Plecanatide: First Global Approval
Plecanatide: First Global Approval
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Plecanatide：首次全球批准
DOI：
10.1007/s40265-017-0718-0
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发表时间：
2017-04-01
期刊：
影响因子：
11.5
通讯作者：
Syed, Yahiya Y.
中科院分区：
文献类型：
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作者：
Al-Salama, Zaina T.;Syed, Yahiya Y.
Plecanaline（Trulance TM）是一种口服鸟苷酸环化酶-C激动剂，由Synergy Pharmaceuticals开发，用于治疗胃肠道疾病，如慢性特发性便秘（CIC）和伴有便秘的肠易激综合征（IBS-C）。它是人尿鸟苷素的合成类似物，尿鸟苷素是一种16个氨基酸的肽，调节胃肠道中的离子和液体转运。2017年1月，plecanaline在美国获得了全球首个批准，用于治疗成人CIC患者。Plecanetine正在IBS-C中进行III期研究。本文总结了plecanetin开发过程中的里程碑，导致CIC首次批准。
Plecanatide (Trulance TM) is an oral guanylate cyclase-C agonist that is being developed by Synergy Pharmaceuticals for the treatment of gastrointestinal disorders, such as chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It is a synthetic analogue of human uroguanylin, a 16 amino acid peptide that regulates ion and fluid transport in the gastrointestinal tract. In January 2017, plecanatide received its first global approval in the USA for the treatment of adult patients with CIC. Plecanatide is undergoing phase III investigation in IBS-C. This article summarizes the milestones in the development of plecanatide leading to this first approval in CIC.