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Enlicitide

All articles tagged with #enlicitide

Merck's Lipfendra Becomes the First Oral PCSK9 Inhibitor to Lower LDL-C
business23 days ago

Merck's Lipfendra Becomes the First Oral PCSK9 Inhibitor to Lower LDL-C

The FDA has approved Lipfendra (enlicitide), Merck’s oral PCSK9 inhibitor, to lower LDL-C in patients not adequately controlled on statins. As the first oral option in this class, enlicitide is a macrocyclic peptide designed to disrupt PCSK9-LDL receptor interactions and is produced via a biocatalytic process using 13 engineered enzymes. Because it’s a pill rather than an injectable antibody, it could be prescribed by general practitioners, expanding access, though cost and adherence remain concerns; patients must fast for 30 minutes after dosing for full absorption.

A daily pill that slashes LDL could change how we fight heart disease
future-perfect1 month ago

A daily pill that slashes LDL could change how we fight heart disease

FDA-approved enlicitide is an oral pill that lowers LDL cholesterol by about 60%, offering a needle-free alternative to injections and statins for those who can’t tolerate them; the drug’s development builds on PCSK9 genetics, and while LDL reductions look promising, hard outcomes like deaths will take years to prove, and cost and access—alongside the potential of gene editing and other therapies—will shape how broadly it helps curb heart disease.

Merck’s Lipfendra gains FDA nod as first oral PCSK9 inhibitor
health1 month ago

Merck’s Lipfendra gains FDA nod as first oral PCSK9 inhibitor

Merck’s cholesterol pill Lipfendra (enlicitide) was approved by the FDA, becoming the first oral PCSK9 inhibitor on the market and offering an alternative to injectable cholesterol drugs. The decision was based on two late‑stage trials showing significant LDL‑C reductions across a broad patient group, including those with familial hypercholesterolemia and statin users. The drug could help Merck diversify beyond Keytruda, with analysts forecasting potential tens of billions in peak sales amid competition from injectable PCSK9 drugs like Repatha and Praluent.

Oral PCSK9 Pill Cuts LDL Cholesterol by Up to 60% in Phase 3 Trial
health5 months ago

Oral PCSK9 Pill Cuts LDL Cholesterol by Up to 60% in Phase 3 Trial

A phase 3 trial of the daily oral PCSK9 inhibitor enlicitide showed LDL cholesterol falls by about 60% in 2,909 patients with atherosclerosis or high cardiovascular risk, many already on statins. The pill also reduced non-HDL cholesterol, apolipoprotein B, and lipoprotein(a), with effects lasting one year. If FDA approves, enlicitide could offer an oral alternative to injectable PCSK9 therapies and improve adherence, though a separate study is needed to confirm whether these LDL reductions translate into fewer heart attacks and strokes. The trial was Merck-funded and ongoing work aims to determine cardiovascular event outcomes.

Merck's PCSK9 Pill Shows Promise in Lowering Cholesterol to Injectable Levels
health9 months ago

Merck's PCSK9 Pill Shows Promise in Lowering Cholesterol to Injectable Levels

Merck has developed a new pill called enlicitide that significantly reduces LDL cholesterol levels by blocking the PCSK9 protein, showing promising results in clinical trials with a 20% reduction in heart attack and stroke rates among high-risk patients, and offering a potentially more affordable alternative to existing injectable treatments.