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Rilutek (RILUZOLE)
Rilutek (Riluzole) is a small molecule benzothiazole drug developed by Covis Pharma SARL and currently owned by Covis. It targets the sodium-dependent noradrenaline transporter and is FDA-approved since 1995 for the treatment of Amyotrophic Lateral Sclerosis (ALS). Rilutek is off-patent and has multiple generic manufacturers. It has a half-life of 12 hours and bioavailability of 64%. Key safety considerations include its potential to cause liver enzyme elevations and gastrointestinal side effects.
At a glance
| Generic name | RILUZOLE |
|---|---|
| Sponsor | Covis |
| Drug class | Benzothiazole [EPC] |
| Target | Sodium-dependent noradrenaline transporter |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1995 |
Approved indications
- Amyotrophic lateral sclerosis
Common side effects
- Asthenia
- Nausea
- Dizziness
- Decreased lung function
- Abdominal pain
Serious adverse events
- Hepatic injury
- Acute hepatitis
- Icteric toxic hepatitis
- Neutropenia
- Interstitial lung disease
- Pancreatitis
- Renal tubular impairment
Key clinical trials
- Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma (PHASE1)
- Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids (PHASE2)
- Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial (PHASE2)
- Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS) (PHASE1,PHASE2)
- PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS (PHASE2)
- Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control
- Y-4 to Treat the Postherpetic Neuralgia (PHASE2)
- MIROCALS: Modifying Immune Response and OutComes in ALS (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8765150 | 2029-03-12 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rilutek CI brief — competitive landscape report
- Rilutek updates RSS · CI watch RSS
- Covis portfolio CI