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• Ono and Seikagaku have signed a definitive agreement related to co-development and marketing collaboration on Gel-One for the treatment of osteoarthritis in Japan;
• Gel-One is currently undergoing Phase III clinical studies and long-term safety study in Japan.
Ono Pharmaceutical Co., Ltd (Headquarters: Osaka, Japan, President and COO: Toichi Takino; ”Ono”) today announced that it has entered into a definitive agreement with Seikagaku Corporation (Tokyo, Japan, President and CEO: Ken Mizutani; “Seikagaku”) (seikagaku.co.jp), based on the discussions held related to co-development and marketing collaboration on Gel-One under development by Seikagaku for the treatment of osteoarthritis in Japan, as stated in the press release dated April 25, 2025,"Ono Enters into a Basic Agreement with Seikagaku for Co-development and Marketing Collaboration on Gel-One for the Treatment of Osteoarthritis in Japan."
Under the agreement, Ono acquires co-development and exclusive marketing rights related to Gel-One in Japan. Ono will pay Seikagaku tiered royalties over multiple years based on future progress in development and marketing.
In Japan, three Phase III clinical studies are underway, a study for osteoarthritis of the knee, a study for osteoarthritis of the hip, and a long-term safety study for both joints. The companies are committed to facilitating these clinical studies as quickly as possible to obtain an approval for manufacturing and marketing authorization for the product at an earlier date.
About Gel-One for the treatment of osteoarthritis
Gel-One is an intra-articular injection whose main ingredient is a cross-linked hyaluronate, utilizing Seikagaku’s unique cross-linking technology. Since Gel-One remains in the joint for a long period of time, a single injection of Gel-One is expected to provide long-term pain relief. The product has been available in overseas markets since 2012 as Gel-one® (U.S.) and HyLink® (Taiwan and Italy) indicated for osteoarthritis of the knee. Additionally, whereas the indication for Gel-One in overseas markets is the knee joint, in Japan, Seikagaku will concurrently conduct a study of Gel-One for osteoarthritis of the hip alongside the knee study with the aim of expanding the target patient population.
About Ono Pharmaceutical Co., Ltd
Ono Pharmaceutical Co., Ltd (ono-pharma.com) delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care.
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