Merck's enlicitide (Lipfendra), a once-daily macrocyclic peptide tablet, is FDA-approved for lowering LDL cholesterol, showing engineered peptides can reach targets once reserved for injectable antibodies.
The FDA approved Merck's enlicitide, branded Lipfendra, in July 2026 as the first oral PCSK9 inhibitor for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. It is taken as a 20 mg tablet once daily alongside diet and exercise.
Enlicitide is a macrocyclic peptide engineered to bind PCSK9 and block its interaction with LDL receptors, the same mechanism used by injectable antibodies such as evolocumab and alirocumab. In the Phase 3 CORALreef Lipids and CORALreef HeFH trials, it lowered LDL cholesterol by roughly 56% to 59% versus placebo at 24 weeks.
The approval was based on lipid-lowering endpoints. Whether the drug reduces heart attacks and strokes is being tested in CORALreef Outcomes, which has enrolled more than 14,500 people. For the peptide field, it is a high-profile proof point that oral delivery of large, constrained peptides can work at commercial scale.
Source: TCTMD — Enlicitide FDA Approval
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