Lubiprostone: RU 0211, SPI 0211。

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Lubiprostone: RU 0211, SPI 0211。

药物研究，2005;6(4):245-8。

PubMed ID

15991886 (PubMed视图

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摘要

Lubiprostone [RU 0211, SPI 0211]是一种双环脂肪酸，可作为氯通道打开器，增加肠道水分分泌。Lubiprostone是一种口服配方，是Ryuji Ueno博士发现的一系列功能性脂肪酸化合物之一，目前正在与Sucampo制药公司共同开发用于治疗便秘、便秘型肠易激综合征(IBS-C)和术后肠梗阻。Lubiprostone激活肠道细胞上的特定氯离子通道(CLC2)，从而自然地增加肠液分泌。增加的液体水平软化大便，促进自发排便，并减轻腹部不适/疼痛和腹胀。氯离子通道是一种控制氯离子细胞膜转运的蛋白质。Lubiprostone作用于位于肠顶端膜的ClC-2氯通道。2004年11月，武田制药与Sucampo制药公司就Lubiprostone达成合作和许可协议，用于治疗慢性便秘和便秘型肠易激综合征(c-IBS)。根据协议条款，武田获得了在美国和加拿大销售该产品的权利，而Sucampo则保留了在这些国家的联合推广权。武田制药的美国全资子公司武田制药北美公司将在该产品获得美国FDA批准后销售lubiprostone。武田还将获得在日本和欧洲等其他地区的营销权。 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.

引用本文的药物库数据

药物靶点

药物	目标	种类	生物	药理作用	行动
Lubiprostone	氯通道蛋白2	蛋白质	人类	是的	诱导物	细节