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Minerva Neurosciences (NERV)
NASDAQ:NERV
Roluperidone 64 Mg, Olanzapine 10 Mg
Negative Symptoms In Schizophrenia
Phase I
Completed
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
Oct 13, 2023
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Min-117 5.0 Mg, Min-117 2.5 Mg
Major Depressive Disorder
Phase II
Completed
A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder
Feb 20, 2018
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Roluperidone 32 Mg, Roluperidone 64 Mg
Negative Symptoms Of Schizophrenia
Phase III
Completed
Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia
Dec 29, 2017
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Min-101
Healthy Subjects
Phase I
Completed
A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers
Feb 23, 2017
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Min-101
Healthy Subjects
Phase I
Completed
A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects
Jan 10, 2017
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Minerva Neurosciences (NERV) have in its pipeline
NERV is currently developing the following drugs: Roluperidone 64 Mg, Olanzapine 10 Mg, Min-117 5.0 Mg, Min-117 2.5 Mg, Roluperidone 32 Mg, Roluperidone 64 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.