Riluzole
As of the edition of 20 October 2026, Riluzole is a small molecule: marketed, first approved in 1995 (US); acts on SCN10A, SCN11A and SCN1A and 7 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Rilutek
- First approved
- 12 December 1995 (US)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- Aquestive Therapeutics; 8 holders in all
- Registered trials
- 67, 7 stopped early
- Disease areas
- Nervous system; Nutrition and metabolism; Mental health; Cancer; Inherited and neonatal; Skin and connective tissue
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Riluzole.
See the 9 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 4 | 0 | 0 |
| Phase 1 | 15 | 7 | 4 | 3 |
| Phase 2 | 26 | 16 | 6 | 2 |
| Phase 3 | 15 | 9 | 3 | 2 |
| Phase 4 | 5 | 5 | 0 | 0 |
| All trials | 67 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 1995 to now |
| Zentiva k.s | Later holder | 2012 to now |
| Italfarmaco | Later holder | 2018 to now |
| Aquestive Therapeutics | Later holder | 2019 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |