NDAORALTABLETPriority Review
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
RILUTEK (riluzole) by Italfarmaco Research is 12. First approved in 1995.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RILUTEK (riluzole) is a small-molecule oral tablet approved in 1995 for amyotrophic lateral sclerosis (ALS). The exact mechanism of action remains unknown, though it is believed to modulate glutamate neurotransmission. It is administered orally and represents one of the first disease-modifying therapies for ALS.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team contraction and shift toward generic defense strategies.
Mechanism of Action
12.1 Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown. 12.2 Pharmacodynamics The clinical pharmacodynamics of riluzole has not been determined in humans. 12.3 Pharmacokinetics Table 2 displays the pharmacokinetic parameters of…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.