Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Minerva Receives Complete Response Letter from FDA for Roluperidone NDA
Details : MIN-101 (roluperidone) blocks serotonin, sigma, and α-adrenergic receptors, involved in brain function regulation, and is being evaluated for treating negative symptoms in schizophrenia patients.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 27, 2024
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Boehringer Ingelheim GmbH
Deal Size : $20.0 million
Deal Type : Private Placement
Minerva Neurosciences Announces $20 Million in Private Placement Priced at a Premium to Market
Details : 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.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 28, 2023
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Boehringer Ingelheim GmbH
Deal Size : $20.0 million
Deal Type : Private Placement
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 11, 2023
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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 wit...
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 01, 2023
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 17, 2022
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 22, 2022
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 07, 2022
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Roluperidone at both doses was safe and well tolerated, and treatment-emergent adverse events (TEAE) were generally mild to moderate in severity.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 11, 2021
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : MIN-101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 01, 2020
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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 Scor...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 29, 2020
Lead Product(s) : Roluperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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