FDA Approves First Oral PCSK9 Inhibitor

Exam-focused facts from the 19 July 2026 current affairs briefing.

Key facts

The US Food and Drug Administration (FDA) approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, on July 16, 2026.
Lipfendra is a once-daily tablet for adults with high LDL cholesterol, including familial hypercholesterolemia.
In clinical trials, Lipfendra reduced LDL cholesterol by 56% in adults with heart disease or high risk, and by 59% in those with familial hypercholesterolemia.
Lipfendra also lowers lipoprotein(a) (Lp(a)) by approximately 25%, similar to injectable PCSK9 inhibitors.
Common side effects observed in the familial hypercholesterolemia trial included diarrhea (7% vs 2% placebo) and dizziness (9% vs 4% placebo).