JUL 16 2026
Merck Sharp & Dohme LLC — Lipfendra (enlicitide)
for high cholesterol
FDA approves Lipfendra (enlicitide) as the first oral PCSK9 inhibitor for adults with high cholesterol or heterozygous familial hypercholesterolemia.
About
High cholesterol is the presence of high levels of cholesterol in the blood. Lipfendra (enlicitide) is an oral pill that blocks a liver protein called PCSK9, which controls how much cholesterol is cleared from the bloodstream. By inhibiting this protein, the drug may help lower the amount of harmful cholesterol circulating in the body.
Pivotal trial
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Lipfendra
- Health Beat: Clinical studies on Lipfendra pill show success in high-cholesterol patients - WFMZ.com
- New cholesterol pill Lipfendra gets FDA approval: 2 experts weigh in - AOL.ca
- Is Merck (MRK) A Bargain After FDA Approval For LIPFENDRA And HIV PrEP Expansion? - simplywall.st
- Merck (MRK) Could Be 4% Undervalued As LIPFENDRA Approval Tests Its Premium Valuation - finance.yahoo.com
- I’m a cardiologist. I’m not sure the new cholesterol drug enlicitide is a game-changer - STAT