Press Releases March 25, 2026

Minerva Neurosciences Presents Data from its Open-label Safety Trial Evaluating Roluperidone Co-administered with Olanzapine at SIRS 2026

Minerva Neurosciences reports no safety concerns in trial combining roluperidone with olanzapine and initiates confirmatory Phase 3 enrollment

By Marcus Reed NERV
Minerva Neurosciences Presents Data from its Open-label Safety Trial Evaluating Roluperidone Co-administered with Olanzapine at SIRS 2026
NERV

Minerva Neurosciences announced data from its open-label safety trial evaluating the co-administration of roluperidone and olanzapine. The study showed no significant safety, pharmacokinetic, or pharmacodynamic issues, supporting continued development. The company is now enrolling a confirmatory Phase 3 trial with topline data expected in the second half of 2027.

Key Points

  • Open-label trial demonstrated safety of roluperidone combined with olanzapine in patients with schizophrenia negative symptoms.
  • No clinically meaningful pharmacokinetic or pharmacodynamic interactions were observed.
  • Confirmatory Phase 3 trial is currently enrolling with topline results anticipated in late 2027.
  • Impacted sectors include biotechnology, pharmaceuticals, and mental health therapeutics markets.

Trial demonstrated no safety concerns when co-administering roluperidone and olanzapine

The Company continues to advance the program, with the confirmatory Phase 3 trial now enrolling and topline data anticipated in the second half of 2027

BURLINGTON, Mass., March 25, 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 the presentation of clinical data from its open‑label safety trial evaluating roluperidone co‑administered with olanzapine at the 2026 Schizophrenia International Research Society (SIRS) Annual Congress, held March 25–29, 2026, at Firenze Fiera in Florence, Italy.

The presentation titled “A Study of Roluperidone Coadministered with Olanzapine in Patients with Negative Symptoms of Schizophrenia” is being delivered by Michael Davidson, MD, Chief Medical Officer of Minerva Neurosciences and highlights safety, pharmacokinetic (PK), and pharmacodynamic (PD) findings from the trial. The trial was designed to assess potential interactions between roluperidone and a widely used antipsychotic, olanzapine. The trial shows no clinically significant adverse effects, no meaningful pharmacokinetic (PK) changes, and no pharmacodynamic (PD) changes during combined administration.

Presentation Details

  • Title: Olanzapine Added to Roluperidone, in Patients With Schizophrenia and Moderate to Severe Negative Symptoms: A Safety Open-Label Trial
  • Presenter / Co-Author: Michael Davidson, MD
  • Session: Pharmaceutical Pipeline
  • Session Chair: Dr. Mark Weiser
  • Date: Thursday, March 26, 2026
  • Session Time: 10:30 AM – 12:00 PM
  • Location: Room Verde
  • Presentation Time: 11:42 AM – 12:00 PM (CET)

The presentation will be made available following the conference on Minerva’s website under the Presentations section at: https://tinyurl.com/MinervaPresentations.

About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia. For more information, please visit the Company’s website.

Contacts:

Investor inquiries:

Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
[email protected]

Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
[email protected]


Risks

  • Clinical trial outcomes remain subject to confirmatory Phase 3 results, which could differ from earlier findings.
  • Potential regulatory challenges in approval and market acceptance of new schizophrenia treatments.
  • Competition in CNS disorder therapeutics may affect commercial success and market share.

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