Product Description
Edaravone, a member of the substituted 2-pyrazolin-5-one class, has the chemical name 3-methyl-1-phenyl-2-pyrazolin-5-one. It is a white crystalline powder with a melting point of 129.7° C and is freely soluble in acetic acid, methanol, or ethanol, as well as slightly soluble in water or diethyl ether. Although the exact mechanism of action of edaravone in the treatment of ALS is unknown, its therapeutic effect may be due to its known antioxidant properties; oxidative stress is a part of the process that kills neurons in patients with ALS (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5737249/)
Mechanisms of Action: Free Radical Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous,Oral
FDA Designation: Orphan Drug - *
Approval Status: Approved
Approved Countries: Argentina | Australia | Brazil | Canada | China | Greece | India | Indonesia | Israel | Japan | Korea | Malaysia | Philippines | Switzerland | Ukraine | United States
Approved Indications: Amyotrophic Lateral Sclerosis
Known Adverse Events: Headache
Company: Mitsubishi Tanabe
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, Canada, China, Croatia, France, Germany, Ireland, Italy, Japan, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Amyotrophic Lateral Sclerosis|Ischemic Stroke
Phase 2: Alzheimer Disease|Cerebral Hemorrhage
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NJYK-CPEDRV-II | P2 |
Suspended |
Ischemic Stroke |
2026-12-31 |
32% |
| ADOREXT | P3 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2025-11-24 |
|
| 2021-003900-42 | P3 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2025-07-15 |
|
| EARLYS | P3 |
Not yet recruiting |
Ischemic Stroke |
2024-12-31 |