MK-0616 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

Macrocyclic peptide PCSK9 inhibitor compound ReferenceFilm-coatedtablet approved

Also known as: enlicitide, enlicitide decanoate, MK 0616

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Quick Facts

Reference Sizes

20 mg film-coated tablet

Storage

For the approved tablet product: store at 20°C to 25°C, with permitted excursions between 15°C and 30°C; store and dispense in the original tightly closed bottle with desiccant to protect from moisture.

Solubility

Slightly soluble in water, according to the FDA-approved product labeling for enlicitide decanoate.

Catalog Description

Enlicitide decanoate is a macrocyclic peptide PCSK9 inhibitor. By inhibiting PCSK9 binding to hepatic LDL receptors, it increases receptor availability and promotes clearance of circulating LDL cholesterol. MK-0616 was evaluated in phase 1 and phase 2 clinical studies and received U.S. FDA approval in July 2026 as Lipfendra, a once-daily oral tablet for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

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

Research Profile

Half-Life

Apparent terminal plasma half-life ranged from approximately 35 hours at 10 mg to approximately 130 hours at 300 mg after single oral doses in healthy participants under fasting conditions. These values are formulation- and dose-study specific and should not be generalized beyond the reported clinical studies.

Onset

In the approved labeling, maximum reduction of plasma free PCSK9 after single doses of at least 10 mg occurred at the enlicitide Tmax of approximately 0.5–1 hour. LDL-cholesterol efficacy in pivotal trials was assessed at week 24.

Administration Routes (Research)

oral

Reported Research Effects

Binds PCSK9 and inhibits PCSK9 interaction with the LDL receptor.
Increases hepatic LDL-receptor availability and lowers LDL cholesterol.
Single oral doses of at least 10 mg produced greater than 90% maximum reduction in plasma free PCSK9 in the FDA-approved labeling.
In a phase 2b study, placebo-adjusted LDL cholesterol reductions at week 8 were approximately 41.2%, 55.7%, 59.1%, and 60.9% with 6, 12, 18, and 30 mg once-daily regimens, respectively.
In phase 3 studies summarized by FDA, the 20 mg regimen produced average placebo-adjusted LDL cholesterol reductions of 56% at week 24 in adults with ASCVD or elevated cardiovascular risk and 59% in adults with heterozygous familial hypercholesterolemia.

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

Research Notes

Clinical reference regimens include 6, 12, 18, or 30 mg orally once daily for 8 weeks in a phase 2b study; phase 1 studies evaluated single oral doses from 10 to 300 mg and multiple once-daily dosing for 14 days. The approved U.S. product is a 20 mg enlicitide-equivalent film-coated tablet taken orally once daily on an empty stomach. Cardiovascular outcomes research remains separately tracked in the CORALreef Outcomes study.

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

Registry Identifiers

PubChem CID 167312471 for the MK-0616 cationic form; enlicitide decanoate UNII PSR59MCX5M; enlicitide decanoate molecular formula C92H129FN14O17; molecular weight 1722.12 g/mol; MK-0616 cationic form molecular formula C81H109FN15O15S2+; molecular weight approximately 1616.0 g/mol.

Source-Backed Observations

The active pharmaceutical ingredient in the approved tablet is enlicitide decanoate, providing 20 mg enlicitide equivalent to 22.21 mg enlicitide decanoate per tablet. Earlier clinical studies used MK-0616 salt/formulation terminology, including enlicitide chloride.

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

Sources

MK-0616 Compound Summary
https://pubchem.ncbi.nlm.nih.gov/compound/mk-0616 (accessed 2026-09-03)

LIPFENDRA (enlicitide) Prescribing Information and Drug Label
https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=100ec543-fbd0-44fc-b740-db9cdff39145 (accessed 2026-09-03)

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol (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)

A Phase 2b Study of MK-0616 in Adults With Hypercholesterolemia, NCT05261126
https://clinicaltrials.gov/study/NCT05261126 (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.