Lipfendra (enlicitide decanoate) approved, the first oral PCSK9 inhibitor to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH) (Jul 16 2026).
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Key facts
FDA decision date2026-07-16
OutcomeApproved
Drug / candidateLipfendra (enlicitide decanoate, MK-0616)
Was Lipfendra (enlicitide decanoate, MK-0616) approved by the FDA?
Yes. The FDA approved the application for Lipfendra (enlicitide decanoate, MK-0616) on July 16, 2026. The primary source is linked on this page.
Which company is behind Lipfendra (enlicitide decanoate, MK-0616)?
Lipfendra (enlicitide decanoate, MK-0616) is a Merck & Co. (Merck Sharp & Dohme LLC) (MRK) program. The FDA decision came on July 16, 2026; the company's own announcement is linked on this page.
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