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Edaravone

Generic Name
Edaravone
Brand Names
Radicava
Drug Type
Small Molecule
Chemical Formula
C10H10N2O
CAS Number
89-25-8
Unique Ingredient Identifier
S798V6YJRP
Background

Edaravone is a free radical scavenger and neuroprotective agent with antioxidant properties. It has three tautomers. Edaravone works to scavenge reactive oxygen species, which have been implicated in neurological disorders, such as amyotrophic lateral sclerosis (ALS) and cerebral ischemia.

The intravenous formulation of edaravone was first approved in Japan in 2001 for the treatment of acute ischemic stroke. It was later approved for the treatment of amyotrophic lateral sclerosis (ALS) in Japan and South Korea in 2015, followed by the FDA approval in May 2017 and Health Canada approval in October 2018. The oral suspension formulation of edaravone was approved by the FDA in May 2022 and by Health Canada in November 2022.

Edaravone was initially granted orphan designation by the European Medicines Agency on June 19, 2015 and was under regulatory review in Europe. However, the drug manufacturer, Mitsubishi Tanabe Pharma, withdrew the Marketing Authorization Application (MAA) for edaravone from the European market on May 24, 2019, in response to the request made by the Committee for Medicinal Products for Human Use (CHMP) for a long-term study demonstrating the long-term efficacy and safety of edaravone. Edaravone was also investigated in other disorders, such as Alzheimer's disease, neuropathic pain, and ischemia-induced nerve injury.

Indication

Edaravone is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in the US and Canada. It is also indicated to treat acute ischemic stroke in Japan.

Associated Conditions
Amyotrophic Lateral Sclerosis (ALS)
Clinical Trials
Related News

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Edaravone Shows Promise in Targeting TDP-43 Mislocalization in ALS, New Preclinical Research Reveals

• Mitsubishi Tanabe Pharma America published new preclinical research demonstrating edaravone's ability to mitigate TDP-43 mislocalization, a hallmark feature in over 97% of sporadic ALS cases. • The study, using iPSC-derived motor neurons from an ALS patient, showed edaravone significantly reduced abnormal cytoplasmic accumulation of TDP-43 and restored its nuclear localization through the SIRT1-XBP1 pathway. • These findings suggest edaravone may offer broader therapeutic benefits in ALS beyond its known antioxidant properties, potentially addressing both oxidative stress and protein mislocalization mechanisms.

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Real-World Data Analysis Shows Edaravone Associated with Longer Milestone-Free Time in ALS

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• Simcere's sublingual edaravone/dexborneol, Sanbexin, has received approval in China for treating acute ischemic stroke, marking a significant advancement in stroke therapy. • Clinical data indicates that Sanbexin sublingual improved functional outcomes in acute ischemic stroke patients by approximately 10% at day 90. • The recent approval is setting the stage for an international Phase III trial to further evaluate the efficacy and safety of Sanbexin in a broader patient population. • This sublingual formulation offers a potentially faster and more convenient administration route compared to traditional intravenous edaravone, addressing critical needs in acute stroke management.

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• Mitsubishi Tanabe Pharma America (MTPA) presented real-world data on RADICAVA ORS® (edaravone) at the 2024 NASP Annual Meeting, focusing on ALS treatment. • The presentations included patient demographics, treatment duration, progression milestones, and healthcare resource utilization among RADICAVA ORS®-treated individuals. • Analyses of clinical characteristics from Optum's Clinformatics® Data Mart (CDM) provided insights into the real-world impact of RADICAVA ORS® in ALS treatment. • These findings underscore MTPA's commitment to advancing medical knowledge and improving patient care in amyotrophic lateral sclerosis.

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