Enlicitide
Enlicitide is an oral macrocyclic peptide PCSK9 inhibitor, formerly MK-0616. Lipfendra is the FDA-approved tablet product containing enlicitide.
At a glance
- Evidence stage
- Approved use
- Regulatory status
- FDA approved Lipfendra in July 2026 to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
- Research context
- Enlicitide is an oral macrocyclic peptide PCSK9 inhibitor, formerly MK-0616. Lipfendra is the FDA-approved tablet product containing enlicitide.
What this is
- Enlicitide is an oral macrocyclic peptide PCSK9 inhibitor, formerly MK-0616. Lipfendra is the FDA-approved tablet product containing enlicitide.
What this isn't
- A recommendation to use, prepare, combine, or administer a product
- Evidence that a related molecule or a differently formulated product has the same effects
Key terms
Enlicitide is an oral macrocyclic peptide PCSK9 inhibitor, formerly MK-0616. Lipfendra is the FDA-approved tablet product containing enlicitide.
PCSK9 promotes loss of LDL receptors from liver cells. Enlicitide blocks that interaction, allowing more receptors to remain available to remove LDL cholesterol from the circulation. This is a targeted lipid-lowering mechanism, distinct from appetite-hormone peptides. The FDA approval announcement describes the product as an adjunct to diet and exercise for the specified adult population.
Evidence limits
How to read the evidence
The older description of enlicitide as merely investigational is now outdated for its U.S. approved indication. Approval is product- and indication-specific: it does not extend to research material, unrelated cardiovascular claims, children, or use for weight loss. The trial's background lipid treatment and selected risk profile also matter when interpreting the size of the observed benefit.
Sources appraised 2026-10-28. Educational information; not medical advice. Study findings apply to the populations, preparations and outcomes described.
External sources and citations
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