For years, patients whose LDL cholesterol refused to budge on statins had one strong non-statin option, and it came as a routine injection.
Many turned it down. A new drug now offers the same class of effect in tablet form.
The FDA cleared enlicitide, sold by Merck as Lipfendra, on July 16, 2026. It is the first oral PCSK9 inhibitor and is taken as one 20 mg tablet a day, alongside diet and exercise, in adults with high cholesterol, including those with heterozygous familial hypercholesterolemia, an inherited form of the condition.
Approval was built on the Phase 3 CORALreef Lipids study, published in The New England Journal of Medicine on February 10, 2026. Researchers randomized 2,909 adults at 168 sites in 14 countries to either enlicitide or placebo for 52 weeks.
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At week 24, the pill cut LDL by about 57 percent, while placebo edged up 3 percent.
The adjusted difference between the two groups was 55.8 percentage points, and the drop held through one year of dosing.
Who the drug is aimed at
The label covers adults with high LDL who need more than a statin, including patients with statin intolerance, where side effects like muscle pain make higher doses hard to tolerate.
In CORALreef Lipids, more than 70 percent of enlicitide-treated participants hit an LDL below 70 mg/dL with at least a 50 percent drop from baseline. In the placebo group, 1.5 percent did.
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For readers unsure where their own numbers stand, general LDL targets shift with age and cardiovascular risk, and a doctor is the right person to interpret them.
What is still unknown
CORALreef Lipids measured LDL, not heart attacks or strokes. A separate cardiovascular outcomes trial, CORALreef Outcomes, has enrolled more than 14,500 participants to test whether the LDL drop translates into fewer events.
Safety in the year-long lipids trial tracked closely with placebo. About 3 percent of enlicitide participants stopped treatment, compared with 4 percent on placebo.
Anyone considering a switch from a statin, or adding a PCSK9 inhibitor, should discuss it with the clinician managing their cholesterol care.
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Lipfendra is available by prescription in the United States as a once-daily 20 mg tablet.
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This article is made and published by Mie Hermansen, who may have used AI in the preparation.