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Lerodalcibep FDA Approval Status

Last updated by Judith Stewart, BPharm on Feb 19, 2025.

FDA Approved: No
Generic name: lerodalcibep
Company: LIB Therapeutics Inc.
Treatment for: High Cholesterol

Lerodalcibep is third-generation PCSK9 inhibitor in development for the treatment of adults with elevated low-density lipoprotein (LDL) cholesterol.

Development timeline for lerodalcibep

DateArticle
Feb 10, 2025LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
Dec 16, 2024LIB Therapeutics Submits a Biologics License Application to FDA for Lerodalcibep for the Treatment of Adults with Elevated LDL-Cholesterol
Nov 19, 2024LIB Therapeutics Announce Positive Results from Lerodalcibep 72-Week Open-Label Extension Studies
Apr  8, 2024LIB Therapeutics Announces Positive Results from LIBerate-HR Study: A 52-Week, Placebo-Controlled Registration-Enabling Trial of Lerodalcibep
Aug 28, 2023LIB Therapeutics Announces Positive Results from the Phase 3 Long-term Efficacy and Safety of Lerodalcibep in Heterozygous Familial Hypercholesterolemia (LIBerate-HeFH) Trial

Further information

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