Radicava (edaravone)
Also marketed as Radicava ORS. An approved treatment for Amyotrophic Lateral Sclerosis.
The same compound appears under different names depending on the context. Here is how to identify Edaravone wherever you encounter it, plus the key facts at a glance.
- Generic name
- Edaravone
- Brand names
- Radicava, Radicava ORS
- Development codes
- MCI-186, MT-1186
- International name
- Radicut (Japan)
- Drug class
- Antioxidant neuroprotectant
- Manufacturer
- Shionogi (acquired from Tanabe Pharma in April 2026)
- How it's taken
- IV Radicava: 60 mg by intravenous infusion over 60 minutes.
A free radical scavenger that protects motor neurons from oxidative stress damage. In the US it is now sold as an oral suspension (Radicava ORS); the brand IV form was discontinued in 2025, but generic IV edaravone is available. It was the second drug approved for ALS and works by a completely different mechanism than riluzole.
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Where Edaravone fits
Add-on therapy used alongside riluzole for ALS patients, particularly those in earlier disease stages. Originally developed and approved in Japan for stroke before its ALS indication.
How Edaravone works
In ALS, motor neurons are damaged by harmful molecules called free radicals that build up from oxidative stress. Edaravone is an antioxidant that is thought to neutralize these free radicals before they can damage nerve cells, although exactly how it works in ALS is not known.
It scavenges both water-soluble and fat-soluble harmful molecules, protecting cell membranes and internal structures. By reducing oxidative damage, it helps slow the rate of functional decline, particularly in early-stage ALS.
Mechanism: Free radical scavenger that neutralizes reactive oxygen species to protect motor neurons from oxidative stress damage
Side effects and safety
Common side effects include bruising, gait disturbance, headache, and fatigue. Serious but rare hypersensitivity reactions can occur, including swelling and breathing difficulty. Radicava and Radicava ORS contain sodium bisulfite, a sulfite that can cause serious allergic reactions, including life-threatening asthma attacks, in people who are sensitive to sulfites (this is more common in people with asthma).
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Edaravone
IV Radicava: 60 mg by intravenous infusion over 60 minutes. First cycle is 14 consecutive daily infusions followed by 14 days off. Subsequent cycles are 10 infusions over 14 days followed by 14 days off. Oral Radicava ORS: 105 mg (5 mL) once daily by mouth or feeding tube, taken in the morning after an overnight fast, with no food (except water) for 1 hour after, following the same cycle pattern. Brand IV Radicava was discontinued in the US in 2025; generic IV edaravone is still available.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Small-molecule drug requiring either intravenous infusion cycles or a specialized oral suspension formulation. Orphan drug designation for a rare disease.
Help paying for Radicava
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Out-of-Pocket Savings Program: eligible commercially insured patients (age 18 or older, living in the US or a US territory) may pay as little as $0 per Radicava ORS prescription, up to an annual maximum benefit. Not for people with Medicare Part C or D, Medicaid, VA, DoD, TRICARE or other government insurance (Medicare Part A/B with commercial drug coverage is allowed).
For: private insurance · source - Free medicine program
Patient Assistance Program: uninsured people in financial need (household income up to 5 times the Federal Poverty Level, ages 18 to 65, US citizen or permanent resident, no government insurance) may get Radicava ORS at no charge for up to 2 years (eligibility rechecked after the first 12 months). Only the medicine is covered, not doctor visits.
For: no insurance · source - Insurance and case manager help
JourneyMate Support Program: Insurance & Access Specialists (1-844-772-4548, Monday to Friday, 8 AM to 8 PM ET) check coverage, explain cost-saving options and coordinate with the specialty pharmacy; Resource Specialists and ALS Clinical Educators provide education about ALS and Radicava ORS.
The official page does not say who qualifies. Ask the program. · source
Good to know: Enroll through a Benefit Investigation and Enrollment Form signed by you and your doctor, a signed Patient Authorization Form, or the Out-of-Pocket Savings Program Enrollment Form (fax 1-888-782-6157). The online copay portal was listed as unavailable in September 2026, so call 1-844-772-4548 for help enrolling. Brand IV Radicava was discontinued in 2025, and current program terms cover Radicava ORS.
- From a charity · HealthWell FoundationAmyotrophic Lateral Sclerosis fundOpen
Pays for: Copays, premiums or other treatment costs.
- From a charity · NORD RareCareALS Travel & Lodging Assistance fundOpen
Pays for: Travel and lodging for care.
The foundation says: “Accepting Applications” - From a charity · Muscular Dystrophy AssociationMDA Durable Medical Equipment (DME) Grant Program fundApply directly
Pays for: Medical equipment (wheelchairs, lifts, canes and other DME), up to $1,000 per year.
The foundation says: “Status not shown on page” - From a charity · The ALS AssociationHoffman ALS Financial Assistance Program fundApply directly
Pays for: Travel to ALS clinic (transportation, lodging, lost wages) and clinic copays/deductibles, up to $1,000 per year.
The foundation says: “Status not shown on page” - From a charity · The Assistance FundAmyotrophic Lateral Sclerosis (ALS) fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
The pivotal Japanese trial (Study 19, NCT01492686) enrolled 137 early-stage ALS patients and showed edaravone significantly slowed functional decline compared to placebo over 24 weeks. An earlier, broader Phase 3 trial of 206 patients did not show a clear benefit, and a small study in people with more advanced ALS also showed no benefit, suggesting it works best in people with early, definite or probable ALS.
Development history
Developed by Mitsubishi Tanabe Pharma in Japan over 13 years of ALS-focused research. First approved in Japan and South Korea in 2015, then by the FDA in May 2017 as the second-ever ALS medication. The oral suspension (Radicava ORS) was approved in May 2022. The brand IV form was discontinued in the US in 2025, and Shionogi bought all rights to Radicava from Tanabe Pharma in April 2026.
Explore Amyotrophic Lateral Sclerosis trials
Other Amyotrophic Lateral Sclerosis treatments
Common questions about Edaravone
▸What is Edaravone (Radicava)?
A free radical scavenger that protects motor neurons from oxidative stress damage. In the US it is now sold as an oral suspension (Radicava ORS); the brand IV form was discontinued in 2025, but generic IV edaravone is available. It was the second drug approved for ALS and works by a completely different mechanism than riluzole.
▸How does Edaravone work?
In ALS, motor neurons are damaged by harmful molecules called free radicals that build up from oxidative stress. Edaravone is an antioxidant that is thought to neutralize these free radicals before they can damage nerve cells, although exactly how it works in ALS is not known.
It scavenges both water-soluble and fat-soluble harmful molecules, protecting cell membranes and internal structures. By reducing oxidative damage, it helps slow the rate of functional decline, particularly in early-stage ALS.
▸What are the side effects of Edaravone?
Common side effects include bruising, gait disturbance, headache, and fatigue. Serious but rare hypersensitivity reactions can occur, including swelling and breathing difficulty. Radicava and Radicava ORS contain sodium bisulfite, a sulfite that can cause serious allergic reactions, including life-threatening asthma attacks, in people who are sensitive to sulfites (this is more common in people with asthma).
▸How is Edaravone taken?
IV Radicava: 60 mg by intravenous infusion over 60 minutes. First cycle is 14 consecutive daily infusions followed by 14 days off. Subsequent cycles are 10 infusions over 14 days followed by 14 days off. Oral Radicava ORS: 105 mg (5 mL) once daily by mouth or feeding tube, taken in the morning after an overnight fast, with no food (except water) for 1 hour after, following the same cycle pattern. Brand IV Radicava was discontinued in the US in 2025; generic IV edaravone is still available.
▸Is Edaravone FDA approved?
Yes, Edaravone (Radicava) is FDA approved (2017) for the treatment of Amyotrophic Lateral Sclerosis.
▸What is the difference between IV Radicava and oral Radicava ORS?
Both contain the same active ingredient (edaravone) and follow the same treatment cycle pattern, but they differ in how they are given. IV Radicava is given as an infusion into a vein over 60 minutes per dose. Oral Radicava ORS is a liquid suspension taken by mouth once daily at home. The oral version was approved in May 2022. The brand IV Radicava was discontinued in the US in 2025, though generic IV edaravone is still available. Radicava ORS must be taken in the morning after an overnight fast, with no food for 1 hour after the dose. The oral dose is 105 mg compared to 60 mg IV, adjusted to achieve similar drug levels in the body.
▸Does edaravone work for all stages of ALS?
Clinical trial data suggests edaravone works best in patients with early, definite or probable ALS who still have relatively preserved function. The pivotal trial (Study 19) specifically enrolled people who had had ALS for 2 years or less, could still do most daily activities, and had normal breathing function. An earlier, broader trial and a small study in people with more advanced ALS did not show a clear benefit. This does not necessarily mean it cannot help patients at later stages, but the strongest evidence supports early use.
▸What does the edaravone treatment cycle look like?
The first treatment cycle consists of daily doses for 14 consecutive days, followed by 14 days off. All subsequent cycles are 10 doses given over a 14-day period (typically weekdays), followed by 14 days off. This on-off pattern continues indefinitely. The cycling schedule applies to both the IV and oral formulations. Many patients find it helpful to mark their treatment calendar in advance.
▸Why did earlier edaravone trials fail?
Edaravone was tested in 2 earlier placebo-controlled trials in Japan before the successful pivotal trial (Study 19). The first, a Phase 3 trial of 206 people with a broader range of ALS, did not show a statistically significant benefit. The second was a small exploratory study of 25 people with more advanced ALS, which also showed no benefit. Study 19 succeeded by focusing on a more specific patient group: people with definite or probable ALS for 2 years or less, who could still do most daily activities and had normal breathing function. This taught researchers that patient selection is critical for demonstrating edaravone's benefit.
▸Can edaravone be used with riluzole?
Yes. Edaravone and riluzole target different mechanisms (oxidative stress vs. glutamate toxicity) and are commonly prescribed together. In clinical trials, most patients were already taking riluzole when they started edaravone. There are no known drug interactions between the two.
▸What financial assistance is available for edaravone?
Shionogi, which now owns Radicava, offers the JourneyMate Support Program, which helps with insurance questions, cost-saving options, and treatment education. Copay assistance is available for commercially insured patients, and uninsured patients may qualify to receive the medication at no cost. You can reach a JourneyMate Insurance & Access Specialist at 1-844-772-4548 (Monday to Friday, 8 AM to 8 PM ET) or learn more at radicava.com.
▸Was edaravone originally developed for ALS?
No. Edaravone was originally developed and approved in Japan for acute ischemic stroke (marketed as Radicut). Its free radical scavenging properties were later investigated in ALS, where oxidative stress is believed to contribute to motor neuron damage. Mitsubishi Tanabe Pharma conducted over 13 years of ALS-specific research before the drug received ALS approval in Japan in 2015 and in the U.S. in 2017.