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.
- Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation, PCSK9 inhibitor in development to overcome the limitations of current LDL cholesterol lowering treatments (including statins and ezetimibe) to achieve the lower LDL cholesterol targets in recently updated national and international guidelines to treat and prevent cardiovascular disease (CVD).
- Lerodalicibep is being developed as a small volume injection for once-monthly subcutaneous administration. It has long-ambient stability and does not require refrigeration by patients, providing a convenient alternative to approved PCSK9 inhibitors.
- A Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of lerodalcibep to reduce LDL cholesterol for the treatment of patients with atherosclerotic cardiovascular disease and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia.
Development timeline for lerodalcibep
Further information
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