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Safinamide - Newron Pharmaceuticals

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: 05 Nov 2023

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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

  • 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
  • 07 Oct 2021 Zambon completed the phase III trial in Parkinson's disease (Treatment-experienced, Adjunctive treatment) in China (PO) (NCT03881371)
  • 16 Sep 2021 Newron Pharmaceuticals and Zambon plan a study to demonstrate the anti-dyskinetic effect of safinamide in Parkinson’s disease patients with Levodopa Induced Dyskinesia in USA, Europe, Asia, Australia in the fourth quarter of 2022
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