NDAORALFILM
Approved
Nov 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
EXSERVAN (riluzole) by Italfarmaco Research is 12. Approved for amyotrophic lateral sclerosis. First approved in 2019.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXSERVAN (riluzole) is an oral film formulation of riluzole approved in 2019 for amyotrophic lateral sclerosis (ALS) and under investigation for multiple neurological and oncological indications including spinocerebellar ataxia, Huntington's disease, and glioblastoma. The mechanism of action in ALS remains unknown, though riluzole is thought to modulate glutamate neurotransmission. It is currently at peak commercial lifecycle.
$0.409MPart D
PeakMinimal commercial footprint with only 126 Part D claims suggests limited market penetration; brand team likely small and focused on rare disease stakeholder engagement.
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 (1)
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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.