Radicava
Route: Intravenous infusion
Sources: FDA — Radicava approval record
Treatment
edaravone
FDA APPROVED · Radicava, Radicava ORS
FDA APPROVED
Key facts
- Generic name
- edaravone
- Brand name(s)
- Radicava, Radicava ORS
- Gene requirement
- Not gene-specific / no known gene requirement
- Genetic confirmation
- Not required by this record
- ALS population
- ALS generally; not restricted to a particular ALS gene
- Category
- ALS disease-targeting treatment
- Regulatory status
- FDA APPROVED
- FDA approval date
- 05-05-2017 (Radicava); 05-12-2022 (Radicava ORS)
- Approval pathway
- Traditional approval
- Country / availability
- United States
- Route(s)
- Intravenous infusion, Oral suspension
- Administration
- Administration details depend on formulation and individual care plan.
What is it?
A non-gene-specific ALS disease-targeting treatment with intravenous and oral-suspension formulations.
Indication: FDA records identify edaravone and Radicava ORS as indicated for the treatment of ALS in adults.
Who is it for?
ALS generally; not restricted to a particular ALS gene
How does it work?
Mechanism: Not stated in the official study record.
Target: Not stated in the official study record.
How is it administered?
Intravenous infusion, Oral suspension
The route and formulation should be reviewed with the treating clinician.
Available formulations
Radicava ORS
Route: Oral suspension; may be administered through a feeding tube
Sources: FDA — Radicava ORS approval
What evidence supported approval?
FDA records support the ALS indication for Radicava and Radicava ORS; the linked clinical source summarizes the treatment distinction and routes.
What is known about benefit?
Clinical sources describe edaravone as potentially reducing the speed of decline in daily functioning. The effect on lifespan is not established by the cited patient-facing source.
Important safety information
Edaravone has product-specific safety information and administration requirements. Review the applicable prescribing information with the treating clinician.
This page does not provide dosing, prescribing, or individualized medical advice.
Related research
Research opportunities are separate from treatment availability. Eligibility, recruitment, and study status must be confirmed in the Research record.
- No linked research record in the Research database.
Official Sources
U.S. Food and Drug Administration
FDA — Radicava approval record
A direct source for reviewing the medical, genetic, research, or policy information discussed on this page.
Retrieved: Not stated · Last verified: 09-30-2026
Previous: Not stated
New: Not stated
U.S. Food and Drug Administration
FDA — Radicava ORS approval
A direct source for reviewing the medical, genetic, research, or policy information discussed on this page.
Retrieved: Not stated · Last verified: 09-30-2026
Previous: Not stated
New: Not stated
Mayo Clinic
Amyotrophic lateral sclerosis — Diagnosis and treatment
A direct source for reviewing the medical, genetic, research, or policy information discussed on this page.
Retrieved: Not stated · Last verified: 09-30-2026
Previous: Not stated
New: Not stated
Last verified: 09-30-2026
Treatment information is provided for education and navigation and does not replace medical advice. Whether a treatment is appropriate depends on the individual’s diagnosis, genetic status, symptoms, health status, and other clinical factors. Treatment decisions should be made with the person’s ALS care team.