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Newron Pharmaceuticals SpA (NWPHF)
OTHER OTC:NWPHF
Evenamide
Schizophrenia
Phase II
Completed
Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia
Jun 19, 2020
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Evenamide
Healthy
Phase I
Unknown
An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects
Jan 29, 2018
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Sarizotan Low Dose, Sarizotan High Dose
Rett Syndrome
Phase II/III
Terminated
Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms
May 24, 2016
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Nw-3509A
Chronic Schizophrenia
Phase II
Completed
A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia
Nov 20, 2015
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Nw-3509A
Schizophrenia
Phase I
Completed
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
Aug 21, 2013
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Safinamide
Parkinson Disease
Phase II
Terminated
A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging
Dec 20, 2010
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Ralfinamide
Pain
Phase III
Completed
Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain
Nov 23, 2009
―
Safinamide
Parkinson's Disease
Phase III
Terminated
Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients
Mar 10, 2009
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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 Newron Pharmaceuticals SpA (NWPHF) have in its pipeline
NWPHF is currently developing the following drugs: Evenamide, Evenamide, Sarizotan Low Dose, Sarizotan High Dose. These drug candidates are in various stages of clinical development as the company works toward FDA approval.