Shionogi to purchase the rights and assets of the global RADICAVA business establishing a strong commercial platform in rare disease to support future launches
Shionogi and Co., Ltd., headquartered in Osaka, Japan, has announced that its Board of Directors approved a strategic acquisition related to RADICAVA ORS and intravenous RADICAVA at a meeting held on December 22, 2025. The company plans to acquire a newly formed entity that Tanabe Pharma Corporation will establish specifically to hold the global rights to these products. Tanabe Pharma, also based in Osaka and led by Chief Executive Officer Akihisa Harada, will create the new company, after which Shionogi will acquire full ownership by purchasing all of its shares. The agreement between the two companies was finalized on the same day, and a U.S. business entity currently managing RADICAVA operations will transition into a wholly owned subsidiary of Shionogi Inc.
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RADICAVA ORS is approved by the U.S. Food and Drug Administration and multiple international regulatory authorities for the treatment of amyotrophic lateral sclerosis, a progressive neurological condition with limited therapeutic options. Both the oral suspension and the intravenous formulation have been prescribed to more than 20,000 individuals living with ALS in the United States, reflecting their established role in clinical care.
Isao Teshirogi, Ph.D., President and Chief Executive Officer of Shionogi, shared that bringing RADICAVA into the company’s portfolio is both an honor and a responsibility. He noted that the medicine was developed to ease the burden of a devastating disease and emphasized Shionogi’s commitment to maintaining strong relationships with patients, healthcare providers, and advocacy communities. Teshirogi added that the company is mindful of the trust placed in widely used therapies and intends to manage the product with long term patient benefit in mind.
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Nathan McCutcheon, President and Chief Executive Officer of Shionogi Inc., stated that the planned acquisition represents a significant step forward for the company’s U.S. operations. He explained that welcoming the RADICAVA team and product strengthens Shionogi’s foundation in rare diseases and adds immediate operational capabilities. McCutcheon also highlighted that this infrastructure will support upcoming launches and development programs in areas such as Fragile X syndrome, Jordan’s Syndrome, and Pompe disease.
Shionogi has identified contributing to healthier and more fulfilling lives as a core priority within its corporate strategy. As part of this vision, the company has focused its research and development efforts on conditions with substantial unmet needs, referred to internally as high social impact quality of life disorders. Rare diseases are a key component of this focus, alongside areas such as sleep disorders and hearing loss. The acquisition supports this strategy by creating a commercial platform capable of delivering future rare disease therapies as they receive regulatory approval.
Through this transaction, Shionogi will secure full global marketing rights for RADICAVA ORS and IV RADICAVA, establish a strong commercial presence in the U.S. rare disease market, and integrate experienced professionals with deep expertise in this field. The financial terms include an upfront payment of 2.5 billion U.S. dollars to Tanabe Pharma, made through Shionogi Inc., with the potential for additional royalty payments based on future sales under certain conditions. The closing of the transaction is expected on or after April 1, 2026, and the company anticipates that the acquisition will have a minimal impact on its consolidated financial results for the fiscal year ending March 31, 2026.
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