MSD announced its oral PCSK9 inhibitor enlicitide (MK-0616) met primary endpoints in two Phase III CORALreef studies for hypercholesterolemia, making it the first successful late-stage oral PCSK9 inhibitor. The cyclic peptide demonstrated superior LDL-C reduction versus placebo and non-statin comparatives in heterozygous familial hypercholesterolemia (HeFH) and ASCVD-risk patients.

The 20 mg once-daily therapy showed comparable safety profiles to controls across both trials. If approved, enlicitide would become the first oral PCSK9 inhibitor available in MSD's US homeland, offering antibody-like efficacy via validated mechanisms. Detailed results will be presented at future scientific conferences.