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Data · dataset · 2026

Enlicitide: First Approval

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<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Authorship and Conflict of interest</b> During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article.

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Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah A. Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest.

All authors contributed to this article and are responsible for its content.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </b>Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Enlicitide (LIPFENDRA<sup>®</sup>) is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor being developed by Merck Sharp & Dohme for the treatment of dyslipidaemias.

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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.</p><p dir="ltr">© Springer Nature Switzerland AG 2026</p>

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