{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T12:46:50Z","timestamp":1792154810161,"version":"4.4.0"},"reference-count":52,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T00:00:00Z","timestamp":1791936000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>This article describes pharmacology, pharmacokinetics, safety, and efficacy data of enlicitide, the first Food and Drug Administration (FDA)-approved oral proprotein convertase subtilisin\/kexin type 9 inhibitor (PCSK9i).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources:<\/jats:title>\n                    <jats:p>PubMed, Embase, Web of Science, and Cochrane were searched through July 17, 2026.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study selection and data extraction:<\/jats:title>\n                    <jats:p>Clinical trials published in English were included. Relevant information from the methodology and results was extracted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data synthesis:<\/jats:title>\n                    <jats:p>Enlicitide received FDA approval on July 16, 2026, based on results from phase 2 and 3 trials showing a 57.1% to 64.6% reduction in low-density lipoprotein-cholesterol (LDL-C) and reduced other atherogenic lipid particles at 24\u2009weeks in patients with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia, while maintaining a favorable adverse effect profile. Enlicitide represents the fifth FDA-approved agent targeting PCSK9, having similar efficacy to other agents in class while having a novel macrocyclic peptide formulation with permeation enhancers, allowing for oral administration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:<\/jats:title>\n                    <jats:p>As PCSK9is continue to be at the forefront of dyslipidemia guidelines, the approval of an oral agent is paramount in ensuring patient access. Enlicitide mirrors LDL-C lowering compared with existing PCSK9is and surpasses LDL-C lowering compared with non-statin options such as bempedoic acid and ezetimibe. Confirmation of cardiovascular outcomes data with enlicitide will solidify its role in reducing atherosclerotic cardiovascular disease risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Enlicitide significantly lowered LDL-C similar to existing PCSK9is with few adverse effects. The oral formulation provides an essential option for LDL-C lowering, especially in patients adverse to injections.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280261494015","type":"journal-article","created":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T07:37:13Z","timestamp":1791963433000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Enlicitide: The First Oral PCSK9i for Lowering Low-Density Lipoprotein Cholesterol"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4934-1899","authenticated-orcid":false,"given":"Rachel C.","family":"Lucas","sequence":"first","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, Binghamton University, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5523-0781","authenticated-orcid":false,"given":"Mia E.","family":"Lussier","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, Binghamton University, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azadeh","family":"Nasuhidehnavi","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences, Department of Pharmaceutical Sciences, Binghamton University, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8624-533X","authenticated-orcid":false,"given":"Taylor M.","family":"Clark","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Pharmaceutical Sciences, Department of Pharmacy Practice, Binghamton University, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,14]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000001423"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.03.019"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.3608"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2014.09.007"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1615664"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1801174"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2514428"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.118.011246"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2017.3451"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.122.063372"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/ddr.21832"},{"key":"e_1_3_3_13_2","unstructured":"Lipfendra (Enlicitide) [Package Insert]. 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