GlobeNewswire·Mar 31, 2026, 4:05 PM ET

Minerva Neurosciences Announces First Patient Screened in Global Phase 3 Confirmatory Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia

Minerva Neurosciences has screened the first patient in the global Phase 3 MIN-101C19 trial for roluperidone as monotherapy to treat negative symptoms of schizophrenia.
The trial will enroll approximately 380 adults aged 18–55 with moderate to severe negative symptoms across roughly 40 sites in the US & Europe.
This confirmatory study follows FDA discussions & builds on consistent efficacy results from prior pivotal Phase 2b (C03) & Phase 3 (C07) trials using a 64 mg dose.
No FDA-approved treatments currently exist for negative symptoms of schizophrenia, making roluperidone the only late-stage candidate for this population.
The trial utilizes a two-part design: Phase A is a 12-week placebo-controlled study to assess primary efficacy, while Phase B extends for 40 weeks to compare relapse rates against active antipsychotics.
Topline data for the 12-week Phase A primary efficacy endpoint are expected in the second half of 2027.
The primary endpoint evaluates the change from baseline in the Marder Negative Symptoms Factor Score (NSFS), with the Personal and Social Performance (PSP) total score as the sole key secondary endpoint.
Phase B employs a double-dummy, active-controlled design comparing continued roluperidone treatment to risperidone, aripiprazole, or olanzapine to monitor relapse of positive symptoms.