DW-5124

DW-5124 is a fixed-dose combination (FDC) small molecule therapy developed by Daewon Pharm for the treatment of hyperlipidemia. It is categorized as an incrementally modified drug (IMD) or a new formulation of a statin and ezetimibe combination. While some clinical trial records in South Korea (e.g., CRIS KCT0006145) have associated the code with a combination of **rosuvastatin** and **ezetimibe**, official records from the South Korean Ministry of Food and Drug Safety (MFDS) identify DW-5124 as a combination of **atorvastatin** and **ezetimibe**. The development of DW-5124 focuses on optimizing the formulation to improve patient compliance, such as through a reduction in tablet size compared to existing marketed versions of these combinations (e.g., Daewon's Crezet or Lipicrezet). The drug utilizes a dual mechanism of action: the statin component (atorvastatin or rosuvastatin) inhibits HMG-CoA reductase to reduce hepatic cholesterol synthesis, while ezetimibe inhibits the Niemann-Pick C1-like 1 (NPC1L1) transporter to block the absorption of dietary and biliary cholesterol in the small intestine. DW-5124 is currently in clinical development in South Korea, primarily undergoing pharmacokinetic and bioequivalence studies.

Other names

atorvastatin + ezetimiberosuvastatin + ezetimibe