New Oral Pill Cuts "Bad" Cholesterol by 60%, Matching Injectable Drugs

A new oral medication called enlicitide has demonstrated remarkable effectiveness in reducing LDL cholesterol — commonly known as "bad" cholesterol — by approximately 60 percent in a major phase 3 clinical trial. The results, which match the effectiveness of existing injectable therapies, could represent the most significant advance in cholesterol management since the development of statins.

The trial enrolled 2,909 patients with established atherosclerotic cardiovascular disease or at elevated risk, making it one of the largest studies of its kind. After 24 weeks of treatment, patients taking enlicitide experienced an average 58.2 percent drop in LDL cholesterol levels, a reduction that researchers described as unprecedented for an oral medication.

“The results, which match the effectiveness of existing injectable therapies, could represent the most significant advance in cholesterol management since the development of statins.”

Enlicitide works by targeting the PCSK9 pathway, the same biological mechanism used by injectable drugs like evolocumab and alirocumab. However, while those medications require regular injections — typically every two to four weeks — enlicitide achieves comparable results through a simple daily pill. This convenience factor could dramatically increase patient adherence and access to effective cholesterol management.

Cardiologists have hailed the results as potentially transformative. High LDL cholesterol is one of the primary risk factors for heart attacks and strokes, which remain the leading causes of death globally. While statins have been the backbone of cholesterol treatment for decades, many patients cannot achieve adequate LDL reduction with statins alone, and the injectable alternatives, despite their effectiveness, face barriers related to cost, access, and patient willingness to self-inject.

The U.S. Food and Drug Administration has recognized enlicitide's potential by adding it to its program for ultra-fast reviews, suggesting that the drug could reach patients sooner than the typical regulatory timeline would allow. This expedited pathway reflects both the strength of the clinical data and the significant unmet medical need for better oral cholesterol-lowering options.

Merck, the pharmaceutical company behind enlicitide, has described the drug as a potential paradigm shift in cardiovascular medicine. If approved, it would give physicians and patients a powerful new tool in the fight against heart disease — one that combines the potency of injectable PCSK9 inhibitors with the simplicity and accessibility of a daily pill.