Tanabe Pharma America Announces Finalization of RADICAVA (edaravone) Transfer to Shionogi

Tanabe Pharma America Remains Focused on Rare Disease Innovation and Addressing Unmet Patient Needs

JERSEY CITY, N.J., April 1, 2026 /PRNewswire/ -- Tanabe Pharma America, Inc. (TPA), the wholly owned subsidiary of Tanabe Pharma Corporation, today announced the finalization of the transfer of the RADICAVA (edaravone) business to Shionogi Inc. (SI). TPA previously announced the transfer on December 22, 2025. This critical milestone ensures continued strength and strategic alignment for RADICAVA, a leading therapy for amyotrophic lateral sclerosis (ALS).

Effective immediately, the RADICAVA business, including intellectual property rights and marketing rights in key countries and regions, has officially transitioned to SI. For certain countries and regions, rights will be transferred sequentially following the prescribed procedures. This strategic move supports the long-term growth and sustainability of the brand by solidifying RADICAVA's future within a company recognized for its commitment to the research and development of innovative medicines that address unmet medical needs for people worldwide.

"We are incredibly proud of the achievements we have accomplished in bringing RADICAVA to patients living with ALS, and today marks both a meaningful milestone and an exciting new beginning," said Yasutoshi Kawakami, President, TPA. "This finalization allows TPA to focus on driving discoveries through innovative science with a late-stage pipeline of investigational treatments for difficult-to-treat diseases."

Unwavering Commitment to Patients: Continuity of Care
TPA's foremost priority throughout this process has been to ensure continuity for patients who take RADICAVA and their caregivers. This transition has been planned and executed to minimize disruption to patient care and access.

• Supply Chain & Product Availability: There will be no changes to the current supply chain, and patients can expect continuity in product availability for RADICAVA.
• Patient Support Services: All established patient support services will remain fully operational and accessible. TPA's commitment to providing comprehensive assistance to patients and their families is unwavering, and the support patients have come to expect will continue seamlessly.
• Adverse Event Reporting: The process established to report adverse events relating to RADICAVA will remain unchanged. Healthcare providers and patients should continue to report suspected adverse events at 1-888-292-0058, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• Customer-Facing Contacts: All key customer-facing contacts for healthcare providers and patients remain unchanged, including but not limited to contacts for the trade, payer, clinical educators, live call center education, patient advocacy, corporate communications, managers of patient access, medical science liaison, and sales teams.

A Sharpened Focus on Innovation
For TPA America and the broader Tanabe Pharma Group, this strategic move strengthens the companies' financial foundation and sharpens focus on advancing a promising pipeline of assets and core therapeutic areas, including treatments addressing significant unmet medical needs.

Guided by its mission, "Creating hope for all facing illness," TPA will continue to pursue innovation through internal research and strategic partnerships, identifying and advancing meaningful therapies to patients.

TPA's experience developing innovative treatments in North America, combined with the backing of Tanabe Pharma Corporation, positions the company to move quickly and purposefully in pursuit of its pipeline goals.

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 22,000 people with ALS, with over 2.8-million days of therapy, and have been prescribed by over 2,800 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. It was established by Tanabe Pharma Corporation to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit https://us.tanabe-pharma.com or follow us on X (formerly Twitter), Facebook and LinkedIn.

About Tanabe Pharma Corporation, Inc.
Tanabe Pharma Corporation is one of the oldest pharmaceutical companies in the world, founded in 1678. Tanabe Pharma is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. Tanabe Pharma sets the MISSION of "Creating hope for all facing illness." To that end, Tanabe Pharma is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. Tanabe Pharma 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.com/en.

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1. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Tanabe Pharma America, Inc.; 2025.
2. Data on file. Tanabe Pharma America, Inc.
3. Data on file. Tanabe Pharma America, Inc.
4. Data on file. Tanabe Pharma America, Inc.

SOURCE Tanabe Pharma America