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Safinamide

Alternative Names: safinamide, xadago
Latest Update: 2024-06-25
Latest Update Note: News Article

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

Map of Global Clinical Trials for Safinamide

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

Z7219L05

P3

Completed

Parkinson's Disease

2021-08-20

Z7219J03

P1

Completed

Healthy Volunteers

2021-08-20

Safinamide for Multiple System Atrophy

P2

Completed

Multiple System Atrophy

2021-01-05

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