U.S. Food and Drug Administration approved Lipfendra (enlicitide) to lower low-density lipoprotein (LDL) cholesterol in adults

U.S. Food and Drug Administration approved Lipfendra (enlicitide) to lower low-density lipoprotein (LDL) cholesterol in adults

¨     U.S. Food and Drug Administration (FDA) approved Lipfendra (enlicitide) on 16 July 2026 to lower low-density lipoprotein (LDL) cholesterol in adults.

¨     It is the first FDA-approved oral PCSK9 inhibitor.

¨     Lipfendra is administered as a 20-mg tablet taken once daily.

¨     PCSK9 inhibitors are lipid-lowering medicines that block the PCSK9 pathway, increasing the number of LDL receptors that remove LDL cholesterol from the bloodstream.

¨     The drug is approved as an adjunct to diet and exercise for adults with hypercholesterolaemia, including those with heterozygous familial hypercholesterolaemia (HeFH).

¨     It provides an oral alternative to existing injectable PCSK9 inhibitors used for cholesterol management.

¨     The approval was based on two Phase 3 clinical trials—CORALreef Lipids and CORALreef HeFH—involving 3,207 adults.

¨     In the CORALreef Lipids trial, Lipfendra reduced LDL-C by an average of 56% compared with placebo at 24 weeks.

¨     A post-hoc analysis reported a 60% reduction in LDL-C after excluding certain baseline values.

¨     In the CORALreef HeFH trial, diarrhoea occurred in 7% of patients receiving Lipfendra compared with 2% receiving placebo, while dizziness occurred in 9% and 4%, respectively.

¨     Other oral cholesterol-lowering therapies include bempedoic acid (Nexletol) and bempedoic acid with ezetimibe (Nexlizet), which received expanded FDA labels on 22 March 2024.