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Edaravone

Alternative Names: edaravone, mci-186, radicava, radicava ors, fab-122, FAB122, TTYP01, TTYP-01
Latest Update: 2024-09-20
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Edaravone

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

Recent News Events

Date

Type

Title

09/17/2024

News Article

Mitsubishi Tanabe Pharma America to Showcase RADICAVA ORS® (edaravone) Presentations at 2024 Neuromuscular Study Group Annual Meeting

09/12/2024

News Article

Mitsubishi Tanabe Pharma America to Present Latest Neurodegenerative Research at the 2024 American Neurological Association 149th Annual Meeting

09/05/2024

News Article

Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration

07/23/2024

News Article

Amyotrophic Lateral Sclerosis Treatment Market size is set to grow by USD 663.7 million from 2024-2028, Increase in incidence and prevalence of amyotrophic lateral sclerosis to boost the market growth, Technavio

10/10/2024

News Article

Mitsubishi Tanabe Pharma America to Showcase New RADICAVA ORS® (edaravone) Real-World Data at 2024 Academy of Managed Care Pharmacy Nexus Meeting

10/10/2024

News Article

Mitsubishi Tanabe Pharma America to Showcase New RADICAVA ORS® (edaravone) Real-World Data at 2024 Academy of Managed Care Pharmacy Nexus Meeting

09/17/2024

News Article

Mitsubishi Tanabe Pharma America to Showcase RADICAVA ORS® (edaravone) Presentations at 2024 Neuromuscular Study Group Annual Meeting

09/12/2024

News Article

Mitsubishi Tanabe Pharma America to Present Latest Neurodegenerative Research at the 2024 American Neurological Association 149th Annual Meeting

09/05/2024

News Article

Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration