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Nexlizet FDA Approval History

Last updated by Judith Stewart, BPharm on March 26, 2024.

FDA Approved: Yes (First approved February 26, 2020)
Brand name: Nexlizet
Generic name: bempedoic acid and ezetimibe
Dosage form: Tablets
Company: Esperion Therapeutics
Treatment for: High Cholesterol, Familial Heterozygous

Nexlizet (bempedoic acid and ezetimibe) is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor combination used for the treatment of primary hyperlipidemia.

Development timeline for Nexlizet

DateArticle
Mar 22, 2024Approval U.S. FDA Approves Broad New Labels for Nexletol and Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use
Dec 13, 2023Approval U.S. FDA Updates LDL-C Lowering Indication for Esperion’s Nexletol (bempedoic acid) Tablet and Nexlizet (bempedoic acid and ezetimibe) Tablet
Feb 26, 2020Approval FDA Approves Nexlizet (bempedoic acid and ezetimibe) 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

Nexlizet (bempedoic acid and ezetimibe) Consumer information

Further information

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