FDA

Lerochol approved for LDL-cholesterol reduction in hypercholesterolemia

December 25, 2025

Brand name: Lerochol

Generic name: lerodalcibep-liga

Manufacturer: LIB Therapeutics

Approval date: December 12, 2025

FDA approved Lerochol (lerodalcibep-liga), a third-generation proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, for SC use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Efficacy

Approval was based on data from the phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of >2,900 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and >2,400 patients continued in the 72-week open-label extension trial.

In clinical trials, Lerochol demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, CVD and ≥59% in those with HeFH who have more severe LDL-C elevations.

Safety

Lerochol was generally well tolerated across the LIBerate Clinical Trial Program, with no treatment-related serious adverse events reported in the long-term extension studies.

Common adverse reactions occurring in ≥1% of patients treated with Lerochol were injection site reactions, nasopharyngitis, diarrhea, nausea, and peripheral edema.

Recommended dose

The recommended dosage of Lerochol is 300 mg administered SC once monthly.

Sources:

US Food and Drug Administration approves LIB Therapeutics’ Lerochol™ (lerodalcibep-liga) for adults with elevated LDL cholesterol. [News release]. 2025. https://libtherapeutics.com/news-and-events/us-food-and-drug-administration-approves-lib-therapeutics-lerochol-for-adults-with-elevated-ldl-cholesterol.html

Lerochol (lerodalcibep-liga) [package insert]. LIB Therapeutics. https://www.lerochol.com/prescribing-information Revised December 2025. Accessed December 20, 2025.