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.
Pivotal trial
The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Lipfendra
- The Oral PCSK9 Inhibitor Market Enters High-Growth Phase Owing to the Approval of Merck's LIPFENDRA and the Emergence of Oral PCSK9 Inhibitor Drugs, Including, AstraZeneca's AZD0780, Aqur's AQR-008, and Others | DelveInsight - Yahoo Finance
- Lipfendra pill aims to lower bad cholesterol for statin users - KOAT
- What To Know About Lipfendra, The New Cholesterol-Lowering Pill - MedShadow Foundation
- As FDA makes Lipfendra poster child of CNPV pilot, Merck charts long-term path for first PCSK9 pill - Fierce Pharma
- Lipfendra vs statins: How these cholesterol-lowering drugs compare - MedicalNewsToday