Tanabe Pharma Corporation announced that its subsidiary, Tanabe Pharma Korea Co., Ltd., has gotten approval from Korea's Ministry of Food and Drug Safety for Radicut Suspension to treat Amyotrophic Lateral Sclerosis (ALS). The approval was granted on December 10, 2025.
Radicut Suspension is an oral version of edaravone, which was previously only accessible as an intravenous injection in Korea. The new oral suspension focuses to make it simple for ALS patients to manage their treatment, reducing the discomfort from injections and frequent hospital visits. This development is part of Tanabe Pharma's aim to offer better treatment alternatives for ALS patients, catering to the unmet demands in rare diseases.
This oral suspension was introduced by Tanabe Pharma America, Inc., and was approved by the U.S. FDA in May 2022. It also received orphan-drug approval from the FDA in April 2024 for its major contribution to ALS care. The product is already approved in several other countries, including the U.S., Canada, Japan, and Switzerland, and is being made available to patients there.
Edaravone, the active ingredient in Radicut, was originally developed by Tanabe Pharma as a free radical scavenger. It was first approved in Japan in 2001 for curing acute cerebral infarction alongside later received approval for ALS in 2015. Today, Radicut is available in multiple countries, including Korea, the U.S., Canada, Japan, Switzerland, and others.