AG2304R (Ahn-Gook Pharmaceutical Co., Ltd.)

AG2304R is a reference formulation of AG2304, a fixed-dose combination (FDC) therapy being developed by Ahn-Gook Pharmaceutical for the treatment of primary hypercholesterolemia. It consists of rosuvastatin, an HMG-CoA reductase inhibitor (statin), and ezetimibe, a selective cholesterol absorption inhibitor. Rosuvastatin works by inhibiting the rate-limiting enzyme in hepatic cholesterol synthesis, which leads to an increase in low-density lipoprotein (LDL) receptors on the surface of hepatocytes and enhanced uptake and catabolism of LDL. Ezetimibe targets the Niemann-Pick C1-Like 1 (NPC1L1) protein in the small intestine, inhibiting the absorption of dietary and biliary cholesterol. The combination of these two agents provides a synergistic effect on lipid profiles by addressing both endogenous cholesterol production and exogenous cholesterol absorption. AG2304R is utilized as the active comparator (reference) in Phase 3 clinical trials (such as NCT06115330) to evaluate the therapeutic equivalence or superiority of Ahn-Gook's test formulation, AG2304T.

Other names

rosuvastatin + ezetimibe combination