The FDA approved Merck’s first oral PCSK9 inhibitor, Lipfendra (enlicitide), expanding cholesterol-lowering options beyond injectable PCSK9 antibodies. The oral macrocyclic peptide is designed to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. Merck positions the treatment within its National Priority Voucher program pathway. In clinical development, enlicitide lowered LDL-C substantially, with trial results described as reducing levels to 50 mg/dL or lower in some patients, alongside safety profiles reported as comparable to placebo. The approval intensifies competition in the PCSK9 class and adds an oral option for patients needing deeper LDL-C reductions, with Merck also conducting studies focused on cardiovascular outcomes.