NDAORALSUSPENSIONPriority Review
Approved
May 2022
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
9
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RADICAVA ORS is an oral suspension formulation of edaravone, a small-molecule free radical scavenger approved for amyotrophic lateral sclerosis (ALS). It represents a convenient oral alternative to the intravenous formulation, potentially expanding patient accessibility and compliance. The drug works by reducing oxidative stress implicated in neuronal degeneration.
$294MPart D
PeakStable
15.4 years to LOEProduct is at commercial peak with substantial Part D utilization, indicating robust team sizing and resource allocation for marketing and field operations.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
Started Aug 2025
600 enrolled
Cerebral Small Vessel DiseaseIschemic Stroke
ASURE: Alzheimer Study Using oRal Edaravone
Started Mar 2023
61 enrolled
Alzheimer Disease
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
Started Jan 2022
202 enrolled
ALS
Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis
Started Oct 2021
313 enrolled
Amyotrophic Lateral Sclerosis
Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
Started Nov 2020
384 enrolled
ALS
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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.