roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences 
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 3 Diseases   1 Trial   1 Trial   126 News 
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Journal, Monotherapy:  Roluperidone monotherapy, a treatment for negative symptoms in schizophrenia. (Pubmed Central) -  Jun 24, 2025   
    The patients who were symptomatic stable for 3 or 6 months before antipsychotic drug withdrawal, showed a very low prevalence of psychotic symptoms worsening over 6 or 9 months trials duration. Focus: Treatment of primary negative symptoms in a subgroup of patients suffering from schizophrenia.
  • ||||||||||  Review, Journal:  Third-Generation Antipsychotics: The Quest for the Key to Neurotrophism. (Pubmed Central) -  Mar 27, 2025   
    Although data remain limited and focused primarily on earlier SGAs, emerging findings suggest that some TGAs may exert positive effects on neuroplastic processes, including the modulation of brain-derived neurotrophic factors (BDNFs) and synaptic architecture. However, robust clinical data on their long-term effects and comparative efficacy are lacking; therefore, further research is necessary to validate their role in preventing neurodegenerative changes and improving cognitive outcomes in patients with psychiatric conditions.
  • ||||||||||  Review, Journal:  Emerging trends in antipsychotic and antidepressant drug development: Targeting nonmonoamine receptors and innovative mechanisms. (Pubmed Central) -  Jun 13, 2024   
    Additionally, TAK-653 (NBI-1065845) and MJI821 (Onfasprodil) have emerged as potential antidepressants targeting AMPA receptors and NMDA receptor 2B (NR2B) negative allosteric modulation, respectively...By focusing on nonmonoamine receptors and introducing innovative mechanisms, these drugs offer a promising prospect of improved outcomes for individuals suffering from schizophrenia and MDD. Thus, sustained attention and dedication to the development of such drugs are essential to augmenting the therapeutic options available for psychiatric patients.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Journal:  Long-term effects of Roluperidone on negative symptoms of schizophrenia. (Pubmed Central) -  May 15, 2023   
    Roluperidone was well tolerated with no meaningful changes in vital signs, laboratory values, weight gain, metabolic indices, or extrapyramidal symptoms. Results of 2 open-label extension trials support roluperidone as a treatment of negative symptoms and social functioning deficits in patients with moderate to severe negative symptoms of schizophrenia.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Latent Growth Modeling of the Efficacy of Roluperidone onNegative Symptoms and Social Functioning () -  Mar 10, 2023 - Abstract #SIRS2023SIR_240;    
    Latent variable models are adaptable to studying repeatedmeasures data when collected longitudinally at fixed time points.KeywordKeywordsNegative SymptomsPsychopharmacologyClinical trialRoluperidonePoster Award NoPlease list all co-authors for this poster submission.* Presenting AuthorFirst Name Last Name AffiliationAnthony * Ahmed * Weill Cornell Medical CollegeewYork-Presbyterian HospitalJay Saoud Minerva Neurosciences, Inc.Ramana Kuchibhatla Minerva Neurosciences, Inc.Michael Davidson Minerva Neurosciences, Inc.Consent of Release of Rights I have read and agree to the above terms and conditions.2DISCLOSUREFinancial RelationshipsDisclosure Yes, I do have financial relationship(s) to disclose.Financial Relationships DetailsCommercial Interest Type of Financial InterestMinerva Neurosciences Inc. Consultant3
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Journal:  Structures of the σ receptor enable docking for bioactive ligand discovery. (Pubmed Central) -  Apr 20, 2022   
    Here we determined the crystal structure of this receptor in complex with the clinical candidate roluperidone and the tool compound PB28...All three ligands showed time-dependent decreases in mechanical hypersensitivity in the spared nerve injury model, suggesting that the σ receptor has a role in nociception. This study illustrates the opportunities for rapid discovery of in vivo probes through structure-based screens of ultra large libraries, enabling study of underexplored areas of biology.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    A Phase 3 Trial of Roluperidone, a Drug for the Treatment of Negative Symptoms in Schizophrenia. (Cavaniglia) -  Mar 11, 2022 - Abstract #SIRS2022SIRS_55;    
    PSP total score was statistically significantly superior on roluperidone 64 mg than on placebo ( p≤ 0.021). During the 40 week of open-label drug administration negative symptoms, daily functioning, and total PANSS scores continued to improve while positive symptoms remained stable, and < 12% of the patients experienced symptom relapses during the whole 52-week study duration.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    A Phase 3 Trial of Roluperidone, a Drug for the Treatment of Negative Symptoms in Schizophrenia ([VIRTUAL]) -  Nov 28, 2021 - Abstract #ACNP2021ACNP_771;    
    Our studies demonstrate that MIN-101 modulates hippocampal and cortical-striatal circuitry in naïve rats, which has been linked to negative symptoms in SCZ. Taken together, results of this and of a previous trial indicate that roluperidone administered as monotherapy has the potential to improve negative symptoms and maintain stability or even improve the rest of the schizophrenia symptoms.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    A Phase 3 Trial of Roluperidone, a Drug for the Treatment of Negative Symptoms in Schizophrenia (Exhibit Hall C) -  Nov 28, 2021 - Abstract #ACNP2021ACNP_659;    
    Taken together, results of this and of a previous trial indicate that roluperidone administered as monotherapy has the potential to improve negative symptoms and maintain stability or even improve the rest of the schizophrenia symptoms. Taken together, results of this and of a previous trial indicate that roluperidone administered as monotherapy has the potential to improve negative symptoms and maintain stability or even improve the rest of the schizophrenia symptoms.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences, Nuplazid (pimavanserin) / Acadia Pharma
    Review, Journal:  Targeting Serotonin 5-HT Receptors to Better Treat Schizophrenia: Rationale and Current Approaches. (Pubmed Central) -  Oct 22, 2021   
    Topics include an overview of 5-HTR physiology and pathophysiology in schizophrenia, 5-HTR interaction with other neurotransmitter systems, including the glutamatergic system, a review of the 5-HTR/d-lysergic acid diethylamide (LSD) model of schizophrenia, a contrast of the 5-HTR and glutamatergic models of schizophrenia, and finally, a review of Food and Drug Administration (FDA)-approved and investigational 5-HTR-modulating compounds. Recent studies with lumeteperone, pimavanserin, and roluperidone are highlighted.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences, Caplyta (lumateperone) - Intra / Cellular Therapies, Nuplazid (pimavanserin) / Acadia Pharma
    Clinical, Review, Journal:  Novel approaches in schizophrenia-from risk factors and hypotheses to novel drug targets. (Pubmed Central) -  Jul 31, 2021   
    Substances with promising results in preclinical and clinical studies include lumateperone, pimavanserin, xanomeline, roluperidone, agonists of trace amine-associated receptor 1, inhibitors of glycine transporters, AMPA allosteric modulators, mGLUR agonists, D-amino acid oxidase inhibitors and cannabidiol. The use of anti-inflammatory agents as an add-on therapy is mentioned.
  • ||||||||||  Vraylar (cariprazine) / Mitsubishi Tanabe, Recordati, Gedeon Richter, AbbVie, roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Review, Journal:  Current perspectives in treating negative symptoms of schizophrenia: A narrative review (Review). (Pubmed Central) -  Feb 20, 2021   
    Our findings suggest that the primary negative symptoms of schizophrenia may be mitigated by adjunctive therapies, and we highlight the pharmacological agents that have proven superior efficacy. Novel compounds such as cariprazine and MIN-101, to date, show promising results, but large clinical trials are needed to test their efficacy and safety.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences, Caplyta (lumateperone) - Intra / Cellular Therapies, Nuplazid (pimavanserin) / Acadia Pharma
    Journal:  Emerging 5-HT receptor antagonists for the treatment of Schizophrenia. (Pubmed Central) -  Feb 4, 2021   
    They may also show efficacy in treating patients with milder symptoms such as patients with schizotypal personality disorder and attenuated psychosis syndrome. Their utility may also expand outside the spectrum of schizophrenia to encompass Parkinson's Disease psychosis, major depression, bipolar depression, and dementia-associated apathy.
  • ||||||||||  lurasidone oral / Generic mfg.
    Clinical, Journal:  Up-to-date Expert Opinion on the safety of recently developed antipsychotics. (Pubmed Central) -  Jan 28, 2021   
    Qualitative synthesis followed an electronic search made inquiring of the following databases: MEDLINE, Embase, PsycINFO, and the Cochrane Library from inception until March 2020, combining free terms and MESH headings for the topics of TGA and recently developed and/or marketed antipsychotics as following: ((safety OR adverse events OR side effects) AND ((brexpiprazole OR cariprazine OR inhaled loxapine OR lumateperone (ITI-007) OR lurasidone OR pimavanserin OR roluperidone (MIN-101) OR transdermal patch asenapine))...Overall, newer antipsychotics display a good safety profile, with a well-demonstrated lower metabolic liability compared to second-generation antipsychotics. Furthermore, TGA appear to specifically target negative symptomatology and improving cognitive domains.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Journal:  Biometric Analysis of Surgeons' Physiologic Responses During Surgery. (Pubmed Central) -  Jan 8, 2021   
    This data is among the first to demonstrate the negative physiological impact of surgery upon the metabolic demand of the surgeon. The longitudinal implications of increased physiologic demand over time may have cardiovascular and cerebrovascular consequences.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    [VIRTUAL] ISS.03 – Innovative strategies to treat schizophrenia (Room 1) -  Jul 10, 2020 - Abstract #ECNP2020ECNP_57;    
    Emerging Treatments for Schizophrenia The talk will discuss novel, non- dopamine receptor blocking approaches, including drugs currently in clinical trials that target muscarinic receptors, trace amine receptors, the cannabinoid system and NMDA receptors. It will present data on the mode of action of these drugs and how this relates to the neurobiology of schizophrenia, and early clinical results from trials.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Enrollment closed, Monotherapy:  Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia (clinicaltrials.gov) -  Feb 7, 2020   
    P3,  N=501, Active, not recruiting, 
    Mild to moderate symptomatic variations in the severity of symptoms during screening and more severe symptomology at baseline as measured by the PANSS were not predictive of increased risk of subsequent relapse in schizophrenic patients. Recruiting --> Active, not recruiting
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Journal:  The brief negative symptom scale (BNSS): Sensitivity to treatment effects. (Pubmed Central) -  Nov 11, 2019   
    We assessed sensitivity to change of the BNSS in a trial of MIN-101, which showed efficacy for negative symptoms (PANSS pentagonal model) at daily doses of 32 and 64mg/day...The 32mg group (N=78) did not differ significantly from placebo (N=83) on BNSS total score (ES=0.33, p<0.09), AAA (ES=0.25, p<0.20) or EXP (ES=0.30, p<0.12) scores. These results demonstrate the BNSS is sensitive to change.
  • ||||||||||  roluperidone (MIN-101) / Mitsubishi Tanabe, Minerva Neurosciences
    Trial completion:  Pharmacokinetic Study of MIN-101 in Healthy Subjects (clinicaltrials.gov) -  Feb 24, 2015   
    P1,  N=32, Completed, 
    Recruiting --> Completed Recruiting --> Completed