[{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Announces Initiation of New Clinical Trial With Evenamide in Patients With Schizophrenia, Following Approval of Plan By FDA","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Updates On STARS Study FDA Interaction","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 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Patient","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Presents Encouraging Interim Results for Evenamide in Patients with Treatment-Resistant Schizophrenia (TRS) at the 33rd CINP Hybrid World Congress of Neuropsychopharmacology","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Announces Striking Six-Month Interim Results from its Exploratory Clinical Trial Evaluating Evenamide as Add-On Therapy for Patients with Treatment-Resistant Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Reports Striking One-Year Interim Efficacy Results From Its Phase II Clinical Trial Evaluating Evenamide as Add-On Therapy for Patients With Treatment-Resistant Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular 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Evenamide","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Reports Exceptional One-year Results of Study 014\/15 With Evenamide in Treatment-resistant Schizophrenia (TRS)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Newron Pharmaceuticals
NW3509 (evenamide) is an orally available new chemical entity, specifically blocks voltage-gated sodium channels and is devoid of biological activity at >130 other CNS targets. It is under phase 2 clinical development for the treatment of Treatment-resistant Schizophrenia.
NW3509 (evenamide) is an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It is under phase 2 clinical development for the treatment of Schizophrenia.
NW-3509 (evenamide) is an orally available new chemical entity, specifically blocks voltage-gated sodium channels. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.
NW-3509 (evenamide), an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs). It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.
NW-3509 (Evenamide), an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs). It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.
The data presented confirm NW-3509 (evenamide) potential to improve symptoms of psychosis in patients who, despite treatment with various antipsychotics, continue to experience severe symptoms of psychosis and functional disabilities.
Under the agreement, Newron will sponsor the study and be responsible for Xadago (safinamide), development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.
Explanatory study 008 is designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed doses of evenamide (7.5 mg and 15 mg BID) in patients with chronic schizophrenia under treatment with a leading second-generation atypical antipsychotics.
All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021.
Results from STRIDE 3 short-term treatment of dry eye disease, along with the positive data from the previous clinical trials of EYSUVIS served as the basis for Kala’s NDA resubmission package.