Skip to main content
Print Save

Nexletol FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

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

Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.

Development timeline for Nexletol

DateArticle
Feb 21, 2020Approval FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol
May  5, 2019Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
Mar 13, 2019Esperion Announces Publication of Bempedoic Acid Study 1 Results in The New England Journal of Medicine

See also

Nexletol (bempedoic acid) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer