Safinamide mesylate is under clinical development by Newron Pharmaceuticals and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Safinamide mesylate’s likelihood of approval (LoA) and phase transition for Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration) took place on 13 Jan 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Safinamide mesylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Safinamide mesylate overview

Safinamide mesylate (Xadago,Equfina ) is an alpha-aminoamide derivative act as add-on therapy to dopamine agonists or levodopa. It is formulated as film-coated tablets for oral route of administration. Xadago is indicated in the treatment of idiopathic Parkinson's disease (PD) or for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products.

It is under development for the treatment of multiple system atrophy (MSA), levodopa-induced dyskinesia and Parkinson's disease in Israel and Mexico. It was also under development for the treatment of restless legs syndrome and amyotrophic lateral sclerosis.

Newron Pharmaceuticals overview

Newron Pharmaceuticals is a research-based biopharmaceutical company that focuses on the discovery, development, and commercialization of novel therapeutic drugs for the treatment of central nervous system disorders and pain. The company’s marketed product, Xadago (safinamide), is developed as an adjunctive therapy for any stage of Parkinson’s disease. Newton’s other products in the pipeline include ralfinamide for neuropathic pain; sarizotan for Rett syndrome; and Evenamide (NW-3509) for the treatment of schizophrenia. The company has development and commercialization collaborations with Zambon and Meiji Seika Pharma Co Ltd. It operates along with its subsidiaries in the UK, Switzerland, Sweden, and the US. Newron is headquartered in Bresso, Milan, Italy.

Quick View Safinamide mesylate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Safinamide mesylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.