Abstract
ONO-5334, an orally-administered low-molecular compound, is a selective synthetic inhibitor of cathepsin K which is specifically expressed in osteoclasts and has a critical role in bone-collagen degradation. ONO-5334 is being developed by Ono Pharmaceutical Co., Ltd. as a possible therapeutic agent for osteoporosis. ONO-5334 has been shown to prevent the decrease in bone mineral density (BMD) in the ovariectomized cynomolgus monkey osteoporosis model. In a 12-month clinical study with postmenopausal osteopenia or osteoporosis, ONO-5334 showed a significant increase in BMD compared with placebo and a similar magnitude of suppression on bone resorption compared with the current well known anti-resorptive agents, bisphosphonates, but with little or no suppression on bone formation. There were no clinically relevant safety concerns identified in this study. Whether this mechanism of action may result in more potent anti-fracture efficacy accompanied by better bone quality in long term use of ONO-5334 is of significant interest.
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