Ezetimibe

iStock, Dragon Claws Merck is eyeing a quick review for its lipid-lowering drug candidate enlicitide, which in December was awarded a Commissioner’s National Priority Voucher. Merck’s cholesterol-lowering pill, which late last year received a Commissioner’s National Priority Voucher, significantly outperformed other oral non-statin drugs in patients with hypercholesterolemia, results that analysts say paint a “competitive” pro the pharma’s asset. Merck’s drug candidate, dubbed enlicitide, has “antibody-like efficacy,” RBC Capital Markets told investors in a note on Monday, pointing to the pill’s “strong efficacy” versus comparators. “There are no surprises in this data, which should cement enlicitide’s place in the market.” Consensus estimates put 2034 sales for enlicitide at around $4 billion, according to the note, but RBC is more optimistic and forecasts $5 billion in earnings that year, though “pricing will be critical for uptake.” In December 2025, the drug was granted the Commissioner’s National Priority Voucher, a regulatory ticket that aims to cut down the FDA’s review period to 1-2 months from the usual 10-12 months. With the voucher, RBC estimated on Monday that Merck could enlicitide’s approval by summer “and secure approval in fall 2026,” though the pharma hasn’t laid out a specific timeline for a submission. FDA 9 Months In, FDA’s New Priority Voucher Program Still Clouded With Uncertainty The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher. March 23, 2026 · 7 min read · Heather McKenzie Read more That submission will be supported by the new results, from the Phase 3 CORALreef AddOn trial in which Merck pitted enlicitide against Organon’s Zetia and Esperion’s Nexletol and Nexlizet in more than 300 patients with hypercholesterolemia. All study participants were on background statin therapy. Results showed that at eight weeks, enlicitide cut low-density lipoprotein cholesterol (LDL-C) concentrations by 56.7% versus Nexletol and by 36% versus Zetia. Compared with Nexlizet, which combines the active ingredients of Zetia and Nexletol, enlicitide elicited a 28.1% greater reduction in LDL-C. All three comparisons achieved statistical significance in favor of enlicitide, according to Merck’s news release. Aside from lowering LDL-C, enlicitide also significantly lowered apolipoprotein B levels versus the active comparators, a key study outcome. As for safety, Merck’s pill did not trigger a clinically meaningful excess of adverse events versus the control drugs. There were no serious toxicities attributed to enlicitide. These findings were presented Monday at the 2026 Scientific Session and Expo of the American College of Cardiology. Designed to be taken orally, enlicitide works by blocking the PCSK9 enzyme, in turn lowering LDL-C levels. Merck is building its case for enlicitide through the comprehensive Phase 3 CORALreef program, which spans more than 19,000 patients with hypercholesterolemia. Aside from CORALreef AddOn, the program involves two more pivotal trials: CORALreef Lipids and CORALreef HeFH, both of which have already read out. Data from the former, presented in November 2025 , showed a 55.8% LDL-C reduction versus placebo at 24 weeks. The latter, meanwhile, toplined in June that year though Merck did not release specific data at the time.

Merck had held back detailed data from the Coralreef AddOn study.\n Merck & Co. has lifted the lid on the third successful phase 3 trial of its PCSK9 inhibitor, showing the edge the cardiovascular disease prospect has over other oral non-statin therapies.Last year, Merck said the study, dubbed Coralreef AddOn, met its primary and key secondary endpoints, but the company kept the data back for a medical meeting. The Big Pharma arrived at the American College of Cardiology’s annual get-together clutching the data, which show its oral macrocyclic peptide enlicitide comfortably beat the control treatments across multiple measures of cardiovascular health.Investigators randomized 301 statin-treated adults with atherosclerotic cardiovascular disease to receive enlicitide or one of three control regimens. Patients in the control arms took bempedoic acid, ezetimibe or both approved drugs in combination.On Day 56, LDL cholesterol (LDL-C) had fallen by an average of 64.6% in the enlicitide cohort. Patients on the combination of bempedoic acid and ezetimibe had the next biggest decline in LDL-C, but the drop lagged well behind the study drug at 36.5%. Enlicitide drove deeper declines than the control treatments in apolipoprotein B (ApoB) and non-HDL cholesterol (non-HDL-C), hitting key secondary endpoints. Specifically, enlicitide reduced ApoB by 54.6%, compared to the next largest reduction of 27.7% from bempedoic acid with ezetimibe combined. Meanwhile, the study drug was linked to a 58.0% drop in non-HDL-C compared to the next-best reduction of 31.8% for bempedoic acid and ezetimibe.Merck’s abstract lacked detailed safety and tolerability data. The company said the drug candidate was well-tolerated, a finding that is in line with the results of its other studies. Enlicitide had a placebo-like safety profile in Coralreef Lipids, another of Merck’s three successful phase 3 trials. After reviewing the Coralreef Lipids results last year, Guggenheim Securities analysts said in a note to investors that they see a path for enlicitide sales to exceed the $2.8 billion consensus revenue estimate for 2033. The analysts and their peers at BMO Capital Markets both noted the need for patients to take enlicitide on an empty stomach as a potential issue, although adherence was high in the phase 3 trials.“The consistency of the results from CORALreef AddOn, together with the data from CORALreef Lipids and CORALreef HeFH, further establish the efficacy and safety profile of enlicitide as a promising potential treatment solution for patients in need of further LDL-C reduction,” Joerg Koglin, M.D., senior vice president, head of general and specialty medicine, global clinical development, Merck Research Laboratories.Merck Chief Financial Officer Caroline Litchfield said at a TD Cowen event on March 3 that the company intended to file for FDA approval of enlicitide imminently. Typically, the timing would position Merck to launch enlicitide early in 2027. However, Merck has received a Commissioner’s National Priority Voucher for enlicitide, leading Litchfield to express hopes that the product could come to market sooner.