FDA Approves Lipfendra, First Oral PCSK9 Inhibitor for High LDL Cholesterol
The FDA approved Lipfendra (enlicitide) on July 16, 2026, making it the first oral PCSK9 inhibitor for adults with high LDL cholesterol. Merck's once-daily pill lowered LDL levels by about 56 percent in clinical trials. The drug is priced at $10.50 per day and is intended for patients who need additional cholesterol reduction beyond what statins provide.
The U.S. Food and Drug Administration approved Lipfendra (enlicitide) on July 16, 2026, making it the first oral PCSK9 inhibitor available for adults with high LDL cholesterol.
Manufactured by Merck, Lipfendra is a once-daily tablet that works by blocking the PCSK9 protein, which allows the liver to remove more LDL cholesterol from the bloodstream. Previous PCSK9 inhibitors, such as Repatha and Praluent, were available only as injections.
In a main clinical trial involving adults with heart disease or high cardiovascular risk, Lipfendra lowered LDL cholesterol by approximately 56 percent after 24 weeks. A second trial focused on patients with heterozygous familial hypercholesterolemia showed a reduction of about 59 percent. The drug also reduced lipoprotein(a) by roughly 25 percent.
The FDA approved Lipfendra for use alongside diet and exercise, with or without a statin, or as a standalone therapy for patients who cannot tolerate statins at needed doses.
Merck set the list price at $10.50 per day, or $315 for a 30-day supply. The company said most patients, including those on Medicare, are expected to pay less, and coupon programs will be available for those with commercial insurance.
Unlike established injectable PCSK9 inhibitors, Lipfendra has not yet been proven in long-term studies to reduce heart attacks or strokes. Trials to assess those outcomes are underway.
