What is Lipfendra, the first oral PCSK9 inhibitor approved by the FDA?

Lipfendra (enlicitide), approved by the FDA in July 2026, is the first oral PCSK9 inhibitor designed to lower LDL cholesterol in adults with hypercholesterolemia, including those with HeFH. Taken once daily, it reduced LDL-C by up to 59% in trials and may expand PCSK9 therapy access beyond injectables to primary care use.