Drug profile · INN
safinamide
ARX-SAFINAMIDE
safinamide (ARX-SAFINAMIDE) is a monoamine oxidase b inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
Drug details — safinamide
- US status
- approved
- Class
- Nervous system (N04)
- Route
- ORAL
- Patents
- 0
- Programs
- 1
- Data quality
- 0.84
Quick answer
safinamide (ARX-SAFINAMIDE) is a monoamine oxidase b inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
Monoamine oxidase B inhibitor
Primary target: Amine oxidase [flavin-containing] B
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is safinamide?
safinamide (ARX-SAFINAMIDE) is a monoamine oxidase b inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for safinamide?
ARX-SAFINAMIDE is a marketed brand name for safinamide. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of safinamide?
safinamide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.