Overview
- Merck’s enlicitide, marketed as Lipfendra, was approved by the FDA on Friday, July 17, 2026, and the company says it will be available in the United States in a few weeks.
- Phase III trials showed daily enlicitide cut LDL cholesterol by about 50 to 60 percent versus placebo and produced adverse effects similar to placebo, mainly mild gastrointestinal symptoms.
- The pill is approved for adults with high LDL who remain above goals despite statins or who have familial heterozygous hypercholesterolemia and is intended as an add‑on rather than a statin replacement.
- Merck set a U.S. list price near $315 per 30‑day supply, a level that could influence insurer coverage and how the drug competes with existing injectable PCSK9 therapies.
- A large international outcomes study that will test whether Lipfendra’s LDL cuts translate into fewer heart attacks, strokes, and cardiovascular deaths is ongoing and slated to report in 2029.