A Merck research laboratory in San Francisco.

By Joe Lombardi From Daily Voice

Merck has unveiled a groundbreaking cholesterol-lowering pill, enlicitide, which could transform treatment for millions of Americans struggling with high LDL cholesterol. 

The once-daily oral medication, which targets the PCSK9 protein in the liver, has shown the ability to reduce LDL cholesterol levels by nearly 60 percent in clinical trials, according to results presented Friday, Nov. 7, at the American Heart Association Scientific Sessions 2025.

The pill could be a game-changer in the fight against atherosclerotic cardiovascular disease, the leading cause of death globally.

The pill offers a convenient alternative to existing PCSK9 inhibitors, which are injectable and often cost over $500 per month. 

Enlicitide demonstrated a safety profile comparable to placebo in a Phase 3 trial involving nearly 3,000 participants, including those who were statin-intolerant or unable to meet cholesterol goals with current treatments.

“Enlicitide demonstrated impressive LDL-C reductions with placebo-like safety in the CORALreef Lipids study, underscoring the practice-changing potential of an oral PCSK9 inhibitor,” said Dr. Ann Marie Navar, a lead author of the study and Associate Professor of Medicine at UT Southwestern Medical Center.

The trial also revealed that enlicitide reduced other cardiovascular risk markers, such as ApoB and Lp(a), and led to a 20 percent reduction in heart attack and stroke rates among high-risk patients within the first year of use.

Merck, headquartered in Rahway, New Jersey, plans to seek FDA approval for enlicitide in early 2026.

 If approved, it would be the first oral PCSK9 inhibitor on the market, addressing a significant gap in accessibility for patients who avoid injections or face insurance barriers.

“Enlicitide was designed to deliver PCSK9 antibody-like efficacy and specificity in an easy-to-use pill,” said Dr. Dean Y. Li, president of Merck Research Laboratories. “This moment is the result of Merck’s legacy and commitment to researching ways to help improve ASCVD outcomes for millions worldwide.”