FDA Approves Lipfendra, First Oral Pill to Lower LDL Cholesterol Like an Injection

The FDA approved Lipfendra on July 16, 2026, giving patients with high LDL cholesterol the first oral option in a class of drugs that previously required injections.

Lipfendra, made by Merck under the generic name enlicitide, is a PCSK9 inhibitor. It works by blocking the PCSK9 protein, which normally destroys LDL receptors on liver cells. With more receptors intact, the liver can remove more bad cholesterol from the bloodstream.

Clinical trials showed Lipfendra reduces LDL cholesterol by 56 to 59 percent, comparable to injectable PCSK9 inhibitors like Repatha and Praluent, which have been on the market since 2015. The drug also reduced lipoprotein(a) levels by about 25 percent.

The approval covers adults with high LDL cholesterol and those with heterozygous familial hypercholesterolemia, a genetic condition that causes elevated cholesterol from birth. The drug is meant to be used alongside a healthy diet and exercise.

Lipfendra has a list price of $10.50 per day, or $315 for a 30-day supply. That is lower than the roughly $500 monthly cost of comparable injectable treatments, though actual out-of-pocket costs will depend on insurance coverage.

One limitation: Lipfendra does not yet have the long-term data that injectable PCSK9 inhibitors have accumulated showing reductions in heart attacks and strokes. Large-scale cardiovascular outcome studies are ongoing.

The drug is expected to reach pharmacies within weeks of the approval. Merck said it will work with insurers to ensure access for patients who need it.