A new oral medication has shown LDL reductions of about 55.8%. The experimental drug, Enlicitide, developed by Merck, was presented at the American Heart Association Scientific Sessions 2025, and early results have excited cardiologists around the world.Unlike existing PCSK9 inhibitors, which require injections, Enlicitide is the first oral PCSK9 inhibitor, taken as a once-daily pill. In a late-stage clinical trial, the drug reduced LDL cholesterol by an average of 55–60% in patients already taking statins, numbers comparable to the best injectable treatments currently available.

“This could be a real breakthrough in managing cholesterol, especially for those unable or unwilling to take injectable medications,” said Dr. Christie Ballantyne, lead investigator of the trial.

What did the trial show

The study involved 2,912 adults with an average age of 63, spanning 14 countries between August 2023 and July 2025.

Phase 3 trial results revealed that participants who took the experimental drug Enlicitide alongside standard cholesterol-lowering medications like statins experienced up to a 60% reduction in LDL (“bad”) cholesterol after 24 weeks of daily treatment, compared with those who received a placebo with statins. All participants had elevated LDL levels and were either at high risk of, or had previously experienced, a major cardiovascular event.The findings were presented at the American Heart Association’s Scientific Sessions, and Merck said it will share the data with regulators; several outlets report the company plans an FDA submission in early 2026.

Can the new PCSK9 pill replace statins?

Statins lower LDL by roughly 30–50% depending on intensity, but some patients require additional help to reach safe cholesterol levels. “The two drugs work differently, PCSK9 inhibitors help clear LDL from the blood, while statins block an enzyme in the liver that prompts it to remove more cholesterol. Their dual action makes them effective in stubborn cases” leading cardiologist Dr. Ranjan Shetty, told The Indian Express. Experts say PCSK9 inhibitors are meant to complement, not replace, statins.