FDA Approves Merck's Lipfendra, First Oral PCSK9 Inhibitor for Lowering LDL Cholesterol

The FDA approved Merck's Lipfendra (enlicitide), the first oral PCSK9 inhibitor, on July 16, 2026. The once-daily pill reduced LDL cholesterol by up to 59% in late-stage trials and is intended for use alongside statins. Unlike earlier PCSK9 inhibitors requiring injection, Lipfendra may widen uptake. Merck set the list price above $300 per month, with availability expected within weeks.