Omarigliptin: First Global Approval
Omarigliptin: First Global Approval
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DOI：
10.1007/s40265-015-0493-8
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发表时间：
2015-11-01
期刊：
影响因子：
11.5
通讯作者：
Burness, Celeste B.
中科院分区：
文献类型：
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作者：
Burness, Celeste B.
Omariglitazone [Marizev（R）（Japan）]是一种小分子二肽基肽酶-4（DPP-4）抑制剂，由Merck开发，用于口服治疗2型糖尿病（T2 DM）。与大多数其他批准的同类药物（通常每天给药一次）不同，omariglitazone可以每周给药一次。每周一次的omariglitazone已在日本获得该适应症的首次全球批准，用于成人。该产品的III期临床开发正在其他几个国家进行。本文总结了omariglitazone开发过程中的里程碑，导致首次批准用于治疗T2 DM。
Omarigliptin [Marizev (R) (Japan)] is a smallmolecule dipeptidyl peptidase-4 (DPP-4) inhibitor developed by Merck for the oral treatment of type 2 diabetes (T2DM). Unlike the majority of other approved agents of its class, which are usually administered once daily, omarigliptin can be administered once weekly. Once-weekly omarigliptin has received its first global approval in this indication in Japan, for use in adults. Phase III clinical development of the product is underway in several other countries. This article summarizes the milestones in the development of omarigliptin leading to this first approval for the treatment of T2DM.