Developer · NERV · United States
Minerva Neurosciences, Inc.
Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, with roluperidone for negative symptoms of schizophrenia as its lead program.
Pipeline (1)
- SchizophreniaPhase 3Active
Deals & partnerships
- Aug 30, 2007Licensing dealMinerva (via predecessor Cyrenaic Pharmaceuticals) in-licenses roluperidone from Mitsubishi Tanabe PharmaCyrenaic Pharmaceuticals — a predecessor that merged in November 2013 to form Minerva Neurosciences — entered into an exclusive license agreement dated August 30, 2007 with Mitsubishi Tanabe Pharma Corporation (MTPC) for the lead compound CYR-101 (subsequently renamed MIN-101 / roluperidone) and related compounds, granting worldwide development and commercialization rights excluding certain Asian countries (including China, Japan, India and South Korea).
Catalysts · 1 upcoming · 2 reported
- 2H 2027Anticipated
Roluperidone (MIN-101)forSchizophreniaTopline data
Confirmatory Phase 3 (MIN-101C19) 12-week topline (primary: Marder NSFS) expected 2H 2027.
Recently reported
- 2024-02-27missed
Roluperidone (MIN-101)forSchizophreniaRegulatory
FDA issued a Complete Response Letter for the roluperidone NDA; at least one additional positive adequate/well-controlled study required.
- 2020-05-29missed
Roluperidone (MIN-101)forSchizophreniaTopline data
Phase 3 (MIN-101C07) narrowly missed primary PANSS Marder NSFS endpoint in ITT (p<=0.064); nominally significant in mITT (p<=0.044).
Recent activity
- Mar 31, 2026Phase changeRoluperidone (MIN-101)·SchizophreniaPhase 3First patient screened in the global confirmatory Phase 3 (MIN-101C19 / NCT07565428, ~380 patients); 12-week placebo-controlled Phase A (primary: Marder NSFS) plus a longer active-controlled relapse phase vs common antipsychotics. Topline expected 2H 2027.source ↗
- Feb 27, 2024ReadoutRoluperidone (MIN-101)·SchizophreniamissedFDA issued a Complete Response Letter for the roluperidone NDA; at least one additional positive adequate/well-controlled study required.source ↗
- May 29, 2020ReadoutRoluperidone (MIN-101)·SchizophreniamissedPhase 3 (MIN-101C07) narrowly missed primary PANSS Marder NSFS endpoint in ITT (p<=0.064); nominally significant in mITT (p<=0.044).source ↗
- Dec 15, 2017Phase changeRoluperidone (MIN-101)·SchizophreniaPhase 3Confirmatory Phase 3 (MIN-101C07 / NCT03397134) initiated; 12-week double-blind placebo-controlled monotherapy in negative symptoms plus a 40-week open-label extension.source ↗
- Jul 28, 2017Phase changeRoluperidone (MIN-101)·SchizophreniaPhase 2Phase 2b monotherapy study (MIN-101C03; Davidson et al., Am J Psychiatry 2017; n=244) met its primary endpoint: both 32 mg (p<=0.024, d=0.45) and 64 mg (p<=0.004, d=0.57) significantly improved PANSS negative symptoms vs placebo at Week 12.source ↗
Trials recruiting · 1 recruiting of 7 sponsored
- Phase 3Roluperidone (MIN-101)
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
Competitive landscape
Other companies developing against Minerva Neurosciences, Inc.'s targets or indications.
- Intra-Cellular Therapies, Inc.2 compounds5-HT2ASchizophrenia
- Vanda Pharmaceuticals Inc.2 compounds5-HT2ASchizophrenia
- ACADIA Pharmaceuticals Inc.1 compound5-HT2A
- Alkermes plc1 compoundSchizophrenia
- Alto Neuroscience, Inc.1 compoundSchizophrenia
- Atai Beckley N.V. (AtaiBeckley)1 compound5-HT2A
- Beckley Psytech Limited1 compound5-HT2A
- BioXcel Therapeutics, Inc.1 compoundSchizophrenia
- Boehringer Ingelheim International GmbH1 compoundSchizophrenia
- Cerevel Therapeutics Holdings, Inc.1 compoundSchizophrenia
- COMPASS Pathways plc1 compound5-HT2A
- Definium Therapeutics, Inc.1 compound5-HT2A
