FDA News Release

First oral PCSK9 inhibitor provides an additional treatment option for adults with hypercholesterolemia

For Immediate Release: July 17, 2026

The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).

PCSK9 inhibitors have previously been available only as injectable therapies. Lipfendra is administered as a once-daily oral tablet and provides an additional treatment option for adults who require further LDL-C reduction despite existing therapies.…