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K-924 HD, branded as Livalozet HD in Japan, is a high-dose fixed-dose combination (FDC) tablet developed by Kowa Company, Ltd. for the treatment of hypercholesterolemia and familial hypercholesterolemia. It contains 4 mg of pitavastatin calcium and 10 mg of ezetimibe. Pitavastatin is a potent HMG-CoA reductase inhibitor (statin) that reduces hepatic cholesterol synthesis and increases the expression of LDL receptors on the surface of hepatocytes, thereby enhancing the clearance of LDL-C from the blood. Ezetimibe is a selective cholesterol absorption inhibitor that targets the Niemann-Pick C1-Like 1 (NPC1L1) transporter in the brush border of the small intestine, reducing the delivery of dietary and biliary cholesterol to the liver. By combining these two complementary mechanisms—inhibiting both endogenous synthesis and exogenous absorption—the drug achieves significant reductions in LDL-C levels compared to statin monotherapy. It is specifically indicated for patients who have not achieved adequate LDL-C control with statin monotherapy alone. The drug was approved in Japan in 2022.
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