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: None *
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: Parkinson Disease
Known Adverse Events: Insomnia
Company: Newron
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Italy, Spain
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Parkinson's Disease
Phase 2: Multiple System Atrophy|Shy-Drager Syndrome
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SteP-on | P3 |
Active, not recruiting |
Unknown |
2022-12-17 |
|
| Z7219J03 | P1 |
Completed |
Healthy Volunteers |
2021-08-20 |
|
| Z7219L05 | P3 |
Completed |
Parkinson's Disease |
2021-08-20 |
|
| Safinamide for Multiple System Atrophy | P2 |
Completed |
Multiple System Atrophy |
2021-01-05 |