Safinamide
As of the edition of 20 October 2026, Safinamide is a small molecule: marketed, first approved in 2015 (EU); acts on MAOB; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Xadago
- First approved
- 23 February 2015 (EU)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Meiji Seika Pharma; 3 holders in all
- Registered trials
- 21, 4 stopped early
- Disease areas
- Nervous system; Blood and lymph; Cancer; Chemically induced; Digestive system; Immune system
US protection
US protection ends in 2028.
The last listed US drug-substance patent ends in 2028. The application that gives this date is held by Supernus Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Safinamide.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MAOB | Amine oxidase [flavin-containing] B | P27338 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 8 | 6 | 0 | 2 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Zambon | Applicant and Lead sponsor of trials | 2015 to now |
| Supernus Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2017 to now |
| Meiji Seika Pharma | Applicant | 2019 to now |