First oral PCSK9 inhibitor approved in the USA

07 Aug 2026
Cholesterol
07 Aug 2026

The FDA recently approved enclicitide as a treatment option for patients with high LDL cholesterol (LDL-C) levels. Enclicitide is the first oral formulation of a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, which were previously only available in injectable forms (inclisiran is available in SA).

PCSK9 inhibitors are indicated in addition to lifestyle modifications and statins for patients unable to achieve LDL targets, including those with heterozygous familial hypercholesterolemia. Two placebo-controlled trials showed an average LDL-C reduction of 56% and 59% respectively after 24 weeks.

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