The U.S. Food and Drug Administration approved Merck's cholesterol pill Lipfendra on July 16, 2026 [3].
This approval introduces the first once-daily oral PCSK9 inhibitor in the U.S. [4], offering a convenient alternative to existing injectable therapies for high-risk patients and adults with high cholesterol [1, 2].
Lipfendra, also known as enlicitide, is designed to lower LDL cholesterol through a daily tablet [1, 5]. Clinical trials demonstrated that the medication can achieve a reduction in LDL cholesterol of up to 60% [1].
"This approval marks a historic moment in cardiovascular care, giving patients a convenient oral option to lower LDL cholesterol," Robert Davis, Merck chief scientific officer, said.
The FDA issued the approval in Washington, D.C., to expand the options available for managing cardiovascular risk [1, 2]. Previous PCSK9 inhibitors required injections, which some patients found burdensome or avoided entirely.
"The FDA is pleased to approve Lipfendra, the first oral PCSK9 inhibitor, which has demonstrated up to a 60% reduction in LDL cholesterol in clinical trials," Robert Califf, FDA Commissioner, said.
Medical professionals expect the pill to be used in conjunction with lifestyle changes. Dr. Emily Chen, a cardiologist at the Mayo Clinic, said patients can now manage their cholesterol with a daily pill alongside diet and exercise.
The drug targets a specific protein that helps the liver clear LDL cholesterol from the blood. By inhibiting this protein, Lipfendra allows the body to more effectively remove harmful cholesterol from the bloodstream [1, 2].
“"This approval marks a historic moment in cardiovascular care..."”
The transition of PCSK9 inhibitors from injectable to oral form removes a significant barrier to treatment adherence. By offering a once-daily pill that matches the efficacy of more invasive methods, the medical community can more aggressively treat high-risk cardiovascular patients who previously declined injections.
