Lipfendra (enlicitide) Research Reference

Catalog classification, reference sizes, lab math links, and source-backed data. Educational use only — not medical advice.

Researched for: PepTools vendor-neutral scientific reference catalog

PCSK9 inhibitor; oral macrocyclic peptide lipid-lowering agent compound Reference approved

Also known as: Enlicitide, Enlicitide decanoate, MK-0616, MK-0616 chloride

Quick Facts

Reference Sizes
20 mg film-coated tablets; bottle of 30 tablets
Components
Enlicitide + Enlicitide decanoate salt + Sodium caprate permeation enhancer
Storage
Store at 20°C to 25°C (68°F to 77°F); permitted excursions are 15°C to 30°C (59°F to 86°F). The labeled package is a bottle of 30 tablets with desiccant and child-resistant closure.
Solubility
Enlicitide decanoate is slightly soluble in water.

Blend Components

This entry is a multi-compound blend. Each component can be opened individually in the reconstitution calculator.

Component
Enlicitide
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Component
Enlicitide decanoate salt
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Component
Sodium caprate permeation enhancer
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Component amounts shown are arithmetic starters based on equal distribution. Edit values in the calculator before saving.

Catalog Description

Lipfendra tablets contain enlicitide decanoate, corresponding to 20 mg of enlicitide per tablet. Enlicitide binds plasma proprotein convertase subtilisin/kexin type 9 (PCSK9), preventing PCSK9 interaction with the low-density lipoprotein receptor and increasing receptor availability for LDL-C clearance. The product received U.S. FDA approval in July 2026 for use with diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

Catalog descriptions reflect research context only. Not a medical claim or treatment recommendation.

Research Profile

Half-Life
Effective half-life approximately 14 hours; terminal half-life approximately 244 hours at steady state.
Onset
Enlicitide reaches peak plasma concentration approximately 0.5–1 hour after oral dosing under labeled fasting conditions, with maximum free-PCSK9 reduction occurring around this interval. The LDL-C-lowering effect may be measured as early as 4 weeks after initiation; steady state is reached in approximately 7 days.
Administration Routes (Research)
Oral

Reported Research Effects

Reflects preclinical/research literature context only. Not a medical claim, dosing instruction, or treatment recommendation.

Research Notes

The labeled regimen is one 20 mg tablet orally once daily. The FDA label specifies administration on an empty stomach in the morning with water, black coffee, or plain tea, followed by a wait of at least 30 minutes before food or other beverages. In a phase 3 randomized trial in adults with heterozygous familial hypercholesterolemia receiving background lipid-lowering therapy, 20 mg once daily was administered for 52 weeks and significantly reduced LDL-C. A phase 2 placebo-controlled trial reported a placebo-adjusted LDL-C reduction of approximately 55.8 percentage points at week 24. Cardiovascular-outcomes evidence for enlicitide itself was not established by the approval materials cited here.

Supplementary research context only. Not medical advice or a treatment recommendation.

Registry Identifiers

Active enlicitide: PubChem CID 164933665; CAS 2407527-14-2; UNII R7EZ772VG2; molecular formula C82H110FN14O15+; molecular weight 1550.8 g/mol. Enlicitide decanoate in the marketed tablet: molecular formula C92H129FN14O17; molecular weight 1722.12 g/mol.

Source-Backed Observations

The marketed formulation is an oral film-coated tablet containing 20 mg enlicitide, equivalent to 22.21 mg enlicitide decanoate. Sodium caprate is included as an oral permeation enhancer. The tablet is described as white to off-white with grey specks, oval-shaped, and debossed with “119” and the corporate logo.

Reflects published research. Educational reference — not a recommendation for use.

Sources

LIPFENDRA (enlicitide) Prescribing Information
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=100ec543-fbd0-44fc-b740-db9cdff39145 (accessed 2026-09-03)
Enlicitide, PubChem Compound Summary CID 164933665
https://pubchem.ncbi.nlm.nih.gov/compound/Enlicitide (accessed 2026-09-03)
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial
https://jamanetwork.com/journals/jama/fullarticle/2841258 (accessed 2026-09-03)
A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide
https://doi.org/10.1056/NEJMoa2511002 (accessed 2026-09-03)

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Research Use Only. All content is for educational and research reference only. Not medical advice, a treatment recommendation, or guidance on human use. Compounds are not FDA-approved drugs unless specifically noted.

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