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Safinamide - Newron Pharmaceuticals

Drug Profile

Safinamide - Newron Pharmaceuticals

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

Latest Information Update: 17 Jan 2019

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At a glance

  • Originator Pfizer
  • Developer Meiji Seika Pharma; Newron Pharmaceuticals; US WorldMeds; Valeo Pharma; Zambon SpA
  • Class Amides; Antidementias; Antiepileptic drugs; Antiparkinsonians; Benzylamines; Fluorobenzenes; Neuroprotectants; Small molecules
  • Mechanism of Action Monoamine oxidase B inhibitors
  • Orphan Drug Status

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

    No
  • 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

  • 15 Jan 2019 Registered for Parkinson's disease (Adjunctive treatment, Early-stage disease, Late-stage disease, Mid-stage disease) in Canada (PO)
  • 30 Nov 2018 Registered for Parkinson's disease (Adjunctive treatment, Late-stage disease, Mid-stage disease) in Australia (PO)
  • 27 Nov 2018 Zambon plans a phase II trial for Parkinsonian-disorders in March 2019 (NCT03753763)
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