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Details:

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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 27, 2024

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH

Deal Size: $20.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement June 28, 2023

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2023

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 01, 2023

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 17, 2022

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 22, 2022

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2022

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Details:

Roluperidone at both doses was safe and well tolerated, and treatment-emergent adverse events (TEAE) were generally mild to moderate in severity.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2021

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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.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: MIN-101

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 01, 2020

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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 Score.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

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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 Score.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

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Details:

A total of 515 patients have been randomized in this trial, compared to the original goal of 501 patients. The trial, which is being conducted at clinical sites in the U.S. and Europe.


Lead Product(s): Roluperidone

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 05, 2020

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