Enlicitide approved as first oral PCSK9 inhibitor

The US Food and Drug Administration (FDA) has approved enlicitide, the first oral PCSK9 inhibitor designed to lower low-density lipoprotein (LDL) cholesterol. Approved on July 16, 2026, the medication provides an alternative for patients who wish to avoid the regular injections required by previous classes of PCSK9 inhibitors.

Clinical data from the CORALreef Lipids trial, a multinational, double-blind, randomized, placebo-controlled study, demonstrated that enlicitide significantly reduced LDL cholesterol. After 24 weeks, patients taking enlicitide saw a reduction of more than 57%, compared to a 3% reduction in the placebo group.

Currently, the FDA has cleared enlicitide as an add-on therapy to be used alongside statins when statins alone are insufficient to reach clinical targets. While the oral format may improve treatment adherence by removing the need for injections, researchers note that further studies are required to determine the efficacy of enlicitide as a standalone treatment for cardiovascular indications.