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FDA Medication Tracker

← All approvals · Heart & blood · 2026

Lipfendra (enlicitide decanoate)

The FDA approved Lipfendra (enlicitide decanoate) on July 15, 2026 to reduce low-density lipoprotein cholesterol.
Brand name
Lipfendra
Generic name
enlicitide decanoate
FDA approval date
July 15, 2026
Approved use (FDA wording)
To reduce low-density lipoprotein cholesterol
Company
Msd
Application
NDA220848
Dosage form / route
TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Heart & blood

Indications and usage, from the FDA label

LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LIPFENDRA is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in a…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.