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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: 11 Jun 2024

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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

  • 11 Jun 2024 Regulatory body accepts MAA for Safinamide for Parkinson’s disease for review
  • 05 Jun 2024 Preregistration for Parkinson's disease in Latin America (PO), prior to June 2024
  • 14 Mar 2023 Newron and Zambon have reached an agreement to discontinue their plans to initiate a clinical study with safinamide in Parkinson’s disease

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