Newron Pharmaceuticals SpA (NWPHF) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Evenamide 15 Mg Bid | Treatment-Resistant Schizophrenia | Phase III | Not Yet Recruiting | Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia | Sep 18, 2025 | ― |
| Evenamide | Schizophrenia | Phase II | Completed | Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia | Jun 19, 2020 | ― |
| Evenamide | Healthy | Phase I | Unknown | An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects | Jan 29, 2018 | ― |
| Sarizotan Low Dose, Sarizotan High Dose | Rett Syndrome | phase2AndPhase3 | Terminated | Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms | May 24, 2016 | ― |
| 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 | ― |
| Nw-3509A | Schizophrenia | Phase I | Completed | A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers. | Aug 21, 2013 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Evenamide 15 Mg Bid | Phase III | Treatment-Resistant Schizophrenia | Not Yet Recruiting | Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia | Sep 18, 2025 | ― |
| Evenamide | Phase II | Schizophrenia | Completed | Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia | Jun 19, 2020 | ― |
| Evenamide | Phase I | Healthy | Unknown | An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects | Jan 29, 2018 | ― |
| Sarizotan Low Dose, Sarizotan High Dose | phase2AndPhase3 | Rett Syndrome | Terminated | Evaluation of the Efficacy, Safety, and Tolerability of Sarizotan in Rett Syndrome With Respiratory Symptoms | May 24, 2016 | ― |
| Nw-3509A | Phase II | Chronic Schizophrenia | Completed | A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia | Nov 20, 2015 | ― |
| Nw-3509A | Phase I | Schizophrenia | Completed | A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers. | Aug 21, 2013 | ― |
| Safinamide | Phase II | Parkinson Disease | Terminated | A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging | Dec 20, 2010 | ― |
| Ralfinamide | Phase III | Pain | Completed | Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back Pain | Nov 23, 2009 | ― |
| Safinamide | Phase III | Parkinson's Disease | Terminated | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Mar 10, 2009 | ― |
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
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
Newron Pharmaceuticals SpA NWPHF is currently developing the following drugs: Evenamide 15 Mg Bid, Evenamide, Sarizotan Low Dose, Sarizotan High Dose, Nw-3509A, Safinamide, Ralfinamide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.