Radicut Suspension Approved in Korea for the Treatment of ALS

Press Release 1/2 December 12, 2025 Radicut Suspension Approved in Korea for the Treatment of ALS Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director, CEO: Akihisa Harada; hereinafter, “Tanabe Pharma”) announced today that Tanabe Pharma Korea Co., Ltd, which is a consolidated subsidiary of Tanabe Pharma obtained the approval from the ministry of Food and Drug Safety in Korea to Radicut Suspension for the indication of amyotrophic lateral sclerosis (hereinafter, "ALS") on December 10, 2025. Radicut Suspension is an oral suspension formulation that contains the same active ingredient as edaravone for intravenous infusion (Korean product name: RADICUT® Injection 30mg). Formerly, Radicut could only be administered via intravenous infusion in Korea. Tanabe Pharma Group has developed the oral suspension formulation as a new treatment option for ALS patients to reduce burdens on people living with ALS such as injection pain and outpatient visits. Tanabe Pharma Group is working to provide patients with new drugs that address unmet medical needs, including rare diseases, through our own development and through partnerships with other companies. ■ About Edaravone Oral Suspension Edaravone oral suspension was developed by Tanabe Pharma America, Inc., a subsidiary of Tanabe Pharma, for the indication of amyotrophic lateral sclerosis (ALS), and was approved by the U.S. Food and Drug Administration (FDA) in May 2022. In April 2024, Edaravone oral Contact: Tanabe Pharma Corporation CEO Office PR Group +81-6-6205-5119 2/2 suspension received orphan-drug exclusive approval from the U.S. FDA as a product with major contribution to patient care for people living with ALS. In addition to the U.S., approval has also been obtained in Canada, Japan, and Switzerland, and the product is being delivered to patients in these countries. ■ About Edaravone Edaravone is a free radical scavenger discovered by Tanabe Pharma. It was approved by the Ministry of Health, Labour and Welfare in April 2001 for the treatment of patients with acute cerebral infarction and is marketed in Japan under the product name of Radicut®. This product obtained approval for an additional indication of ALS in Japan in 2015 and has since been launched in Korea, the U.S., Canada, Switzerland, Indonesia, Thailand, Malaysia, Australia and Brazil.

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