Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects

Gan & Lee Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the company's compound, GZR18, to improve the management of type 2 diabetes mellitus. The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects such as the stimulation of insulin secretion and the inhibition of glucagon, when blood glucose is high.

Currently, there are 537 million adults (20-79 years) living with diabetes worldwide, while type 2 diabetes mellitus accounts for approximately 90% of all diabetes cases. Gan & Lee understands the global burden of type 2 diabetes mellitus. "The FDA's clearance of the IND application for GZR18, is a significant milestone for our company as we strive to globally provide additional treatment options to patients with type 2 diabetes," said Kaushik Dave RPh., PhD, MBA, Vice President, Global Regulatory Affairs. This IND acceptance by the FDA will allow Gan & Lee to proceed with GZR18 Phase 1 clinical trial.

Gan & Lee Pharmaceuticals has developed the first chinese domestic biosynthetic human insulin.