Merck announced on Mar. 31 that its cholesterol-lowering pill, enlicitide, delivered significant results in patients with hypercholesterolemia. The drug outperformed other oral non-statin medications in a Phase 3 trial and was described as having "antibody-like efficacy" by RBC Capital Markets.
The findings are important because they suggest enlicitide could become a leading treatment option for people with high cholesterol who need alternatives to statins. According to RBC Capital Markets, "There are no surprises in this data, which should cement enlicitide’s place in the market." Sales estimates for the drug reach up to $5 billion by 2034, though analysts say pricing will be an important factor for uptake.
Enlicitide received the Commissioner’s National Priority Voucher from the Food and Drug Administration (FDA) in December 2025. This regulatory voucher is designed to shorten the review period for new drugs from about ten months to one or two months. With this accelerated timeline, Merck could file for approval by summer and potentially secure approval by fall of 2026, although no specific submission date has been set.
The Phase 3 CORALreef AddOn trial tested enlicitide against Organon’s Zetia and Esperion’s Nexletol and Nexlizet among more than 300 patients already taking statins. Results showed that at eight weeks, enlicitide reduced low-density lipoprotein cholesterol (LDL-C) by up to 56.7% compared with Nexletol and achieved statistically significant reductions versus all comparators. Enlicitide also lowered apolipoprotein B levels without causing serious side effects or toxicities according to Merck's news release.
These results were presented at the American College of Cardiology's Scientific Session and Expo in 2026. Enlicitide works by blocking the PCSK9 enzyme responsible for higher LDL-C levels and is being studied across multiple trials involving over 19,000 patients as part of Merck's CORALreef program.
