Overview
- The U.S. Food and Drug Administration approved enlicitide, branded Lipfendra, on July 16, 2026 as an add-on treatment for adults with high LDL cholesterol and heterozygous familial hypercholesterolemia.
- Approval relied on two phase 3 CORALreef trials that showed once-daily enlicitide cut LDL cholesterol by about 55–60% versus placebo over six months with serious adverse events similar to placebo.
- Lipfendra works by blocking the liver protein PCSK9, must be taken on an empty stomach, and the most common side effects reported in trials were diarrhea and dizziness.
- Merck set a list price of $315 for a 30-day supply, plans to ship the drug within weeks, and positions the pill as a lower-cost, easier-to-use alternative to injectable PCSK9 therapies that many patients avoid.
- A larger cardiovascular outcomes study that will measure effects on heart attacks, strokes and deaths is ongoing and is expected to report in 2029 while the approval gives Merck a new commercial option ahead of key patent losses on other drugs.