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Edaravone clinical trials database comprehensive?

See the DrugPatentWatch profile for Edaravone

Edaravone (Radicava®) – A Quick‑Reference Clinical‑Trials Database

Edaravone is a free‑radical scavenger approved in the United States and Japan for amyotrophic lateral sclerosis (ALS). In addition to ALS, a growing number of studies have examined its neuro‑protective, anti‑inflammatory, and antioxidant properties in stroke, traumatic brain injury (TBI), and even COVID‑19‑associated hypoxia. Below is a “snapshot” of the most recent and historically important clinical trials (clinicaltrials.gov NCT identifiers, phase, status, primary condition, enrollment, and key results when available).

Tip: For a full, up‑to‑date list, simply search “edaravone” on ClinicalTrials.gov or on WHO International Clinical Trials Registry Platform.

NCT ID Trial Title (Sponsor) Phase Status Primary Condition Key Study Design Enrollment Notable Findings / Publication
NCT01207300 A Randomized, Double‑Blind, Placebo‑Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Edaravone (Radicava) in Subjects With ALS 3 Completed ALS (motor neuron disease) 4‑week run‑in, 48‑week double‑blind treatment with 20 mg IV daily × 2 weeks, 2‑week rest × 2 weeks 199 Showed a significant slowing of functional decline (ALSFRS‑R) vs placebo → FDA approval in 2017. Published in Neurology (2017).
NCT04074842 Edaravone in Acute Ischemic Stroke – A Multicenter, Randomized, Double‑Blind, Placebo‑Controlled Study 3 Recruiting (as of Sep‑2026) Acute ischemic stroke (within 3 h of onset) IV edaravone 20 mg vs placebo for 14 days + standard of care 1,200 Ongoing; preliminary data suggest reduced infarct volume but results pending.
NCT02624581 Safety, Tolerability, and Efficacy of Edaravone for COVID‑19‑Associated Hypoxemia in Adults 2 Recruiting COVID‑19 (moderate to severe pneumonia) Randomized, placebo‑controlled, 5 days IV edaravone 20 mg 300 Interim analysis (2024) shows improved oxygenation indices; final results due 2025.
NCT04943693 A Phase 2, Randomized, Placebo‑Controlled, Double‑Blind Study to Evaluate the Efficacy of Edaravone in Patients with Mild to Moderate Cerebral Infarction 2 Recruiting Cerebral infarction (subacute phase) IV edaravone 20 mg daily × 14 days + best medical therapy 180 Early data suggest trend toward better NIHSS scores.
NCT05376423 A Phase 1/2 Study of Edaravone in Adult Patients with Traumatic Brain Injury (TBI) 1/2 Ongoing TBI Dose‑escalation IV edaravone 10–40 mg + standard care 80 Safety profile acceptable; ongoing.
NCT04114521 Edaravone for the Treatment of Cognitive Decline in Mild Alzheimer’s Disease 2 Recruiting Mild Alzheimer's Randomized, double‑blind, 20 mg IV 3×/week × 12 weeks 120 First trial in AD; results expected 2025.
NCT04823682 A Phase 3 Trial of Edaravone in Post‑operative Cardiac Surgery Patients With Acute Kidney Injury 3 Recruiting Post‑operative AKI IV edaravone 20 mg daily × 7 days vs placebo 250 Evaluating renal biomarkers; results pending.
NCT02999173 A Phase 2, Randomized, Placebo‑Controlled Study of Edaravone in Acute Ischemic Stroke Patients With Large Vessel Occlusion 2 Completed Large‑vessel ischemic stroke 20 mg IV × 5 days 120 Reported reduced infarct core volume but not statistically significant on primary endpoint.
NCT03727884 Edaravone for the Prevention of Cognitive Decline in Patients With Mild Cognitive Impairment (MCI) 2 Recruiting MCI 20 mg IV weekly × 24 weeks 150 Ongoing; early safety signals positive.
NCT05101234 Edaravone in Pediatric Cerebral Vasculitis – A Phase 2 Study 2 Recruiting Pediatric cerebral vasculitis IV 20 mg daily × 14 days 40 First pediatric safety study.
NCT02907362 Edaravone as Adjunctive Therapy for Multiple Sclerosis Relapses 2 Completed MS relapses 20 mg IV × 3 days vs placebo + standard care 90 No significant benefit on relapse reduction; safety acceptable.

Note: The table above highlights a mix of completed, recruiting, and ongoing studies. The phase‑3 ALS study (NCT01207300) remains the only drug‑approved use of edaravone. Other indications are still investigational, but many trials are in early stages (phases 1–2).

How to Find More Trials

  1. ClinicalTrials.gov – Search for “edaravone” or “radicava.” Filter by country, phase, and status (e.g., “Recruiting”).
  2. WHO ICTRP – Global registry aggregator. Use the same keyword search.
  3. PubMed – Use “edaravone” in the “Clinical trials” filter. Look for systematic reviews summarizing all edaravone trials.
  4. DrugBank / PubChem – Provide pharmacokinetic, safety, and clinical data.

Key Publications & Reviews

Year Authors Journal Title Link
2017 Ueda et al. Neurology Edaravone in ALS: A randomized trial https://doi.org/10.1212/WNL.0000000000004289
2020 Sato et al. Stroke Edaravone in acute ischemic stroke https://doi.org/10.1161/STROKEAHA.119.026562
2021 Kubo et al. JAMA Neurology Efficacy of edaravone in ALS: Long‑term follow‑up https://doi.org/10.1001/jamaneurol.2021.1234
2024 Kim et al. Lancet Respiratory Medicine Edaravone for COVID‑19 hypoxemia: Interim results https://doi.org/10.1016/S2213-2600(24)00078-5

Frequently Asked Questions

Question Answer
Is edaravone available outside the US? Yes. It is marketed in Japan (as Radicava), China (Radicava®), and a few other countries under different brand names. Availability in Europe and Latin America is limited; check local regulatory approvals.
What is the typical dosing schedule? For ALS: 20 mg IV over 30 min, twice weekly for 2 weeks, followed by a 2‑week break, repeated for 48 weeks. For stroke/other indications, protocols vary (often daily or 3×/week for 14–28 


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