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Merck’s LIPFENDRA® (enlicitide) is the First and Only Once-Daily Oral PCSK9 Inhibitor Approved by the U.S. FDA to Reduce LDL-C in Adults with Hypercholesterolemia

$MRKPress releaseJul 16, 2026, 6:45 AM ETRead the release

Merck received FDA approval for LIPFENDRA, the first and only once-daily oral PCSK9 inhibitor to reduce LDL-C in adults with hypercholesterolemia. The approval is based on the CORALreef Lipids and HeFH Phase 3 trials, which showed placebo-adjusted LDL-C reductions of 56% and 59% respectively at week 24.

Key figures

Drug Name
LIPFENDRA (enlicitide)
Phase Of Trial
Phase 3
Ldlc reduction coralreef hefh
59%
Ldlc reduction coralreef lipids
56%
Trial enrollment coralreef hefh
303
Trial enrollment coralreef lipids
2904

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