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” profile for 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 file for enlicitide’s approval by summer “and secure approval in fall 2026,” though the pharma hasn’t laid out a specific timeline for a submission.
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.
