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Safinamide - Newron Pharmaceuticals

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Drug Profile

Safinamide - Newron Pharmaceuticals

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

Latest Information Update: 06 Feb 2025

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At a glance

  • Originator Pfizer
  • Developer Eisai Co Ltd; Meiji Seika Pharma; Merck Serono; 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
  • Phase II Drug-induced dyskinesia; Multiple system atrophy
  • Discontinued Alzheimer's disease; Epilepsy; Restless legs syndrome

Most Recent Events

  • 29 Jan 2025 Safinamide licensed to Zambon SpA in China
  • 29 Jan 2025 Registered for Parkinson's disease (Adjunctive treatment, Treatment-experienced) in China (PO)
  • 29 Jan 2025 Meiji Seika Pharma announces intention to launch safinamide for Parkinson’s disease in China in the second quarter of 2025

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