China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity.
HDM1005: A Dual GLP-1 and GIP Receptor Agonist
HDM1005 is a long-acting dual agonist targeting both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. Preclinical studies have demonstrated HDM1005’s ability to activate these receptors, which in turn promotes the production of cyclic adenosine monophosphate (cAMP), increases insulin secretion, suppresses appetite, delays gastric emptying, and improves fat metabolism.
Therapeutic Potential and Safety Profile of HDM1005
The drug has shown potential hypoglycemic, weight loss, and cardiometabolic effects, including improvements in HFpEF. Moreover, existing data indicates that HDM1005 possesses good druggability and safety, which are critical factors for its advancement into clinical trials. The clearance by the FDA is a significant step forward in the development of HDM1005 as a potential treatment for HFpEF and obesity.-Fineline Info & Tech