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: None
Known Adverse Events: None
Company: Mitsubishi Tanabe
Company Location: Asia Pacific
Company CEO:
Additional 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: 22
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Syneos Health presented P3 Amyotrophic Lateral Sclerosis results on 2024-04-14 for Edaravone
Highest Development Phases
Phase 3: Amyotrophic Lateral Sclerosis|Ischemic Stroke
Phase 2: Alzheimer Disease|Autism Spectrum Disorder|Cerebral Hemorrhage|Stroke
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04984577 |
NJYK-CPEDRV-II | P2 |
Suspended |
Ischemic Stroke |
2026-12-31 |
77% |
2024-02-21 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT06315231 |
SIM0308-02-Y-2-201 | P2 |
Recruiting |
Stroke |
2026-12-30 |
2025-09-04 |
Patient Enrollment|Primary Endpoints|Treatments |
|
NCT06757504 |
TTYP01-â ¡-ASD | P2 |
Recruiting |
Autism Spectrum Disorder |
2026-02-06 |
12% |
2025-01-09 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT07252440 |
TTYP01-â ¡-AD | P2 |
Recruiting |
Alzheimer Disease |
2028-10-23 |
2025-11-27 |
Primary Endpoints|Treatments |
|
NCT05178810 |
ADORE | P3 |
Completed |
Amyotrophic Lateral Sclerosis |
2023-10-26 |
10% |
2024-09-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
CTR20244760 |
CTR20244760 | P2 |
Recruiting |
Autism Spectrum Disorder |
None |
2025-06-22 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
CTR20240862 |
CTR20240862 | P2 |
Recruiting |
Ischemic Stroke |
None |
2025-09-14 |
Patient Enrollment|Treatments |
|
2021-003900-42 |
2021-003900-42 | P3 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2025-07-15 |
|||
jRCT2071210117 |
jRCT2071210117 | P3 |
Recruiting |
Amyotrophic Lateral Sclerosis |
2024-06-30 |
|||
NCT06648304 |
TTYP01-III-AIS | P3 |
Completed |
Ischemic Stroke |
2024-06-17 |
11% |
2024-10-19 |
Primary Endpoints|Treatments |
2019-004256-11 |
2019-004256-11 | P3 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2024-05-11 |
18% |
2022-03-13 |
Treatments |
jRCT2031200301 |
jRCT2031200301 | P3 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2023-11-30 |
18% |
||
2020-003376-40 |
2020-003376-40 | P3 |
Completed |
Amyotrophic Lateral Sclerosis |
2023-10-26 |
2025-05-17 |
Treatments |
|
jRCT2041200084 |
jRCT2041200084 | P3 |
Active, not recruiting |
Amyotrophic Lateral Sclerosis |
2023-09-30 |
19% |
||
2020-000376-38 |
2020-000376-38 | P3 |
Completed |
Amyotrophic Lateral Sclerosis |
2023-08-09 |
19% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
NCT04577404 |
MT-1186-A03 | P3 |
Completed |
Amyotrophic Lateral Sclerosis |
2023-08-09 |
19% |
2024-08-29 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06107205 |
TTYP01-02-2022 | P1 |
Completed |
Healthy Volunteers |
2023-12-14 |
69% |
2024-03-26 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT05568615 |
MT-1186-A-301 | P3 |
Completed |
Amyotrophic Lateral Sclerosis |
2023-06-27 |
19% |
2023-10-28 |
Primary Endpoints |
CTR20160802 |
CTR20160802 | P1 |
Recruiting |
Ischemic Stroke |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
NCT05323812 |
ASURE | P2 |
Completed |
Alzheimer Disease |
2024-12-30 |
6% |
2025-04-16 |
Primary Endpoints |
CTR20232311 |
CTR20232311 | P2 |
Completed |
Ischemic Stroke |
2024-03-19 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20231571 |
CTR20231571 | P2 |
Recruiting |
Cerebral Hemorrhage |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |