Nexletol FDA Approval History
Last updated by Judith Stewart, BPharm on March 26, 2024.
FDA Approved: Yes (First approved February 21, 2020)
Brand name: Nexletol
Generic name: bempedoic acid
Dosage form: Tablets
Company: Esperion Therapeutics, Inc.
Treatment for: High Cholesterol, Familial Heterozygous, Cardiovascular Risk Reduction
Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor used for cardiovascular risk reduction and the treatment of primary hyperlipidemia.
- Nexletol is indicated:
- to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD.
- as an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
Development timeline for Nexletol
Further information
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