COMPANY
Minerva Neurosciences
Timeline
- Trial start Phase 3: Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone a source ↗
- Raise Private placement: $200M (up to, as announced), announced Oct 21, 2025. Source: SEC filing. source ↗
- Trial start Phase 1: A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Sym source ↗
- Trial start Phase 2: A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder source ↗
- Trial start Phase 3: Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia source ↗
- Trial start Phase 1: A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers source ↗
- Trial start Phase 1: A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects source ↗
- Trial start Phase 1: Pharmacokinetic Study of MIN-101 in Healthy Subjects source ↗
Upcoming milestones
- 2027-12 (ESTIMATED) · Phase 3 · Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antips · NCT07565428
Funding
- Private placement: $200M (up to, as announced), announced Oct 21, 2025. Source: SEC filing. source ↗
Clinical trials (lead sponsor) 7
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07565428 | Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications | Phase 3 | Recruiting | Apr 23, 2026 | 2027-12 (estimated) |
| NCT06107803 | A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia | Phase 1 | Completed | Oct 13, 2023 | Jan 12, 2024 (actual) |
| NCT03397134 | Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia | Phase 3 | Completed | Dec 15, 2017 | May 26, 2020 (actual) |
| NCT03446846 | A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder | Phase 2 | Completed | Mar 30, 2018 | Nov 21, 2019 (actual) |
| NCT03038646 | A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects | Phase 1 | Completed | Nov 30, 2016 | Apr 20, 2017 (actual) |
| NCT03072056 | A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers | Phase 1 | Completed | Jan 9, 2017 | Jul 7, 2017 (actual) |
| NCT02232529 | Pharmacokinetic Study of MIN-101 in Healthy Subjects | Phase 1 | Completed | 2014-09 | 2015-02 (actual) |