Approved
Edaravone
Also known as Radicava, Radicava ORS, Radicut, MCI-186, MT-1186
Bottom line
One six-month trial in carefully chosen early-stage patients showed slower decline. An earlier, broader trial and a large independent German study found no benefit, and Europe's regulator was not convinced. Whether it helps over the long term is unproven.
Edaravone is an antioxidant approved for ALS in Japan and South Korea (2015), the USA (2017) and several other countries, but not in the European Union. Its approval rests on one six-month Japanese trial in carefully chosen early-stage patients; its first Phase 3 trial missed its goal, a large independent German study found no benefit in everyday care, and Europe's regulator was not convinced. It is given in on/off cycles, as an oral liquid (Radicava ORS) or an intravenous drip.
Information checked 5 Nov 2026
Evidence: Mixed evidence
Studies: 2 for · 5 against
At least one controlled trial was positive, but other trials or large independent studies found no benefit.
33% slower decline in one 24-week early-stage trial
2.5 points less decline over 24 weeks, on the 48-point ALSFRS-R (Study 19 only)
MT-1186-A02 (daily vs on/off oral dosing)No benefit
Taking oral edaravone every day was no better than the approved on/off schedule over 48 weeks; the trial was stopped early for futility. It had no placebo group, so it does not test whether edaravone works.
ADORE (Ferrer's daily oral edaravone, FAB122)No benefit
A European placebo-controlled trial of a different daily oral edaravone found no slowing of decline over 48 weeks and no survival benefit.
German MND network real-world study (Witzel et al.)No benefit
At 12 German ALS centres, people on IV edaravone for about a year declined at the same rate as matched patients on standard care, with no difference in survival or time to ventilation, even in those who matched Study 19.
US insurance claims survival analysis (Brooks et al.)Met its main goal
A company-funded look back at US insurance records linked IV edaravone to about 6 months longer median survival. This kind of study cannot rule out that healthier people were more likely to get the drug.
MCI186-18 (more advanced ALS)No benefit
A small exploratory trial in people with more advanced ALS showed no difference from placebo after 24 weeks.
MCI186-19 (pivotal trial, early-stage ALS)Met its main goal
Met its main goal in carefully selected early-stage patients in Japan: 2.49 points less ALSFRS-R decline than placebo over 24 weeks. No difference in survival, breathing or strength was shown.
MCI186-16 (first Phase 3)No benefit
Missed its main goal: after 24 weeks, the ALSFRS-R score fell 5.70 points on edaravone and 6.35 on placebo, a difference that could be chance. A later look for patients who seemed to respond shaped the next trial.
Regulators' decisions for ALS
Regulators have reached different conclusions about this drug. Approval in one country is not proof that it works; it reflects that regulator's standards and the evidence it was shown.
- Japan PMDAApproved · 26 Jun 2015Approved in Japan to slow functional decline in ALS.
- USA FDAApproved · 5 May 2017IV form approved; oral Radicava ORS added on May 12, 2022.
- Canada Health CanadaApproved · 3 Oct 2018Approved after priority review, for ALS in general.
- EU EMAWithdrawn · 24 May 2019Company withdrew its application after the EMA's committee provisionally found effectiveness not proven and benefits not outweighing risks.
At a glance
CompanyShionogi (developed by Tanabe Pharma)Explanation and sources
Edaravone was discovered and developed by Tanabe Pharma (formerly Mitsubishi Tanabe Pharma) in Japan. In December 2025 Shionogi agreed to buy the global Radicava business for USD 2.5 billion, and the transfer of rights in major countries was completed on April 1-2, 2026, with more countries following. Both companies said supply and patient support services would not change.
Sources
- Shionogi Expands Rare Disease Presence with Planned Acquisition of Global Rights to RADICAVA ORS and IV RADICAVAShionogi · 22 Dec 2025 · Company press release
- Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone)Shionogi · 2 Apr 2026 · Company press release
- Tanabe Pharma America Announces Finalization of RADICAVA (edaravone) Transfer to ShionogiTanabe Pharma America · 1 Apr 2026 · Company press release
How it worksMops up harmful oxygen molecules (free radicals) that damage nervesFree radical scavenger (antioxidant)Explanation and sources
Oxidative stress, damage caused by unstable oxygen molecules called free radicals, is thought to contribute to motor neuron death in ALS. Edaravone neutralises free radicals. Exactly how this translates into slower loss of function in people with ALS is not fully understood.
Sources
- Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trialThe Lancet Neurology · 15 May 2017 · Peer-reviewed paper
- Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone)Shionogi · 2 Apr 2026 · Company press release
StageApprovedApproved in USA, Japan, Canada and others; EU application withdrawnExplanation and sources
Edaravone was approved for ALS in Japan on June 26, 2015, then in South Korea, the USA (IV on May 5, 2017; oral Radicava ORS on May 12, 2022), Canada (October 2018), Switzerland, Indonesia, Thailand, Malaysia, Australia and Brazil. In the EU, the company withdrew its application in May 2019 after the EMA's expert committee provisionally concluded it could not be approved because its effectiveness was not proven.
Sources
- Mitsubishi Tanabe Pharma receives approval for additional indication for ALS in Japan (Radicut)Mitsubishi Tanabe Pharma · 26 Jun 2015 · Company press release
- FDA approves drug to treat ALSUS FDA (via PR Newswire) · 5 May 2017 · Regulator
- FDA Approves Oral Form for the treatment of adults with ALSUS FDA · 12 May 2022 · Regulator
- Regulatory Decision Summary for RadicavaHealth Canada · 3 Oct 2018 · Regulator
- Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone)Shionogi · 2 Apr 2026 · Company press release
- Radicava - withdrawal of applicationEuropean Medicines Agency · 24 May 2019 · Regulator
Best reported effect33% slower decline in one 24-week early-stage trial2.5 points less decline over 24 weeks, on the 48-point ALSFRS-R (Study 19 only)Explanation and sources
In the trial behind the approval (Study 19, 137 people in Japan), the ALSFRS-R score fell 5.01 points on edaravone versus 7.50 on placebo over 24 weeks. That trial only enrolled people with early ALS, a group picked after the first Phase 3 trial (206 people) missed its goal. There was no benefit shown on survival, breathing or strength, and the EMA questioned the small size, short length and differences between the groups. A large independent German study of everyday use found no slowing of decline and no longer survival, and two later trials of daily oral edaravone found no extra benefit.
Sources
- Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trialThe Lancet Neurology · 15 May 2017 · Peer-reviewed paper
- Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patientsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration (PMC) · 1 Dec 2014 · Peer-reviewed paper
- Radicava - withdrawal of applicationEuropean Medicines Agency · 24 May 2019 · Regulator
- Safety and Effectiveness of Long-term Intravenous Administration of Edaravone for Treatment of Patients With Amyotrophic Lateral SclerosisJAMA Neurology · 10 Jan 2022 · Peer-reviewed paper
- Clinical Review Report: Edaravone (Radicava), ResultsCADTH (via NCBI Bookshelf) · Regulator
Who it's forAdults with ALS (pivotal trial enrolled only early-stage ALS)All ALS · Oral liquid or IV, on/off 28-day cyclesExplanation and sources
The US label covers ALS in general, but the evidence comes from people aged 20 to 75 with ALS for 2 years or less and lung function of 80% or more. The first 28-day cycle is 14 days on and 14 days off, then 10 of 14 days on and 14 off. Radicava ORS is taken in the morning after an overnight fast, by mouth or feeding tube, with no food for an hour afterwards.
Sources
- Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trialThe Lancet Neurology · 15 May 2017 · Peer-reviewed paper
- Tanabe Pharma America Announces Finalization of RADICAVA (edaravone) Transfer to ShionogiTanabe Pharma America · 1 Apr 2026 · Company press release
- FDA Approves Oral Form for the treatment of adults with ALSUS FDA · 12 May 2022 · Regulator
How to get itPrescription in USA, Japan, Canada and others; not approved in EUExplanation and sources
Where approved, edaravone is a prescription medicine; ask your neurologist. In the USA, the brand-name IV form was discontinued for business reasons from as early as April 2025, but the oral Radicava ORS remains, and generic IV edaravone is sold by other companies. It is not approved in the European Union, so access there depends on national rules.
Sources
- Mitsubishi Tanabe Pharma America to Discontinue Intravenous (IV) RADICAVA (edaravone)Mitsubishi Tanabe Pharma America · 10 Oct 2024 · Company press release
- Radicava - withdrawal of applicationEuropean Medicines Agency · 24 May 2019 · Regulator
- Shionogi Recognizes the Four-Year Anniversary of RADICAVA ORS (edaravone)Shionogi Inc. · 30 Jul 2026 · Company press release
Timeline
13 events, newest first. Company updates are marked; independent news and regulator decisions are shown too.
2026
Shionogi to present real-world edaravone data at NEALS 2026
Three posters on real-world use of Radicava ORS and remote breathing monitoring were planned. Real-world analyses are not randomised and cannot prove benefit on their own.
Shionogi marks four years of Radicava ORS
Shionogi said more than 17,300 US patients have been treated with the oral form since June 2022.
Shionogi completes acquisition of Radicava
Shionogi said it now holds rights in major countries, with other countries to follow, and that more than 100 staff joined from Tanabe Pharma America.
Tanabe Pharma America completes Radicava transfer
The US business moved to Shionogi. Tanabe said supply, patient support and contacts would continue unchanged.
2025
Shionogi agrees to buy global Radicava rights
Shionogi agreed to pay USD 2.5 billion for the worldwide Radicava business from Tanabe Pharma, and said it may also pay royalties on future sales.
2024
Brand-name IV Radicava to be discontinued in the USA
The company said it would stop the IV form as early as April 1, 2025 for business reasons, not safety or effectiveness. Generic IV edaravone and Radicava ORS remain available.
2022
FDA approves oral Radicava ORS
An oral liquid form of edaravone, taken at home by mouth or feeding tube, was approved with the same on/off dosing schedule as the IV form.
Mitsubishi Tanabe Pharma America announces Radicava ORS approval
The company said Radicava ORS offers the same drug and efficacy as the IV formulation, without infusions.
2019
Mitsubishi Tanabe explains EU withdrawal
The company said the EMA wanted an extra placebo-controlled survival study of at least 12 months, which it considered unwarranted.
Application in the EU withdrawn
The company withdrew its EU application. The EMA's committee was of the provisional opinion that Radicava could not be approved, citing a small study, short follow-up and no proven benefit on survival, breathing or strength.
2017
Pivotal Study 19 published in The Lancet Neurology
The full results showed benefit in a narrowly defined early-stage group. The authors wrote there was no indication edaravone works in people who do not meet the trial's strict criteria.
FDA approves Radicava (IV edaravone) for ALS
The FDA approved intravenous edaravone, the first new ALS treatment in the USA since riluzole in 1995, based on a six-month Japanese trial in 137 people.
MT Pharma America announces Radicava approval
The company said Radicava slowed the decline of physical function by 33% (2.49 ALSFRS-R points) compared with placebo over six months.
All sources for this page
- Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trialThe Lancet Neurology · 15 May 2017 · Peer-reviewed paper
- FDA approves drug to treat ALSUS FDA (via PR Newswire) · 5 May 2017 · Regulator
- MT Pharma America Announces FDA Approval of RADICAVA (Edaravone)Mitsubishi Tanabe Pharma America · 5 May 2017 · Company press release
- Radicava - withdrawal of applicationEuropean Medicines Agency · 24 May 2019 · Regulator
- Withdrawal of Marketing Authorization Application of edaravone for ALS in the European UnionMitsubishi Tanabe Pharma · 30 May 2019 · Company press release
- FDA Approves Oral Form for the treatment of adults with ALSUS FDA · 12 May 2022 · Regulator
- Mitsubishi Tanabe Pharma America Announces FDA Approval of RADICAVA ORSMitsubishi Tanabe Pharma America · 12 May 2022 · Company press release
- Extension Study MT-1186-A04 of once-daily versus on/off oral edaravone (abstract)American Academy of Neurology · Conference presentation
- Mitsubishi Tanabe Pharma America to Discontinue Intravenous (IV) RADICAVA (edaravone)Mitsubishi Tanabe Pharma America · 10 Oct 2024 · Company press release
- Shionogi Expands Rare Disease Presence with Planned Acquisition of Global Rights to RADICAVA ORS and IV RADICAVAShionogi · 22 Dec 2025 · Company press release
- Tanabe Pharma America Announces Finalization of RADICAVA (edaravone) Transfer to ShionogiTanabe Pharma America · 1 Apr 2026 · Company press release
- Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone)Shionogi · 2 Apr 2026 · Company press release
- Shionogi Recognizes the Four-Year Anniversary of RADICAVA ORS (edaravone)Shionogi Inc. · 30 Jul 2026 · Company press release
- Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patientsAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration (PMC) · 1 Dec 2014 · Peer-reviewed paper
- Radicava (edaravone) NDA 209176 statistical reviewUS FDA · Regulator
- Clinical Review Report: Edaravone (Radicava), ResultsCADTH (via NCBI Bookshelf) · Regulator
- Safety and Effectiveness of Long-term Intravenous Administration of Edaravone for Treatment of Patients With Amyotrophic Lateral SclerosisJAMA Neurology · 10 Jan 2022 · Peer-reviewed paper
- Intravenous edaravone treatment in ALS and survival: An exploratory, retrospective, administrative claims analysiseClinicalMedicine (The Lancet) · Peer-reviewed paper
- Mitsubishi Tanabe Pharma America Presents Final Results from the Global Phase 3b MT-1186-A02 Post-Marketing Study of RADICAVA ORSMitsubishi Tanabe Pharma America · 17 Jun 2024 · Company press release
- Efficacy and Safety of Once Daily Dosing vs. Approved On/Off Dosing of Edaravone Oral Suspension Up to 48 Weeks in Patients With ALS (Study MT-1186-A02)Muscle & Nerve · Peer-reviewed paper
- Ferrer Announces Primary Results of Phase III ADORE Clinical Trial in ALSFerrer · 10 Jan 2024 · Company press release
- Mitsubishi Tanabe Pharma receives approval for additional indication for ALS in Japan (Radicut)Mitsubishi Tanabe Pharma · 26 Jun 2015 · Company press release
- Regulatory Decision Summary for RadicavaHealth Canada · 3 Oct 2018 · Regulator
- Shionogi to Present New Real-World Data Advancing the Understanding of ALS at the 2026 Annual NEALS MeetingShionogi Inc. · 26 Oct 2026 · Company press release