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Drugs. 2017 Aug;77(12):1363-1368. doi: 10.1007/s40265-017-0780-7.
Abaloparatide (Tymlos™) is a synthetic peptide analogue of human parathyroid hormone-related protein that was developed by Radius Health as an osteoanabolic agent for the treatment of postmenopausal osteoporosis. Abaloparatide acts through selective activation of the parathyroid hormone type 1 receptor signalling pathway. In April 2017, subcutaneous abaloparatide received its first global approval, in the USA, for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. A Marketing Authorization Application for subcutaneous abaloparatide for the treatment of postmenopausal women with osteoporosis was accepted by the European Medicines Agency and is currently under review. Radius is also developing a transdermal formulation of abaloparatide, with administration via a microneedle patch. This article summarizes the milestones in the development of abaloparatide leading to this first approval for the treatment of women with postmenopausal osteoporosis.
阿巴洛肽（特立帕肽）是一种合成的人甲状旁腺激素相关蛋白肽类似物，由 Radius Health 开发，作为一种骨合成代谢药物，用于治疗绝经后骨质疏松症。阿巴洛肽通过选择性激活甲状旁腺激素 1 型受体信号通路发挥作用。2017 年 4 月，皮下注射用阿巴洛肽在美国首次获得全球批准，用于治疗有骨折高风险的绝经后骨质疏松症妇女，定义为有骨质疏松性骨折史、多种骨折风险因素或对其他可用骨质疏松症治疗药物不耐受或治疗失败的患者。皮下注射用阿巴洛肽治疗绝经后骨质疏松症的营销授权申请已被欧洲药品管理局接受，目前正在审查中。Radius 还在开发阿巴洛肽的透皮制剂，通过微针贴片给药。本文总结了阿巴洛肽开发过程中的重要里程碑，最终促成了该药首次获批用于治疗绝经后骨质疏松症女性。
