AstraZeneca's GCGR/GLP-1R Dual Agonist Cotadutide Receives CDE Acceptance for Clinical Trial Application in China

Source: Pharma Observer

Recently, the official website of the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) indicated that AstraZeneca's clinical trial application for the Class 1 innovative drug cotadutide injection has been accepted. According to public information, cotadutide is a dual agonist of the glucagon receptor (GCGR) and the glucagon-like peptide-1 receptor (GLP-1R), and its global development has progressed to Phase 2 clinical trials.

Screenshot source: CDE official website

GCGR and GLP-1R are members of the G protein-coupled receptor family, serving as two important "regulators" for maintaining blood glucose homeostasis in the human body: in the fasting state, GCGR binds to its ligand, glucagon, to elevate blood glucose levels; whereas GLP-1R primarily acts in the postprandial state, binding to its ligand, glucagon-like peptide-1, to stimulate insulin secretion, thereby lowering postprandial blood glucose and maintaining it within the normal range. Currently, the development of dual agonists targeting GCGR/GLP-1R has emerged as a novel therapeutic direction for diseases such as diabetes, obesity, and nonalcoholic steatohepatitis (NASH).

According to AstraZeneca's official website, cotadutide is a dual GCGR and GLP-1R agonist with multiple mechanisms of action. It not only enhances insulin secretion and reduces food intake by activating the GLP-1 receptor, but also reduces inflammation and lipogenesis by activating the glucagon receptor. Currently, the product is under development for therapeutic areas including type 2 diabetes, obesity, NASH, and diabetic nephropathy.

Previously, cotadutide had preliminarily demonstrated in a randomized, double-blind, Phase 2a study in patients with type 2 diabetes that its glucose-lowering effect is mediated by enhanced insulin secretion and delayed gastric emptying. Further clinical study results indicated that in overweight patients with type 2 diabetes and fatty liver, cotadutide demonstrated efficacy in reducing hepatic fat levels and alleviating hepatic fibrosis.

▲ Introduction to Cotadutide (Image source: AstraZeneca official website)

According to the ClinicalTrials website, AstraZeneca has conducted multiple clinical trials in patients with type 2 diabetes, including those with chronic kidney disease and type 2 diabetes, as well as patients with obesity and type 2 diabetes. Additionally, the company has initiated a Phase 2 study to evaluate the safety and efficacy of cotadutide in subjects with nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH).

We hope that AstraZeneca's development programs for cotadutide will progress smoothly, soon bringing new treatment options and benefits to more patients.

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