BrightGene’s BGM1812 injection receives U.S. FDA clearance for clinical trials

On September 29, 2025, BrightGene announced that its BGM1812 injection for the treatment of overweight or obesity had been approved by the U.S. FDA for Phase I clinical trials. BGM1812 is a novel, long-acting Amylin analog optimally designed by BrightGene, demonstrating excellent molecular activity and pharmaceutical stability.

Amylin, a 37-amino acid satiety peptide hormone, is co-released with insulin from pancreatic β-cells into the bloodstream. It suppresses appetite by activating central satiety pathways in the brain, while also delaying gastric emptying and inhibiting glucagon secretion, embodying a multi-mechanistic approach to weight management.