XADAGO safinamide

Drug Class

Monoamine oxidase B (MAO-B) inhibitor

Mechanism

Safinamide is a highly selective and reversible monoamine oxidase B (MAO-B) inhibitor that increases dopamine levels; it also modulates glutamate release and sodium/calcium channels.

Approved Indication

Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' episodes.

What This Means For Patients

Xadago (safinamide) is an add-on therapy for Parkinson's disease designed to reduce 'off' episodes. It works via a dual dopaminergic and non-dopaminergic mechanism to optimize levodopa therapy and improve motor function. Following approvals by the FDA, EMA, and China NMPA, it is available for patients in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2017) — label
• EMA — approved (2015) — source
• NMPA — approved (2025) — source

Pivotal Clinical Evidence

• SETTLE — Schapira et al., JAMA Neurol 2017 (NCT00627640) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208583s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/xadago
• https://www.meiji.com/