enlicitide decanoate 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; proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor; lipid-lowering agent compound Reference needs_revision Best effort · source review pending

Also known as: enlicitide, MK-0616, MK 0616, LIPFENDRA

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Best-effort research profile: this record has not passed full two-source scientific verification. Descriptive fields, research protocols, storage/handling notes, and interaction guidance below are shown with their evidence labels, but calculator presets and exact dosing math remain hidden until the record is verified or reaches Community-Supported status.

Quick Facts

Reference Sizes

Not standardized / source review pending

Storage

For the labeled tablet product: store at 20°C to 25°C (68°F to 77°F), with permitted excursions between 15°C and 30°C (59°F and 86°F). Store and dispense in the original tightly closed bottle with desiccant to protect from moisture.

Solubility

Slightly soluble in water.

Best-Effort Research Profile

Enlicitide decanoate is the decanoate salt of enlicitide, a macrocyclic peptide that binds PCSK9 and inhibits its interaction with hepatic low-density lipoprotein receptors. This increases available LDL receptors and promotes LDL-C clearance. The compound was previously identified by the development code MK-0616 and is administered orally in tablet form.

Source review pending. This descriptive profile is shown from the available source material as a best-effort educational reference. It has not passed the full verification bar and is not a dosing instruction, medical claim, or treatment recommendation.

Research Profile

Half-Life

Effective half-life approximately 14 hours; terminal half-life approximately 244 hours.

Onset

Following oral administration, plasma Tmax is approximately 0.5–1 hour; maximum reduction in free plasma PCSK9 was observed at approximately 0.5–1 hour after single doses of 10 mg or greater.

Administration Routes (Research)

oral

Reported Research Effects

Inhibits binding of PCSK9 to hepatic LDL receptors.
Increases the number of LDL receptors available for LDL-C clearance.
Reduces circulating LDL-C and other atherogenic lipid parameters in clinical studies.

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

Research Notes

U.S. FDA approval of the oral enlicitide product Lipfendra was reported on July 17, 2026, for use as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. ClinicalTrials.gov records and peer-reviewed studies identify the compound as enlicitide decanoate or MK-0616. The recommended labeled tablet regimen is 20 mg enlicitide orally once daily; this is recorded here as regulatory reference information, not individualized medical guidance.

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

Registry Identifiers

FDA UNII: PSR59MCX5M; PubChem CID: 172866837; molecular formula: C92H129FN14O17; molecular weight: 1722.12 g/mol

Source-Backed Observations

The active pharmaceutical ingredient is described as a white to off-white powder that is slightly soluble in water. The labeled tablet contains 20 mg enlicitide, equivalent to 22.21 mg enlicitide decanoate.

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

Sources Under Review

LIPFENDRA (enlicitide) Prescribing Information
https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=100ec543-fbd0-44fc-b740-db9cdff39145&type=pdf (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)

Enlicitide Decanoate, FDA Global Substance Registration System
https://precision.fda.gov/ginas/app/ui/substances/PSR59MCX5M (accessed 2026-09-03)

Enlicitide Decanoate, PubChem Compound Summary, CID 172866837
https://pubchem.ncbi.nlm.nih.gov/compound/172866837 (accessed 2026-09-03)

Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial
https://pubmed.ncbi.nlm.nih.gov/42017875/ (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.