Motilin Receptor Agonists for Diabetic Gastroperesis

胃动素受体激动剂治疗糖尿病胃溃疡

• 批准号: 7006837
• 负责人: DAVID C MYLES
• 金额: $ 10万
• 依托单位: KOSAN BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-22 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7006837
• 关键词: diabetes mellitus; dogs; drug design /synthesis /production; gastrointestinal agents; gastrointestinal hormones; hormone receptor; laboratory mouse; laboratory rabbit; medical complication; paralysis; stimulant /agonist; stomach

DESCRIPTION (provided by applicant): The overall goal of this Fast-Track application is to develop a therapeutic agent for the treatment of diabetic gastroparesis that can be used effectively several times a day with meals to avoid the discomfort associated with slow emptying of stomach contents. Because this agent addresses a symptom rather than the underlying disease itself, it is important for the drug to maintain efficacy throughout the chronic administration required for successful treatment. The clinical candidate selected in Phase I of this research will be advanced toward human clinical trials in Phase II. The overall objectives of the Phase II portion of the application are the demonstration of in vivo efficacy upon repeat dosing in a dog gastric emptying model and the execution of all studies required for the completion of a well-supported investigational new drug application (IND) to the Food and Drug Administration.

描述(申请人提供)：本快速通道申请的总体目标是开发一种治疗糖尿病胃轻瘫的治疗剂，可有效地在一天内随餐多次使用，以避免与胃内容物排空缓慢相关的不适。由于这种药物针对的是症状而不是潜在疾病本身，因此对该药物来说，在成功治疗所需的整个慢性给药过程中保持疗效是很重要的。在这项研究的第一阶段中选择的临床候选药物将在第二阶段进入人体临床试验。应用程序第二阶段部分的总体目标是在狗的胃排空模型中证明重复给药的体内疗效，并执行完成向食品和药物管理局提交的得到良好支持的研究性新药申请(IND)所需的所有研究。