FDA Approves First Oral Cholesterol Pill Lipfendra
The FDA approved Lipfendra (enlicitide) on July 16, 2026, making it the first oral PCSK9 inhibitor for high cholesterol. Developed by Merck, the once-daily pill reduced LDL cholesterol by 56 to 59 percent in clinical trials. The list price is $10.50 per day.
The US Food and Drug Administration approved Lipfendra (enlicitide) on July 16, 2026, giving patients with high cholesterol the first oral PCSK9 inhibitor available as a once-daily pill.
Developed by Merck, Lipfendra works by blocking the PCSK9 protein, which helps the liver remove LDL cholesterol from the bloodstream. All previously approved PCSK9 inhibitors required injection. The pill form offers a new option for patients who are reluctant to use injectable therapies.
The FDA based its approval on two randomized, double-blind, placebo-controlled trials involving 3,207 adults already on maximally tolerated statin therapy. In the first trial, which enrolled adults with established cardiovascular disease or high cardiovascular risk, patients taking Lipfendra saw an average 56 percent reduction in LDL cholesterol at week 24 compared to placebo. In the second trial, which enrolled adults with heterozygous familial hypercholesterolemia, the reduction was 59 percent.
Side effects were generally similar to placebo across both trials. In the second trial, the most commonly reported side effects were dizziness and diarrhea. Discontinuation rates due to adverse events were comparable between treatment and placebo groups.
Lipfendra is intended for patients who need further LDL reduction despite being on maximally tolerated statin therapy. It can be taken alongside or instead of statins.
Merck set the list price at $10.50 per day, or about $315 for a 30-day supply. The company said out-of-pocket costs for many patients, including those on Medicare, are expected to be lower. A coupon program for patients with commercial insurance is in development.
