Key result
FDA approves oral PCSK9 inhibitor enlicitide to lower LDL-C in adults with hypercholesterolaemia.
Summarizes the development milestones leading to the first US approval of enlicitide, a PCSK9 inhibitor for reducing LDL-C in adults with hypercholesterolaemia.
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Enlicitide approval expands PCSK9 inhibitor options for hypercholesterolemia; leaves open comparative effectiveness and outcomes data.
Enlicitide (LIPFENDRA ® ) is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor being developed by Merck Sharp & Dohme for the treatment of dyslipidaemias. On 16 July 2026, enlicitide received its first approval in the USA where it is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH). This article summarizes the milestones in the development of enlicitide leading to this first approval for hypercholesterolaemia.
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Hannah A. Blair (2026) conducted a review in Hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH). Enlicitide was evaluated on Low-density lipoprotein cholesterol (LDL-C) reduction.
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