Safinamide - Newron Pharmaceuticals

Drug Profile

Safinamide - Newron Pharmaceuticals

Alternative Names: EMD 1195686; FCE 26743; ME 2125; NW 1015; PNU 151774; PNU 151774E; Safinamide mesilate; Safinamide mesylate; Xadago; ZP-034

Latest Information Update: 24 Mar 2018

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At a glance

  • Originator Pfizer
  • Developer Meiji Seika Pharma; Newron Pharmaceuticals; US WorldMeds; Zambon SpA
  • Class Amides; Antidementias; Antiepileptic drugs; Antiparkinsonians; Benzylamines; Fluorobenzenes; Neuroprotectants; Small molecules
  • Mechanism of Action Calcium channel antagonists; Dopamine uptake inhibitors; Glutamate-release-inhibitors; Monoamine oxidase B inhibitors; Sodium channel antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Parkinson's disease
  • No development reported Drug-induced dyskinesia
  • Discontinued Alzheimer's disease; Epilepsy; Restless legs syndrome

Most Recent Events

  • 13 Sep 2018 Meiji Seika Pharma announces intention to submit a marketing authorization application for Parkinson's disease in Japan in the second half of 2018
  • 24 Jun 2018 Biomarkers information updated
  • 01 Mar 2018 Preregistration for Parkinson's disease (Adjunctive treatment, Early-stage disease) in Brazil, Colombia (PO) before March 2018
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