Motilin Receptor Agonists for Diabetic Gastroperesis

描述（由申请人提供）：本快速通道申请的总体目标是开发一种用于治疗糖尿病胃轻瘫的治疗药物，该药物可每日多次随餐有效使用，以避免胃内容物排空缓慢相关的不适。由于这种药物解决的是症状而不是潜在的疾病本身，因此在成功治疗所需的整个长期给药过程中保持药物的疗效非常重要。本研究I期选择的临床候选药物将在II期进行人体临床试验。本申请II期部分的总体目标是在犬胃排空模型中证明重复给药后的体内疗效，并执行完成向美国食品药品监督管理局提交的得到充分支持的研究性新药申请（IND）所需的所有研究。

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.