Drug intelligence / Profile preview

ezetimibe + pitavastatin calcium (Dongkook Pharmaceutical)

Development stage
Unknown
Lead developer
Dongkook Pharmaceutical
Modality
Small Molecules
Administration
Oral
01

Overview

DKF-432 is a fixed-dose combination generic drug candidate being developed by Dongkook Pharmaceutical for the treatment of dyslipidemia. It is a generic version of JW Pharmaceutical's Livalojet, combining the HMG-CoA reductase inhibitor pitavastatin calcium (4 mg) with the cholesterol absorption inhibitor ezetimibe (10 mg). Pitavastatin works by inhibiting cholesterol synthesis in the liver, while ezetimibe blocks the absorption of cholesterol in the small intestine. In August 2025, Dongkook Pharmaceutical received approval from the South Korean Ministry of Food and Drug Safety (MFDS) to conduct a bioequivalence study comparing DKF-432 to Livalojet in healthy adult volunteers.

Other names
ezetimibe + pitavastatinpitavastatin + ezetimibepitavastatin calcium + ezetimibe
02

Targets

HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase)NPC1L1 (Niemann-pick C1-Like 1 transporter)

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