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In July 2026, the U.S. FDA approved enlicitide (Lipfendra) as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
PCSK9-directed therapies lower LDL cholesterol by increasing the availability of hepatic LDL receptors. Until now, all approved agents in this class have been injectable. Enlicitide is the first approved oral PCSK9 inhibitor.
The approval was based on two randomized, placebo-controlled trials evaluating enlicitide 20 mg once daily for 52 weeks in patients receiving stable lipid-lowering therapy. One trial involved 2900 adults with or without HeFH who had elevated LDL cholesterol (mean, 96 mg/dl)…