[{"orgOrder":0,"company":"Minerva Neurosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Minerva Completes Patient Enrollment in Roluperidone Study","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Minerva Neurosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 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Market","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Minerva Neurosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Minerva Neurosciences Provides Update from Type C Meeting with FDA and Next Steps in Preparation for Submission of a New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Minerva Neurosciences","sponsor":"Not 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Find Clinical Drug Pipeline Developments & Deals for Roluperidone Hydrochloride
MIN-101 (roluperidone) has been shown to block serotonin, sigma and α-adrenergic receptors that are all involved in the regulation of important brain functions. It is being evaluated for the treatment of negative symptoms in patients with schizophrenia.
Minerva intends to use the net proceeds to support potential regulatory approval in the U.S., commercialization activities and market launch of MIN-101 (roluperidone), which is being developed for the treatment of negative symptoms in schizophrenia.
MIN-101 (roluperidone) is an investigational drug that has been shown to block serotonin, sigma and α-adrenergic receptors that are all involved in the regulation of important brain functions, including mood, cognition, sleep, and anxiety.
MIN-101 (roluperidone) is a compound that has been shown to block serotonin, sigma and α-adrenergic receptors that are involved in the regulation of mood, cognition, sleep and anxiety. It is being developed to treat the negative symptoms of patients with schizophrenia.
Roluperidone (MIN-101) has been designed to block a specific subtype of serotonin receptor called 5-HT2A. When 5-HT2A is blocked, certain symptoms of schizophrenia, such as hallucinations, delusions, agitation and thought and movement disorders.
The MIN-101 (roluperidone) clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.
MIN-101 (roluperidone) is a compound that has been shown to block serotonin, sigma and α-adrenergic receptors that are involved in the regulation of mood, cognition, sleep and anxiety to treat negative symptoms of patients with schizophrenia.
The objective of this meeting was to obtain FDA input regarding the roluperidone data package and its readiness to support a New Drug Application (NDA) submission.
The 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score, or the key secondary endpoint, the Personal and Social Performance Scale Total Score.
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