July 16, 2026
1 min read
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Merck and the FDA announced the approval of enlicitide 20 mg as an add-on to diet and exercise to lower LDL in adults with hypercholesterolemia and those with heterozygous familial hypercholesterolemia.Enlicitide (Lipfendra), a novel macrocyclic peptide, is the first oral PCSK9 inhibitor FDA-approved to lower LDL, according to press releases from the company and the FDA.
July 16, 2026
1 min read
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With enlicitide, large LDL cholesterol reductions possible without a needle

The FDA has approved Merck's once-daily cholesterol pill Lipfendra (enlicitide), marking the first oral PCSK9 inhibitor.

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, on July 16, 2026.

Merck's Lipfendra wins FDA approval as the first oral PCSK9 inhibitor for adults with high LDL cholesterol after positive Phase 3…

The FDA has approved Lipfendra, an oral PCSK9 inhibitor, for high cholesterol. This new once-daily pill offers an alternative to…

The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in…