FDA Approves Merck's LIPFENDRA (Enlicitide) 20 mg Tablets Thursday July 16 as the First and Only Once-Daily Oral PCSK9 Inhibitor to Reduce LDL-C in Adults With Hypercholesterolemia (Including Heterozygous Familial Hypercholesterolemia): The Novel Macrocyclic Peptide Delivered 56% Placebo-Adjusted LDL Reduction in the CORALreef Lipids Phase 3 Trial and 59% Reduction in CORALreef HeFH, Matching the Efficacy of Injectable PCSK9 Monoclonal Antibodies at a $315 Per Month List Price Roughly One-Third the Cost of Injectable Repatha and Praluent
The US Food and Drug Administration approved Merck's LIPFENDRA (enlicitide) 20 mg tablets Thursday July 16, 2026 as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). LIPFENDRA is a novel macrocyclic peptide and becomes the first FDA-approved oral PCSK9 inhibitor. In the registrational Phase 3 CORALreef Lipids trial, enlicitide achieved a 56% placebo-adjusted LDL-C reduction; in CORALreef HeFH the reduction was 59%. Every other FDA-approved PCSK9 inhibitor (Amgen's Repatha/evolocumab, Regeneron/Sanofi's Praluent/alirocumab) is delivered by subcutaneous injection every two to four weeks; enlicitide is the first approved as a once-daily oral tablet. Merck priced LIPFENDRA at $315 per month list price, roughly one-third the approximately $700-900/month list prices of the injectable PCSK9 antibodies. The approval extends the macrocyclic peptide platform's clinical validation and opens a new oral chapter for a drug class that had been injectable-only since the first FDA approvals in 2015.