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News|Articles|July 16, 2026

FDA Approves Enlicitide, First Oral PCSK9 for High Cholesterol

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Key Takeaways

  • FDA authorization establishes enlicitide as the first oral PCSK9 inhibitor for LDL-C reduction, positioning it as a daily alternative to subcutaneous PCSK9 agents.
  • The approved population includes adults with hypercholesterolemia, encompassing heterozygous familial hypercholesterolemia, in combination with diet and exercise.
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In trials, the first oral PCSK9 inhibitor cut LDL cholesterol by up to 60%, which matched the efficacy of injectable PCSK9 therapies.

The FDA approved enlicitide (Lipfendra; Merck), the first oral PCSK9 inhibitor for lowering low-density lipoprotein cholesterol (LDL-C) in combination with diet and exercise, giving patients and prescribers a daily pill alternative to injectables. The pills are approved for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).

Enlicitide uses the same mechanism as injectable monoclonal antibodies like evolocumab (Repatha; Amgen) and alirocumab (Praluent; Regeneron and Sanofi) but delivered as a 20-mg tablet rather than a subcutaneous injection.

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