohen, Principal Investigator at CenExel Marlton, New Jersey and Lead Coordinating Investigator for the trial....