Minerva Neurosciences' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Minerva Neurosciences (NERV).
Over the past two years, Minerva Neurosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Roluperidone. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Roluperidone (MIN-101) FDA Regulatory Events
Roluperidone (MIN-101) is a drug developed by Minerva Neurosciences for the following indication: Schizophrenia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Roluperidone (MIN-101)
- Announced Date:
- March 31, 2026
- Indication:
- Schizophrenia
Announcement
Minerva Neurosciences, Inc. 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.
AI Summary
Minerva Neurosciences announced that the first patient has been screened in its global, confirmatory Phase 3 trial testing roluperidone as a single (monotherapy) treatment for negative symptoms of schizophrenia. Negative symptoms—such as avolition (severe lack of motivation), anhedonia (inability to feel pleasure), and social withdrawal—can cause major personal and functional problems and are considered one of the biggest unmet needs in schizophrenia care.
Roluperidone has shown consistent positive results in two prior pivotal trials, which the company says reduces development risk. It remains the only late-stage drug candidate focused specifically on this high-need patient group.
The ongoing Phase 3 study aims to confirm those earlier findings, and Minerva expects to report efficacy topline data in the second half of 2027. If successful, roluperidone could offer a new option for patients whose negative symptoms are not helped by current treatments.
Read Announcement- Drug:
- Roluperidone (MIN-101)
- Announced Date:
- March 25, 2026
- Indication:
- Schizophrenia
Announcement
Minerva Neurosciences, Inc. 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.
AI Summary
Minerva Neurosciences announced that it presented clinical data from an 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 in Florence, Italy. The presentation covered safety findings and trial details for clinicians and researchers attending the meeting.
The trial demonstrated no safety concerns when roluperidone was given alongside olanzapine. Minerva said it is continuing to advance the program and has a confirmatory Phase 3 trial now enrolling. The company expects topline Phase 3 data in the second half of 2027, which would be an important milestone for evaluating the therapy’s effectiveness and broader safety profile.
The presentation will be posted after the conference on Minerva’s website under the Presentations section at: https://tinyurl.com/MinervaPresentations.
Read Announcement
Minerva Neurosciences FDA Events - Frequently Asked Questions
As of now, Minerva Neurosciences (NERV) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Minerva Neurosciences (NERV) has reported FDA regulatory activity for Roluperidone (MIN-101).
The most recent FDA-related event for Minerva Neurosciences occurred on March 31, 2026, involving Roluperidone (MIN-101). The update was categorized as "Provided Update," with the company reporting: "Minerva Neurosciences, Inc. 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."
Currently, Minerva Neurosciences has one therapy (Roluperidone (MIN-101)) targeting the following condition: Schizophrenia.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:NERV last updated on 4/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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