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; orally bioavailable macrocyclic peptide compound ReferenceFilm-coatedtablet approved

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

Quick Facts

Reference Sizes
20 mg enlicitide film-coated tablet; bottle of 30 tablets
Components
Enlicitide decanoate active pharmaceutical ingredient; each tablet contains 20 mg enlicitide equivalent to 22.21 mg enlicitide decanoate + Sodium caprate + Microcrystalline cellulose + Lactose monohydrate + Croscarmellose sodium + Colloidal silicon dioxide + Magnesium stearate
Storage
Store tablets at 20°C to 25°C (68°F to 77°F), with permitted excursions between 15°C and 30°C. Keep in the original bottle tightly closed to protect from moisture; do not remove the desiccant.
Solubility
Enlicitide decanoate is described in the approved product labeling as a white to off-white powder that 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 decanoate active pharmaceutical ingredient; each tablet contains 20 mg enlicitide equivalent to 22.21 mg enlicitide decanoate
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Component
Sodium caprate
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Component
Microcrystalline cellulose
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Component
Lactose monohydrate
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Component
Croscarmellose sodium
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Component
Colloidal silicon dioxide
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Component
Magnesium stearate
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Component amounts shown are arithmetic starters based on equal distribution. Edit values in the calculator before saving.

Catalog Description

Enlicitide, formerly identified as MK-0616, is an orally bioavailable macrocyclic peptide PCSK9 inhibitor. The marketed U.S. formulation is enlicitide decanoate (Lipfendra), supplied as a 20 mg enlicitide film-coated tablet. It is indicated as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. Enlicitide binds PCSK9 and inhibits its interaction with the LDL receptor, supporting receptor recycling and hepatic LDL-cholesterol clearance.

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

Research Profile

Half-Life
In an early phase 1 study of single oral doses of MK-0616/enlicitide decanoate in fasted healthy participants, apparent terminal half-life ranged from approximately 35 hours at 10 mg to approximately 130 hours at 300 mg; values were dose-dependent and formulation- and study-specific.
Onset
The approved product labeling states that the LDL-cholesterol-lowering effect may be measured as early as 4 weeks after initiation. In phase 3 trials, the primary LDL-cholesterol assessment was at week 24.
Administration Routes (Research)
oral

Reported Research Effects

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

Research Notes

Clinical development used the code MK-0616 and included enlicitide chloride and enlicitide decanoate forms. Early phase 1 studies evaluated single oral doses of 10, 35, 100, 200, and 300 mg and multiple once-daily oral dosing at 10 or 20 mg under fasting conditions. Phase 3 CORALreef trials evaluated 20 mg once daily. The CORALreef Lipids trial reported a placebo-adjusted LDL-cholesterol difference of approximately -56 percentage points at week 24, while the CORALreef HeFH trial reported approximately -59 percentage points. Cardiovascular-outcome evidence remains dependent on the dedicated outcomes trial and should not be inferred solely from LDL-cholesterol reduction.

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

Registry Identifiers

Enlicitide decanoate CAS RN 2861205-06-1; FDA UNII PSR59MCX5M; enlicitide active-moiety FDA UNII R7EZ772VG2; enlicitide chloride CAS RN 2407527-16-4; enlicitide decanoate molecular formula C92H129FN14O17; molecular weight 1722.12 g/mol; enlicitide chloride molecular formula C82H110ClFN14O15; InChIKey for enlicitide decanoate ZMLCOVYFOZPADV-QQCDJELVSA-N.

Source-Backed Observations

The U.S. FDA approved Lipfendra (enlicitide) on July 15, 2026. The approved dosage form is a 20 mg oral film-coated tablet. FDA and WHO records distinguish the active moiety and salt forms, including enlicitide decanoate and enlicitide chloride.

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)
FDA Approves First Oral Therapy that Inhibits PCSK9 to Lower Bad Cholesterol in Adults with High Cholesterol
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower (accessed 2026-09-03)
Enlicitide decanoate substance record
https://precision.fda.gov/uniisearch/srs/unii/PSR59MCX5M (accessed 2026-09-03)
Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor
https://pmc.ncbi.nlm.nih.gov/articles/PMC10325562/ (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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