Some people find that statins don’t lower their cholesterol level enough. Many of these people with unusually high cholesterol need regular shots of an additional drug to help get their cholesterol to a safe level. A new drug, Lipfendra® (enlicitide), approved in July 2026 by the U.S. Food and Drug Administration, now may offer an easier way.
In this Q&A, Robert Rosenson, MD, a cardiologist and Director of the Metabolism and Lipids Program for the Mount Sinai Health System, explains how the new medicine works, what are some of the benefits, and who this drug might be useful for. Dr. Rosenson is a national leader in researching and treating high cholesterol. He and colleagues at the Mount Sinai Fuster Heart Hospital played a key role in developing this medicine.
What should people know about Lipfendra?
This medicine helps people whose cholesterol is too high, even when they take statins. It’s especially good for people who have a genetic condition that causes high cholesterol. This condition is called hypercholesterolemia. The new drug’s brand name is Lipfendra, and it is also known by its generic name, enlicitide.
What’s different about this medication?
Other medications can also lower cholesterol for those who find statins are not enough. But these other medications require injections every week, month, or every six months. Some drugs require you to give yourself the shots. Enlicitide is different because it is a pill. You take it every morning, along with your statin. This makes it a good choice if you don’t want to get shots or if you have trouble getting to your doctor’s office regularly. Those who want to learn more, especially those already watching their cholesterol, should talk with their doctor about whether this new medicine might help them.
How does it work?
Enlicitide lowers cholesterol by targeting PCSK9, a protein that regulates cholesterol. The drug helps your liver remove more bad cholesterol (called LDL) from your blood. Studies show the new medicine cuts LDL cholesterol by 57 to 59 percent. Lower LDL cholesterol reduces your risk of heart attack, stroke, and other heart problems.
How do you take the new medicine?
Enlicitide works best if you don’t have any food in your stomach. You take the pill first thing in the morning, after not eating for eight hours. Then, don’t eat for the next 30 minutes to give the drug time to work.
Are there any side effects?
Most people don’t have any side effects. Those who do might have diarrhea or dizziness.