FDA approves Lipfendra, first oral PCSK9 inhibitor pill for high cholesterol in adults; reduces bad LDL cholesterol by 56-59% in trials, offers alternative to injectable therapies

FDA approves Lipfendra, first oral PCSK9 inhibitor pill for high cholesterol in adults; reduces bad LDL cholesterol by 56-59% in trials, offers alternative to injectable therapies - July 17, 2026

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

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 famil...