FDA Approves Lerodalcibep for Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia

Lerodalcibep-liga (Lerochol; LIB Therapeutics Inc), a subcutaneous use injection, received FDA approval as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).¹

As a novel, third-generation PCSK9 inhibitor, lerodalcibep is designed to help patients achieve and maintain their LDL-C goals. It is self-administered as a once-monthly, small-volume subcutaneous injection and offers extended room-temperature stability for up to 3 months, aimed to allow patients flexibility in when and where they take their medication.¹

“[Lerodalcibep] was designed for patients who need lifelong treatment to achieve and maintain the new lower LDL-C goals, especially those with cardiovascular disease and the millions with inherited high cholesterol,” Evan Stein, MD, PhD, founder, CEO and chief scientific officer of LIB Therapeutics, said in a news release.¹

How Do Cardiovascular Disease and HeFH Impact LDL-C Levels?

Despite available lipid-lowering therapies, many patients with or at risk of cardiovascular disease (CVD) fail to meet LCL-C targets. This includes individuals with familial hyperchloremia (FH), which is an inherited defect in how the body recycles LDL. Individuals with FH are born with high LDL-C that continues to increase over time. According to the American Heart Association, 1 in about 200 adults has the FH genetic mutation, affecting about 1.3 million US adults and children; however, only 10% of individuals are aware they have the mutation.²

HeFH is the more common form of FH and is inherited from 1 parent. In severe cases, LCL-C levels can exceed 190 mg/dL, and without treatment, individuals may develop heart disease as early as 30 years of age. Early treatment for FH could greatly improve outcomes, especially for HeFH, where delays can be fatal in childhood. Lifestyle changes alone are insufficient, and medications are needed to lower LDL-C by at least 50%.²

How Data From the Phase 3 LIBerate Program Drove FDA Approval

The approval for lerodalcibep is based on data from the Phase 3 LIBerate Clinical Trial Program, which included 5 studies with over 2900 patients that experienced CVD or were at very high risk for CVD, including HeFH. Individuals included in the study received a once-monthly dosage of lerodalcibep for up to 52 weeks, and nearly 2400 patients continued treatment in the 72-week open-label extension trial.^1,3

The results from the clinical trial program demonstrated that patients receiving lerodalcibep achieved sustained LDL-C reductions of at least 60% in patients at high or very high CVD risk and at least 50% in those with HeFH. Further results found that the treatment was well tolerated, with no treatment-related adverse events reported in the long-term extension study.^1,3

Lerodalcibep is expected to be available in spring 2026.¹

“While PCSK9 inhibitors as a class deliver powerful cholesterol-lowering potential, [lerodalcibep] was designed to address the barriers that have limited their use, including ease-of-use features like a single small monthly injection self-administered at home with extended room-temperature stability for home storage and travel. For patients with CVD who require lifelong cholesterol management, [lerodalcibep] offers an important addition to our treatment options,” Dean J. Kereiakes, MD, FACC, MSCAI, chairman of the Christ Hospital Heart and Vascular Institute and professor of medicine at the University of Cincinnati, said in the news release.¹

REFERENCES

1. U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL^™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol. News release. Business Wire. December 15, 2025. Accessed December 15, 2025. https://www.businesswire.com/news/home/20251215907781/en/U.S.-Food-and-Drug-Administration-Approves-LIB-Therapeutics-LEROCHOL-lerodalcibep-liga-for-Adults-with-Elevated-LDL-Cholesterol

2. What is Familial Hypercholesterolemia? News release. American Heart Association. Updated February 19, 2024. Accessed December 15, 2025. https://www.heart.org/en/health-topics/cholesterol/genetic-conditions/familial-hypercholesterolemia-fh

3. Phase 3 LIBerate Program. LIB Therapeutics. Accessed December 15, 2025. https://libtherapeutics.com/ph3-liberate