Drugs / Roluperidone
Roluperidone
also known as
MIN-101 · CYR-101 · CYR-101 HYDROCHLORIDE DIHYDRATE · MIN-101 FREE BASE · MR-32 · MT-210 · Roluperidona · ROLUPERIDONE HYDROCHLORIDE
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | negative symptoms of schizophrenia | 2024-02-27 | “Complete Response Letter (CRL) to the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.” minervaneurosciences.com ↗ |
| Filed | US (FDA) | — | negative symptoms of schizophrenia | 2023-04-27 | “On April 27, 2023, the FDA confirmed the filing of Minerva’s NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.” minervaneurosciences.com ↗ “FDA filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023.” minervaneurosciences.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06107803 | Oct 2023 → Jan 2024 | schizophrenia | Minerva Neurosciences | Completed | No outcome recorded |
| Phase 1 | NCT03072056 | Jan → Jul 2017 | — | Minerva Neurosciences | Completed | No outcome recorded |
| Phase 1 | NCT03038646 | Nov 2016 → Apr 2017 | — | Minerva Neurosciences | Completed | No outcome recorded |
| Phase 1 | NCT02232529 | Sep 2014 → Feb 2015 | schizophrenia | Minerva Neurosciences | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00861796 | Mar 2008 → May 2010 | schizophrenia | Cyrenaic Pharmaceuticals | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT07565428 | Apr 2026 → Dec 2027 expected | — | Minerva Neurosciences | Recruiting | No outcome recorded |
| Phase 3 | NCT03397134 | Dec 2017 → May 2020 | — | Minerva Neurosciences | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-03-25 | Minerva Neurosciences | Results Minerva Neurosciences Presents Data from its Open-label Safety Trial Evaluating Roluperidone Co-administered with Olanzapine at SIRS 2026 minervaneurosciences.com ↗
The trial shows no clinically significant adverse effects, no meaningful pharmacokinetic (PK) changes, and no pharmacodynamic (PD) changes during combined administration. |
| 2025-08-14 | Minerva Neurosciences | Regulatory Minerva Neurosciences Provides Business Updates and Second Quarter Financial Results minervaneurosciences.com ↗
The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. |
| 2024-02-27 | Minerva Neurosciences | Regulatory Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia minervaneurosciences.com ↗ |
| 2023-05-10 | Minerva Neurosciences | Regulatory Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗
FDA confirms acceptance of the filing of the NDA for roluperidone |
| 2023-05-01 | Minerva Neurosciences | Regulatory Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗ |
| 2022-12-28 | Minerva Neurosciences | Regulatory Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗
the refuse to file letter dated October 14, 2022 remains in effect |
| 2022-10-17 | Minerva Neurosciences | Regulatory Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗
today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. |
| 2022-08-22 | Minerva Neurosciences | Regulatory Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia minervaneurosciences.com ↗ |
| 2022-02-28 | Minerva Neurosciences | Results Minerva Neurosciences Announces Publication of Roluperidone Phase 3 Study Results in Schizophrenia Bulletin minervaneurosciences.com ↗
The study authors conclude that this study confirms the potential of roluperidone to treat the negative symptoms in individuals with schizophrenia as well as improve everyday functioning. |
| 2021-11-03 | Minerva Neurosciences | Regulatory Minerva Neurosciences Announces FDA Recommendation for Type C Meeting to Discuss Evidence for Use of Roluperidone as Monotherapy for the Treatment of Negative Symptoms in Patients with Schizophrenia in Advance of Potential NDA Submission minervaneurosciences.com ↗ |
| 2021-09-30 | Minerva Neurosciences | Results Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, and Planned Commercial Formulations of Roluperidone for Treatment of Negative Symptoms of Schizophrenia minervaneurosciences.com ↗
The study met all key pharmacokinetic (PK) objectives and the data demonstrate bioequivalence across the various formulations. |
| 2021-05-11 | Minerva Neurosciences | Results Minerva Neurosciences Announces the Results of the Phase 3 Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia Following the Completion of the 40-Week Open-Label Extension minervaneurosciences.com ↗ |
| 2020-05-29 | Minerva Neurosciences | Results Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗
Roluperidone was generally well tolerated with a safety profile comparable to placebo |
| 2019-04-11 | Minerva Neurosciences | Results Minerva Neurosciences Presents Pre-Clinical Data Suggesting a Mechanistic Role of Roluperidone in Addressing Negative Symptoms of Schizophrenia minervaneurosciences.com ↗
Findings show roluperidone increases release and gene expression of BDNF, as well as release of GDNF |
| 2018-11-19 | Minerva Neurosciences | Results Minerva Neurosciences Announces Results of Dose Escalation Study Evaluating Roluperidone (MIN-101) Administered at Supra-Therapeutic Doses in Healthy Volunteers minervaneurosciences.com ↗
All doses tested up to 256 milligrams appear safe and well tolerated with no significant changes in cardiac repolarization and QTc intervals |
| 2018-08-22 | Minerva Neurosciences | Results Minerva Neurosciences Announces Findings Showing Effect of Roluperidone on Brain-Derived Neurotrophic Factor (BDNF) minervaneurosciences.com ↗
The level of BDNF release following the administration of roluperidone increased by approximately 20 percent, comparable to the effect shown by pridopidine, the reference molecule used in the study. |
| 2018-05-17 | Minerva Neurosciences | Results Journal of Clinical Psychiatry Publishes Positive Results of Cognitive Performance From Phase 2B Trial of Roluperidone, Under Development by Minerva Neurosciences for the Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders (CNS), today announced that The Journal of Clinical Psychiatry has published online results demonstrating cognitive improvements in patients with schizophrenia treated with roluperidone (MIN-101). |
| 2017-07-31 | Minerva Neurosciences | Results American Journal of Psychiatry Publishes Minerva Neurosciences’ MIN-101 Phase 2b Trial Results for Treatment of Negative Symptoms in Schizophrenia minervaneurosciences.com ↗
today announced that the American Journal of Psychiatry has published online results from its previously reported Phase 2b clinical trial of MIN-101. |
| 2017-01-20 | Minerva Neurosciences | Results Additional Data Analyses From Phase IIb Trial of MIN-101 in Schizophrenia Underscore Benefit in Multiple Measurements of Cognitive Function minervaneurosciences.com ↗
We have recently completed additional analyses from our Phase IIb trial with MIN-101 that show significant improvements in several sub-tests of cognitive functioning, including motor tests and verbal fluency in patients with schizophrenia. |
| 2016-12-05 | Minerva Neurosciences | Results Minerva Neurosciences’ Clinical Data Featured at The American College of Neuropsychopharmacology Annual Meeting minervaneurosciences.com ↗
Oral presentation highlights specific improvements in negative symptoms and cognition observed in schizophrenic patients treated with MIN-101 in Phase IIB trial |
| 2016-10-26 | Minerva Neurosciences | Results Minerva Neurosciences Announces Positive Data From Six-Month Extension of Phase IIb Trial of MIN-101 Monotherapy in Schizophrenia minervaneurosciences.com ↗
Minerva Neurosciences Announces Positive Data From Six-Month Extension of Phase IIb Trial of MIN-101 Monotherapy in Schizophrenia |
| 2016-05-26 | Minerva Neurosciences | Results Minerva Neurosciences Announces Positive Results From Phase IIB Trial of MIN-101 Monotherapy in Schizophrenia minervaneurosciences.com ↗
The study successfully achieved its primary endpoint, demonstrating the statistically significant benefit of MIN-101 over placebo in improving negative symptoms as measured by the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS). |
| 2015-12-29 | Minerva Neurosciences | Regulatory Minerva Neurosciences Announces Update on MIN-101 Clinical Development Program minervaneurosciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for MIN-101, a first-in-class 5-HT2a and sigma2 antagonist in clinical development for the treatment of schizophrenia. |
| 2014-04-03 | Minoryx Therapeutics, S.L. | Regulatory Minoryx receives Orphan Drug Designation for MIN-101 minoryx.com ↗
Minoryx Therapeutics announced that the European Commission has granted orphan drug designation to MIN-101 for the treatment of X-linked Adrenoleukodystrophy (ALD). |
All press releases naming this drug 43 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Roluperidone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03397134 ↗ |
| Known as | CYR-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00861796 ↗ |
| Known as | CYR-101 HYDROCHLORIDE DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297605 ↗ |
| Known as | MIN-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03038646 ↗ |
| Known as | MIN-101 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297605 ↗ |
| Known as | MR-32 | “32 mg MIN-101 of the current modified-release formulation (comparator) identified as MR-32 formulation administered in the fasted state” NCT03038646 ↗ |
| Known as | MT-210 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297605 ↗ |
| Known as | Roluperidona | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297605 ↗ |
| Known as | ROLUPERIDONE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297605 ↗ |
| Action | Inhibit | “a compound with antagonist properties for 5-HT2A, sigma2, and α1A-adrenergic receptors” PMID 35211743 ↗ May 2022 |
| Modality | Small molecule | — CHEMBL4297605 ↗ |
| Route | Oral | “when administered orally” NCT00861796 ↗ |