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Drugs. 2018 Mar;78(4):513-519. doi: 10.1007/s40265-018-0878-6.
Ertugliflozin (Steglatro™) is an orally active sodium glucose co-transporter type 2 inhibitor being developed by Merck and Pfizer as a treatment for type 2 diabetes mellitus (T2DM). Ertugliflozin as monotherapy and in combination with various other antidiabetic drugs was associated with improvements in glycaemic control and secondary outcome measures in the VERTIS phase III clinical trial program. Ertugliflozin and fixed-dose combinations of ertugliflozin and metformin (Segluromet™) and ertugliflozin and sitagliptin (Steglujan™) have recently been approved by the US FDA as an adjunct to diet and exercise to improve glycaemic control in adults with T2DM. These products have also received a positive opinion from the EU Committee for Medicinal Products for Human Use (CHMP). This article summarizes the milestones in the development of ertugliflozin leading to its first approval for T2DM.
依格列净（Steglatro™）是一种新型的口服钠-葡萄糖协同转运蛋白 2 抑制剂，由默克公司和辉瑞公司联合开发，用于治疗 2 型糖尿病（T2DM）。依格列净单药治疗以及与各种其他抗糖尿病药物联合使用，在 VERTIS 三期临床试验项目中均显示出改善血糖控制和次要终点的作用。依格列净和依格列净与二甲双胍（Segluromet™）的固定剂量组合以及依格列净与西他列汀（Steglujan™）的固定剂量组合最近已获得美国 FDA 批准，作为饮食和运动的辅助手段，用于改善 T2DM 成人的血糖控制。这些产品也得到了人用药品委员会（CHMP）的积极意见。本文总结了依格列净开发过程中的重要里程碑，最终使其获得 T2DM 的首个批准。
