0211年Lubiprostone:俄罗斯0211年,SPI。

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0211年Lubiprostone:俄罗斯0211年,SPI。

药物R d . 2005; 6 (4): 245 - 8。

PubMed ID

15991886 (在PubMed

]

文摘

Lubiprostone [RU 0211, SPI 0211]是一个双环脂肪酸,充当一个氯通道开启,增加肠道水分泌。Lubiprostone、通过制定一系列功能性脂肪酸化合物之一Ryuji上野博士发现的,目前正在开发的治疗便秘,肠易激综合症constipation-predominant (IBS-C)和术后肠梗阻Sucampo制药的。Lubiprostone激活特定的氯通道(CLC2)在肠道细胞,从而自然地增加肠道液体分泌。增加液面软化粪便,促进自然排便,减少腹部不适、疼痛和肿胀。氯离子通道是一种蛋白质,控制氯离子的细胞膜运输。Lubiprostone作用于ClC-2氯通道,位于顶端肠膜。2004年11月,武田制药签订了合作和许可协议为Lubiprostone Sucampo医药治疗慢性便秘和constipation-predominant肠易激综合症(c-IBS)。根据协议条款,武田收到正确的市场产品在美国和加拿大,同时为这些国家Sucampo co-promotion权利保留。武田的全资子公司,武田制药北美公司将出售lubiprostone一旦产品被美国FDA批准。武田还将得到一个选择营销权利在其他地区,包括日本和欧洲。 Takeda and Sucampo agreed on the exclusive manufacturing and supply of Lubiprostone by R-Tech Ueno, Ltd, a member of the Sucampo Group. Sucampo has the potential to receive up to dollar US 210 million in initial and milestone payments, some of which are contingent upon the successful achievement of several milestones. Takeda will fund a major part of development costs not only for chronic constipation and c-IBS, but also for other indications in the gastroenterology field. Takeda will make royalty payments to Sucampo after the product is launched. In May 2005, Sucampo received dollar US 20 million from Takeda Pharmaceutical as payment for achieving a development milestone of initiating a phase III clinical trial of lubiprostone to treat patients with constipation-predominant irritable bowel syndrome. Sucampo Pharmaceuticals submitted a new drug application (NDA) for lubiprostone to the FDA on 31 March 2005 for approval in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults. Sucampo completed three long-term, open-label safety studies, which will support the NDA for lubiprostone, in treating constipation. Results from its second open-label safety study with lubiprostone were announced in February 2004, with the first two studies demonstrating long-term safety and sustained effectiveness in constipated subjects. In the US, the final phase III study for chronic constipation was completed in the fourth quarter of 2004. In November 2004, Sucampo announced completing a phase II safety and efficacy study of lubiprostone for the treatment of IBS-C. This study, which was initiated in April 2003, randomised 195 patients with documented IBS into four treatment groups (three doses of SPI 0211 and placebo) from 19 locations throughout the US.

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药物靶点

药物	目标	类	生物	药理作用	行动
Lubiprostone	氯离子通道蛋白2	蛋白质	人类	是的	诱导物	细节