Enlicitide (Lipfendra)_Dosage, benefits & legal status
Also known as Lipfendra, MK-0616, enlicitide decanoate, enlicitide chloride
A daily tablet version of the cholesterol injections, absorbed at about 1% but potent enough to work.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Enlicitide (Lipfendra)?
Plain language first. The technical label stays, but it never stands alone.Overview
It does what the injected PCSK9 drugs evolocumab and alirocumab do, as a daily pill. On top of statins it cut LDL cholesterol by 56 to 59% more than placebo in two trials with 3,207 adults. The FDA approved it on 15 July 2026; whether it prevents heart attacks will not be known until about 2029.
Enlicitide is an eight-residue macrocyclic peptide from Merck that blocks PCSK9, the protein that destroys the liver's LDL receptors. It has three rings, one mirror-image residue and only two unmodified amino acids, and the tablet carries sodium caprate to help it through the gut wall; even so, about 1% of a dose is absorbed.
What it's used for
A prescription tablet, added to diet and exercise, to lower LDL cholesterol in adults with high cholesterol, including the inherited form.
How does Enlicitide (Lipfendra) work?
What it does in the body, and where.Enlicitide grips PCSK9 at the exact spot PCSK9 would use to grab an LDL receptor.
- 01The receptor problemThe liver pulls LDL out of the blood with LDL receptors. PCSK9 binds those receptors and drags them inside to be destroyed, so fewer are left to clear LDL.
- 02Blocking PCSK9A 10 mg or larger dose cuts free PCSK9 by more than 90% at its peak. More receptors recycle to the cell surface and LDL falls, as with the injected antibodies.
- 03Built to be swallowedMerck found the starting ring by screening a huge library of peptides, then reworked it into three rings built mostly from unnatural building blocks that resist gut enzymes. Sodium caprate in the tablet helps a little cross the gut wall; only about 1% is absorbed, and it is potent enough for that to work.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
High cholesterol on statins
FDA-approved- Human trialCORALreef Lipids, 2,909 adults: LDL down 57.1% against up 3.0% at week 24; the gap narrowed to 47.6 points by week 52.
- Human trialApoB fell 50.3 points and lipoprotein(a) 28.2 points against placebo; neither is a labelled claim.
- Human trialDeaths were 0.77% against 0.83%, and serious adverse events 9.9% against 12.0%.
Inherited high cholesterol
FDA-approved- Human trialCORALreef HeFH, 303 adults, most on high-dose statins and nearly two-thirds on ezetimibe: LDL down 58.2% against up 2.6% at week 24.
- Human trialDiarrhoea 7% against 2% and dizziness 9% against 4%.
Against other cholesterol pills
FDA-approved- Human trialCORALreef AddOn, 301 statin users over 8 weeks: LDL down 64.6% against 27.8% on ezetimibe, 6.3% on bempedoic acid and 36.5% on the two combined.
- No dataThese are falls from baseline over 8 weeks, not placebo-adjusted, and are not in the US label.
Heart attacks and strokes
Investigational- No dataCORALreef Outcomes has enrolled about 14,550 people; results are expected around 2029. Until then the benefit is inferred from LDL lowering.
'Up to 60%' comes from a post-hoc reanalysis or the inherited high cholesterol trial at week 52; the main trial's primary result was 55.8 points. The '65% drop' is the 8-week CORALreef AddOn change from baseline, not a placebo-adjusted figure. There is no 'CORALreef AddVantage' trial; the comparator study is CORALreef AddOn. The absorption enhancer is sodium caprate, not SNAC, the one in oral semaglutide. The 20 mg dose is the active peptide, equal to 22.21 mg of the decanoate salt; phase 2 used a chloride salt. Two half-lives circulate: about 14 hours governs daily dosing, about 244 hours is the slow terminal phase. Lipoprotein(a) lowering is a trial finding, not a labelled claim, and it has not yet been shown to prevent heart attacks. Approval was on 15 July 2026; many reports give the 16th or 17th.
The published record
Papers and trials about Enlicitide (Lipfendra)
63 papers tagged human · 9 not reviews or lab · 5 clinical trial publications
34 registered trials · 7 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Enlicitide (Lipfendra)
Evidence
FDA-approved
Category
Weight loss and metabolic
Common vial
Varies
Half-life
About 14 hours (effective)
How much, and do you cycle it?
The range, and whether you take breaks.20 mg once daily (label), once daily, in the morning on an empty stomach. Continuous, set by the prescription FDA label
Taken every day long term, alongside a statin and diet in the trials.
About 14 hours (effective)FDA label
The effective half-life that sets once-daily dosing. A slow terminal phase of about 244 hours follows. Peak levels come 30 to 60 minutes after a fasting dose and steady state in about 7 days. About 1% is absorbed, and the kidneys clear most of what reaches the blood.
Source: Lipfendra prescribing information section 12.3
You can compare this against the whole library to see where it sits.
What does it cost?
Typical dose and cost, in plain numbers.Enlicitide (Lipfendra) is not injected
It is taken by mouth (tablet). One 20 mg tablet each morning on an empty stomach, swallowed whole with water, black coffee or plain tea. Wait at least 30 minutes before other food or drink. Unlike oral semaglutide, other medicines can be taken at the same time. Taking it 30 minutes after a meal halved exposure. No dose change for kidney impairment, including dialysis. LDL can be rechecked from 4 weeks. The 20 mg is enlicitide itself, equal to 22.21 mg of the decanoate salt. A tablet, so the vial calculator does not apply.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Enlicitide (Lipfendra) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 25% charged residues, 75% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Pregnancy: the label says to stop once pregnancy is recognised, since blocking PCSK9 may harm a fetus by its mechanism
- Breastfeeding, where there are no human data
- Under 18, where it is not approved; a trial in children with inherited high cholesterol is recruiting
- Severe liver impairment (Child-Pugh C), not studied
Stop and get help
- Swelling of the face or throat, spreading hives or trouble breathing
- Severe or lasting diarrhoea with dizziness or fainting
Common effects
- Diarrhoea in 7% against 2% on placebo in the inherited high cholesterol trial
- Dizziness in 9% against 4% in the same trial
- In the 2,904-person main trial, any side effect 64% against 62% on placebo; stopping for side effects 3.1% against 4.1%
- Serious adverse events 9.9% against 12.0% on placebo over 52 weeks
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Enlicitide (Lipfendra) approved?
And where the numbers on this page come from.Yes. Enlicitide (Lipfendra) is FDA approved and available on prescription in the United States.
- Approval statusFDA-approved
- RouteBy mouth (tablet)
- Checked13 October 2026
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesLipfendra prescribing information (Merck, 7/2026)Lipfendra on DailyMedFDA approval letter, NDA 220848FDA multidisciplinary review, NDA 220848FDA press announcement (July 2026)Drugs@FDA, NDA 220848FDA GSRS substance record, enlicitide (UNII R7EZ772VG2)Navar AM et al., New England Journal of Medicine 2026;394:529-539 (CORALreef Lipids)Ballantyne CM et al., JAMA 2026;335(2) (CORALreef HeFH)ClinicalTrials.gov, CORALreef AddOn (NCT06450366)ClinicalTrials.gov, phase 2b (NCT05261126)Merck, Lipfendra price disclosure (July 2026)Merck, Lipfendra FDA approval (15 Jul 2026)
What has happened recently
FDA-approved on 15 July 2026 under NDA 220848 as a new molecular entity, as an adjunct to diet and exercise to lower LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. It was reviewed under the FDA Commissioner's National Priority Voucher pilot (voucher granted December 2025): the last part of the rolling application arrived on 22 June 2026 and approval came 23 days later. The label makes no claim about heart attacks or strokes. The FDA requires a trial in children with inherited high cholesterol. Merck's list price is $315 for 30 tablets. No approval outside the US was found as of October 2026, and no generic exists.
You can compare this against the whole library, or read how to check a seller.
What else is like Enlicitide (Lipfendra)?
Others in Taken without a needle, side by side.If you're weighing Enlicitide (Lipfendra), it's worth reading GB-115, Glandokort, and Gotratix in the same class.
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Guides for this compound
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- Semaglutide vs Tirzepatide vs Retatrutide
One receptor, two, or three. Mechanism, trial weight loss, side effects, and real cost.
Sources
- Lipfendra prescribing information (Merck, 7/2026)(2026)20 mg once daily fasting; sodium caprate in the tablet; effective half-life about 14 hours, terminal about 244; about 1% bioavailable. Diarrhoea 7% against 2% and dizziness 9% against 4% in the inherited high cholesterol trial.
- Lipfendra on DailyMed(2026)Same label as structured product labelling; no contraindications, no boxed warning, no warnings section.
- FDA approval letter, NDA 220848(2026)Approved 15 July 2026; paediatric study in heterozygous familial hypercholesterolaemia from age 6 required.
- FDA multidisciplinary review, NDA 220848(2026)Describes 'an 8-amino-acid macrocyclic peptide'; National Priority Voucher granted 19 December 2025; oral bioavailability about 1%.
- FDA press announcement (July 2026)(2026)First oral PCSK9 inhibitor; two trials in 3,207 adults with placebo-adjusted LDL reductions of 56% and 59% at 24 weeks.
- Drugs@FDA, NDA 220848(2026)Type 1 new molecular entity, priority review; enlicitide decanoate, equivalent to 20 mg base.
- FDA GSRS substance record, enlicitide (UNII R7EZ772VG2)(2026)CAS 2407527-14-2; C82H110FN14O15+, MW 1550.84. Chemical name gives the eight residues, two lactams and one ether ring.
- Navar AM et al., New England Journal of Medicine 2026;394:529-539 (CORALreef Lipids)(2026)2,909 adults on statins: LDL down 57.1% against up 3.0% at week 24, a 55.8-point difference; 47.6 points at week 52. Lipoprotein(a) down 28.2 points.
- Ballantyne CM et al., JAMA 2026;335(2) (CORALreef HeFH)(2026)303 adults with heterozygous familial hypercholesterolaemia: a 59.4-point LDL difference at week 24 and 61.5 at week 52.
- ClinicalTrials.gov, CORALreef AddOn (NCT06450366)(2026)301 statin users, 8 weeks: LDL down 64.6% on enlicitide against 27.8% on ezetimibe, 6.3% on bempedoic acid and 36.5% on both.
- ClinicalTrials.gov, phase 2b (NCT05261126)(2023)381 people on the chloride salt at 6 to 30 mg for 8 weeks: LDL down 40.0 to 59.7% against up 1.2% on placebo.
- Merck, Lipfendra price disclosure (July 2026)(2026)Wholesale acquisition cost $315.00 for a bottle of 30 tablets; a list price, not what patients pay.
- Merck, Lipfendra FDA approval (15 Jul 2026)(2026)Approval announcement; CORALreef Outcomes in more than 14,500 people is ongoing.
Beyond these, 87 records are indexed. Browse the records