Riluzole
Approved · EMAAlso known as Exservan, Rilutek, Teglutik, Tiglutik+2 more
Exservan, Rilutek, Teglutik, Tiglutik, Riluzol, Riluzolum.
Recent clinical, regulatory, research and industry developments relating to this drug.
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
Approval: Riluzole Zentiva (EMA)
Open-label riluzole in fragile X syndrome.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that… Show full indicationShow less
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.
Indication: Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Rilutek… Show full indicationShow less
Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Rilutek extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Rilutek has not been shown to be effective in the late stages of ALS. Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes1
Journals, researchers & institutions
- Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2
- Brain : a journal of neurology1
- Brain research1
- Pigment cell & melanoma research1
- Andrews RD1
- Brennan BP1
- Chen S1
- Cohen BM1
- David Mozley P1
- Dowd K1
- Dudek L1
- Erickson CA1
- Alzheimer's Disease Research Center1
- Alzheimer's Drug Discovery Foundation1
- Biological Psychiatry Laboratory1
- Brigham and Women's Hospital1
- Friedman Brain Institute1
- Indiana University School of Medicine1
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.