FDA approves Lipfendra as the first oral PCSK9 inhibitor for high cholesterol

The once-daily tablet provides a new oral option for reducing LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. The FDA has approved Lipfendra (enlicitide) as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. As the first oral therapy to inhibit PCSK9, Lipfendra expands treatment choice beyond the injectable PCSK9 therapies previously available.

Field	Content
Alert Type	Drug Approval
Drug Name	Lipfendra
Indication	Reduction of LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia
Therapy Area(s)	Cardiology
Geography	US (FDA)
What Changed	The FDA approved Lipfendra (enlicitide) on 16 July 2026 as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. It is the first orally administered drug approved to inhibit PCSK9.
Clinical Relevance	Provides a once-daily oral PCSK9 treatment option for adults requiring LDL-cholesterol reduction, expanding choice beyond injectable PCSK9 therapies.
Source Link	FDA approval notice.
Date	16 July 2026

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