Last reviewed · How we verify
Radicava (EDARAVONE)
Radicava works by scavenging free radicals and reducing oxidative stress in the body.
At a glance
| Generic name | EDARAVONE |
|---|---|
| Sponsor | Kk Bcj-94 |
| Drug class | edaravone |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
The mechanism by which RADICAVA exerts its therapeutic effect in patients with ALS is unknown.
Approved indications
- Amyotrophic lateral sclerosis
- Ischemic stroke
Common side effects
- Contusion
- Gait disturbance
- Headache
- Dermatitis
- Eczema
- Respiratory failure, respiratory disorder, hypoxia
- Glycosuria
- Tinea infection
Key clinical trials
- A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects (PHASE1)
- Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids (PHASE2)
- Edaravone and Dexborneol Sublingual Tablet for Treating Chemotherapy- Induced Cognitive Impairment Study (PHASE4)
- Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment (PHASE1)
- PK Study in Subjects With Severe Hepatic Impairment (PHASE1)
- Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke (PHASE2)
- Dose Finding Study of MCI-186 in Acute Ischemic Stroke (PHASE2)
- Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |