FDA Approves Lipfendra for High Cholesterol Treatment

The FDA approved Lipfendra (enlicitide) on July 16, 2026, as the first oral PCSK9 inhibitor for treating high cholesterol and heterozygous familial hypercholesterolemia.

Clinical trials showed the 20mg daily pill lowered LDL cholesterol by 56% to 59% in patients, often when used alongside statin therapy.

While Lipfendra targets the same biological pathway as injectable PCSK9 inhibitors, it offers a daily oral alternative for patients who do not reach target cholesterol levels with statins alone.