China-based Gan & Lee Pharmaceuticals (SHA: 603087) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase II study for its investigational drug GZR18 in treating obesity and overweight conditions, with and without type 2 diabetes (T2D).
GZR18: A Promising GLP-1 Receptor Agonist for T2D and Weight Management
GZR18 is an in-house developed long-acting glucagon-like peptide-1 (GLP-1) receptor agonist by Gan & Lee Pharmaceuticals. The drug is being developed for use in type 2 diabetes and weight management. GZR18 has previously completed a Phase II trial in China, where it demonstrated effective hypoglycemic and weight loss effects when administered on a weekly or biweekly basis.
Implications of the FDA Approval
The FDA’s green light for the Phase II study is a significant milestone for Gan & Lee Pharmaceuticals, as it indicates the potential for GZR18 to be considered for the treatment of obesity and related metabolic disorders in the United States. This approval also underscores the growing interest in GLP-1 receptor agonists as a therapeutic option for weight management and glycemic control, particularly for patients with type 2 diabetes.-Fineline Info & Tech