Metabolic · FDA Approved
Enlicitide
FDA-approved
01 · Overview
Enlicitide (enlicitide decanoate, formerly MK-0616) is an oral macrocyclic peptide that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), developed by Merck (PMID 37125593). By blocking PCSK9 from binding the LDL receptor on liver cells, it increases LDL receptor recycling and lowers LDL cholesterol (PMID 42604807).
It was approved by the FDA in July 2026 as Lipfendra, the first oral PCSK9 inhibitor, taken once daily with diet and exercise in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (PMID 42604807).
02 · Research summary & key findings
In a phase 2b trial, once-daily enlicitide lowered LDL cholesterol by 41 to 61 percent versus placebo at 8 weeks, with adverse event rates similar to placebo (PMID 36889610). In the phase 3 CORALreef Lipids trial in 2,909 adults with or at risk for atherosclerotic cardiovascular disease, LDL cholesterol fell 57.1 percent with enlicitide versus a 3.0 percent rise with placebo at 24 weeks, with no apparent difference in adverse events (PMID 41879224). Whether this LDL lowering reduces cardiovascular events is being tested in the ongoing CORALreef Outcomes trial (PMID 42604807).
03 · Regulatory status
Enlicitide has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Enlicitide is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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Enlicitide is prescribed for the conditions on its label, and it is not part of our intake. If you are working on metabolic health and weight, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Oral
References
- [1]Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616 J Am Coll Cardiol, 2023. PMID 36889610
- [2]Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor Circulation, 2023. PMID 37125593
- [3]A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide N Engl J Med, 2026. PMID 41879224
- [4]Enlicitide: The first oral PCSK9 inhibitor approved for treatment of hypercholesterolemia Drug Discov Ther, 2026. PMID 42604807
Primary literature
- PubMed: "Enlicitide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Enlicitide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Enlicitide"
Chemical structure, molecular properties, and bioactivity data.
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