U.S. and Canada transaction supports continued access to RADICAVA® for people living with ALS while enabling Tanabe Pharma America to focus on future growth and innovation
JERSEY CITY, N.J., Dec. 22, 2025 /PRNewswire/ — Tanabe Pharma America, Inc. (TPA), a wholly owned subsidiary of Tanabe Pharma Corporation (TP), has recently made significant headlines with its announcement regarding RADICAVA®. The Board of Directors for both Tanabe Pharma and Shionogi & Co., Ltd. ratified the transfer of global rights for RADICAVA®, which includes essential rights in Japan, the United States, and Canada. This agreement, executed on December 22, 2025, marks a key milestone for both companies, enabling Tanabe Pharma America to sharpen its focus on future innovations while ensuring continued access to this vital therapy for individuals living with amyotrophic lateral sclerosis (ALS).
RADICAVA® has emerged as a leading treatment option for ALS, a progressive neurodegenerative disorder that affects motor neurons, ultimately impairing voluntary muscle action. The transition of RADICAVA®’s business to Shionogi is poised not only to enhance the drug’s growth trajectory but also aligns RADICAVA® with a company that has dedicated resources and a strategic focus on rare diseases, particularly ALS. Yasutoshi Kawakami, President of Tanabe Pharma America, noted the pride the company feels in bringing this critical therapy to U.S. and Canadian patients and expressed optimism about its continued availability under Shionogi’s stewardship.
Transaction Specifics
The official agreement to transition RADICAVA® business was executed on December 22, 2025. Until the closing of this transaction, operations will continue seamlessly, with Tanabe Pharma America maintaining responsibility for RADICAVA® in North America. The transfer is expected to culminate in the second quarter of 2026, subject to standard regulatory approvals. Importantly, there are no anticipated changes in the current supply chain, ensuring that RADICAVA® remains accessible to patients during this transition period.
A Commitment to Patient Care and Innovation
This strategic move allows the Tanabe Pharma group to consolidate its resources and reinforce its financial foundation. By transitioning RADICAVA® to Shionogi, Tanabe Pharma America can dedicate its focus to developing new therapies that target unmet medical needs. The company’s mission, “Creating hope for all facing illness,” remains at the forefront as it continues to pursue internal research and forge strategic partnerships aimed at delivering innovative therapies across North America.
Understanding RADICAVA ORS®
RADICAVA ORS® (edaravone) received FDA approval on May 12, 2022, specifically for the treatment of ALS. This formulation provides the significant advantage of an oral suspension, facilitating easier administration compared to traditional intravenous (IV) options. Administered daily for 14 consecutive days, followed by a two-week drug-free period, RADICAVA ORS® offers a new lifeline to patients. This innovation is particularly vital considering the challenges associated with IV administration, making RADICAVA ORS® a welcomed alternative for many individuals with ALS.
The process of discovering and developing edaravone for ALS was initiated by Tanabe Pharma in 2001. After an extensive clinical development period, the drug received marketing approval as RADICUT® in Japan and South Korea in 2015. The global rollout continued, culminating in approvals across various countries, including Canada, Switzerland, and Australia, highlighting the dedication to meeting the needs of ALS patients worldwide.
Safety and Efficacy Considerations
While RADICAVA ORS® offers significant benefits, it is also essential for patients and healthcare providers to be aware of potential safety concerns. The drug is contraindicated in individuals with a known hypersensitivity to edaravone or its inactive ingredients. Monitoring for hypersensitivity reactions is critical, and if such reactions occur, immediate discontinuation and treatment are advised.
Furthermore, the presence of sodium bisulfite in RADICAVA ORS® might trigger allergic reactions in susceptible individuals. Hence, awareness and precaution are crucial when administering this therapy. Adverse reactions reported amongst patients treated with RADICAVA® have included contusions and gait disturbances, emphasizing the need for ongoing patient monitoring post-administration.
The safety profile established through clinical trials underscores the importance of carefully weighed risks and benefits when considering RADICAVA ORS® as a treatment option for ALS.
The Road Ahead for Tanabe Pharma
Tanabe Pharma America, while transitioning RADICAVA®, is also poised to drive its pipeline of innovative therapies forward. As it strengthens its financial base, the company’s strategic direction will enable the advancement of new treatments that tackle pressing medical needs in various therapeutic areas. Their commitment to innovation and patient care remains unwavering, with an emphasis on creating solutions that improve the quality of life for patients facing challenging health conditions.
About Tanabe Pharma Corporation
Founded in 1678, Tanabe Pharma Corporation has a rich history as one of the oldest pharmaceutical companies globally. With its headquarters in Osaka, Japan, the company emphasizes “precision medicine,” aiming to deliver highly effective therapies across diverse disease areas. Its focus extends to developing “around the pill solutions” that incorporate patient insights into therapeutic approaches, addressing not only the treatment of diseases but also their prevention and management.
As the landscape of ALS treatment continues to evolve, the ongoing developments within Tanabe Pharma and the transition of RADICAVA® signify pivotal steps toward enhancing patient outcomes and sustaining the vital support system needed by the ALS community.