Tanabe Pharma America Announces Transfer of RADICAVA® Business to Shionogi
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), the wholly owned subsidiary of Tanabe Pharma Corporation (TP), today announced that TP's Board of Directors, together with the Board of Directors of Shionogi & Co., Ltd., has approved the transfer of global rights to RADICAVA®—including rights in Japan, the United States, and Canada—to Shionogi, under an agreement executed on December 22, 2025. As part of the transaction, Tanabe Pharma America, Inc. will establish a new U.S. company to manage the RADICAVA® business, which Shionogi Inc. will acquire as a wholly owned subsidiary.
RADICAVA® is a leading therapy for amyotrophic lateral sclerosis (ALS), and this transaction is intended to support the long-term growth and sustainability of the brand by aligning it with a company that has a strong strategic focus on rare diseases and long-term commitment to the ALS community.
"As the company that helped bring RADICAVA® to patients in the United States and Canada, we are incredibly proud of the impact this therapy has had on the ALS community," said Yasutoshi Kawakami, President, Tanabe Pharma America. "By transitioning the RADICAVA® business to Shionogi, we believe the product is well positioned to continue reaching patients and caregivers who rely on it, while Tanabe Pharma America sharpens its focus on advancing future therapies."
Key Transaction Details
Until the transaction closes, operations will continue as usual, and Tanabe Pharma America will remain responsible for the RADICAVA® business in North America.
- The agreement to transfer the RADICAVA® business was executed on December 22, 2025.
- In North America, the RADICAVA® business will transfer to Shionogi Inc. and is expected to become a wholly owned subsidiary of Shionogi Inc.
- The transaction is subject to customary regulatory approvals and is expected to close in the second quarter of 2026.
There are no anticipated changes to the current supply chain or product availability for RADICAVA® as a result of this transaction.
A Continued Commitment to Patients and Innovation
This transaction allows Tanabe Pharma America and the broader Tanabe Pharma Group to strengthen their financial foundation and focus resources on advancing promising pipeline assets and core therapeutic areas, including treatments addressing significant unmet medical needs.
Under its mission, "Creating hope for all facing illness," Tanabe Pharma America will continue to pursue innovation through internal research and strategic partnerships, with a continued commitment to delivering meaningful therapies to patients in North America.
Advisors
Centerview Partners LLC served as lead financial advisor, and Ropes & Gray LLP served as legal counsel to Tanabe Pharma Corporation. Goldman Sachs also provided financial advice to Tanabe Pharma. Cleary Gottlieb Steen & Hamilton LLP served as legal advisor to Shionogi. Bank of America served as financial advisor to Bain Capital.
About RADICAVA ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg (5mL) dose of RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1
Edaravone was discovered and developed for ALS by Tanabe Pharma and commercialized in the U.S. by Tanabe Pharma America, Inc. The Tanabe Pharma group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021), Australia (February 2023) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA® (edaravone), have been used to treat over 19,000 people with ALS, with over 2.5-million days of therapy, and have been prescribed by over 2,600 HCPs.2-4
INDICATION
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
Sulfite Allergic Reactions
RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Pregnancy
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information, also available at www.RADICAVAORS.com.
About Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Tanabe Pharma America, Inc. (TPA) is a wholly-owned subsidiary of Tanabe Pharma Corporation (TP). It was established by TP to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit us.tanabe-pharma.com or follow us on X (formerly Twitter), Facebook and LinkedIn.
About Tanabe Pharma Corporation
Tanabe Pharma Corporation (TP) is one of the oldest pharmaceutical companies in the world, founded in 1678. TP is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. TP sets the MISSION of "Creating hope for all facing illness." To that end, TP is working on the disease areas of central nervous system, immuno- inflammation, diabetes and kidney, and cancer. TP is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.tanabe-pharma.co.jp/e/.
Media inquiries:
Media_TPA.US@mb.tanabe-pharma.com
1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Tanabe Pharma America, Inc.; 2022
2 Data on file. Tanabe Pharma America, Inc.
3 Data on file. Tanabe Pharma America, Inc.
4 Data on file. Tanabe Pharma America, Inc.
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SOURCE Tanabe Pharma America