Product Description
Safinamide (Xadago®) is an orally active, selective, reversible monoamine oxidase-B inhibitor with both dopaminergic and non-dopaminergic (glutamatergic) properties. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28110399/)
Mechanisms of Action: MAO-b Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Colombia | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Philippines | Poland | Portugal | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Newron
Company Location:
Company Founding Year: 1999
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
Highest Development Phases
Phase 1: Parkinson's Disease
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
CTR20253904 |
CTR20253904 | P1 |
Completed |
Parkinson's Disease |
2025-09-25 |
2025-12-14 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/16/2026 |
News Article |
Newron Secures Up to EUR 38 Million to Advance Phase III Evenamide Program |
|
02/03/2026 |
News Article |
Newron Notes Publication Highlighting Clinically Meaningful Benefits of Evenamide as an Adjunctive Treatment in Schizophrenia |
|
01/07/2026 |
News Article |
EA Pharma, a subsidiary of Eisai, Announces the Initiation of its Phase III Clinical Trial with Evenamide, a Novel Treatment for Schizophrenia, in Japan |
|
01/06/2026 |
News Article |
Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent |