Enlicitide (Lipfendra)
FDA approved in July 2026 as the first oral once-daily PCSK9 inhibitor for high cholesterol.
What it is
Oral PCSK9 inhibitor for adults with hypercholesterolemia, taken once a day. It targets the large cardiovascular market currently served by injectable PCSK9 antibodies.
Why it matters to the stock. A pill that lowers LDL cholesterol would open a much larger patient pool than injectables, and it is Merck's main cardiovascular bet after Winrevair.
News
FDA approves Lipfendra (enlicitide), the first once-daily oral PCSK9 cholesterol medicine
The FDA approved Merck's Lipfendra (enlicitide) 20 mg tablets as an add-on to diet and exercise for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
Regulation