FDA Approves First Oral PCSK9 Inhibitor - Takeaways - MDSpire

FDA Approves First Oral PCSK9 Inhibitor

Merck reported placebo-adjusted LDL-C reductions of 56% and 59% at week 24 in two phase 3 CORALreef trials supporting the approval.

  • By

  • Kathryn Wighton

  • July 16, 2026

  • 2 min

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  • 1

    The FDA has approved enlicitide (LIPFENDRA) as the first oral PCSK9 inhibitor for adults with hypercholesterolemia.

  • 2

    Enlicitide is indicated as an adjunct to diet and exercise for reducing low-density lipoprotein cholesterol.

  • 3

    The approval was based on results from the phase 3 CORALreef Lipids and CORALreef HeFH trials.

  • 4

    In these trials, enlicitide demonstrated significant reductions in LDL-C and other lipid parameters compared to placebo.

  • 5

    Adverse reactions were similar between enlicitide and placebo groups, with diarrhea and dizziness reported more frequently in enlicitide-treated patients.

Original Source(s)

FDA Approves First Oral PCSK9 Inhibitor

  • by Kathryn Wighton

  • July 16, 2026

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