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This product is only approved in Japan and is not being studied by Asahi Kasei Therapeutics Corp. in the U.S. or Europe.
Asahi Kasei Therapeutics Corp., the Japanese-based pharmaceutical subsidiary of diversified global company Asahi Kasei, has announced the initiation of a domestic Phase III clinical trial. The trial will evaluate Teribone™ (teriparatide acetate) in patients with severe osteoporosis who require continued treatment beyond the current duration limit.
Osteoporosis is a progressive disease characterized by reduced bone strength and an increased risk of fracture. For patients with severe osteoporosis, long-term continuous treatment is often required to maintain bone density and limit disease progression. However, treatment options that support sustained bone formation over extended periods of time remain limited and represent a significant unmet medical need. The Phase III trial1 in Japan is designed to evaluate the efficacy and safety of continued Teribone™ administration in patients with osteoporosis at high risk of fracture who have already completed 24 months of teriparatide treatment and continue to demonstrate a clinical need.
Teribone™ is a human parathyroid hormone (PTH) preparation manufactured by Asahi Kasei Therapeutics Corp. With administration either once per week (56.5 μg) or twice per week (28.2 μg), it promotes bone formation and increases bone mass, thereby enhancing bone strength while reducing fracture risk.
Based on findings from non-clinical studies, teriparatide preparations such as Teribone™ are currently limited to a maximum treatment of 24 months in Japan. However, this limitation poses a challenge for patients who require extended treatment to promote bone formation. Addressing this has been a longstanding challenge for the pharmaceutical industry.
Daisuke Okajima, President of Asahi Kasei Therapeutics Corp., commented: “This trial is an important step towards the prolonged administration of Teribone™ to patients with a high risk of bone fracture due to osteoporosis. We aim to meet the expectations of the clinical community with scientific evidence and to realize better treatment options for each and every patient.”
Asahi Kasei positions Pharmaceuticals as a First Priority business in its medium-term management plan, emphasizing value creation by expanding its research and development activities globally to deliver innovative therapeutic options worldwide.
1 Trial ID: jRCT2031260049
About Asahi Kasei
Asahi Kasei is a diversified global company that contributes to life and living for people around the world. Since its foundation in 1922, with businesses in ammonia and cellulose fiber, Asahi Kasei has consistently grown through proactive portfolio transformation to meet the evolving needs of every age. With 50,000 employees worldwide, the company contributes to sustainability by providing solutions to the world’s challenges across its three business sectors: Healthcare, Homes, and Material. For more information, visit https://www.asahi-kasei.com/.