Drug intelligence / Profile preview

lerodalcibep

Development stage
Approved
Lead developer
LIB Therapeutics
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

Lerodalcibep is a **novel anti-PCSK9 biologic** being developed by LIB Therapeutics as a once-monthly, small-volume **subcutaneous injection** for lowering low-density lipoprotein cholesterol in patients with **atherosclerotic cardiovascular disease, primary hyperlipidemia, and familial hypercholesterolemia**. It is an **adnectin-based recombinant fusion protein** in which an engineered PCSK9-binding adnectin domain is fused to **human serum albumin** to extend half-life, enabling monthly dosing. By binding circulating **proprotein convertase subtilisin/kexin type 9**, lerodalcibep prevents PCSK9-mediated degradation of LDL receptors, thereby increasing hepatic LDL receptor recycling and enhancing LDL-C clearance. Across the Phase 3 LIBerate program, monthly 300 mg dosing showed robust and sustained LDL-C reductions, including in high-risk cardiovascular populations and heterozygous familial hypercholesterolemia, with additional development in homozygous familial hypercholesterolemia and pediatric HeFH. The program has also been partnered with Hasten Biopharmaceuticals for Greater China, and a US BLA was reported as accepted by FDA in 2025.

Brand names
Lerochol
Other names
HST101HST-101HST 101lerodalcibep
02

Targets

PCSK9 (Proprotein convertase subtilisin/kexin type 9)

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