Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration has approved LEROCHOL™ (lerodalcibep-liga), a new cholesterol-lowering treatment developed by LIB Therapeutics, Inc., for adults with elevated low-density lipoprotein cholesterol (LDL-C) as an addition to diet and exercise. This approval marks a significant step in expanding treatment options for patients who struggle to reach LDL-C targets with existing therapies.
Dean J. Kereiakes, MD, FACC, MSCAI, Chairman of The Christ Hospital Heart and Vascular Institute and Professor of Medicine at the University of Cincinnati, stated that achieving and maintaining lower LDL-C targets remains a key challenge in lipid management. He noted that LEROCHOL was designed to overcome practical barriers to PCSK9 inhibitor use through once-monthly, self-administered dosing with convenient storage, making it a meaningful addition for patients requiring lifelong cholesterol management, particularly those with cardiovascular disease.
What is LEROCHOL
LEROCHOL is a third-generation PCSK9 inhibitor designed to help patients with high LDL-C, including those with heterozygous familial hypercholesterolemia (HeFH). PCSK9 inhibitors work by blocking the PCSK9 protein, which normally reduces the number of LDL receptors on liver cells. By inhibiting PCSK9, more LDL receptors remain available to clear LDL cholesterol from the bloodstream.
Unlike some earlier PCSK9 inhibitors, LEROCHOL is formulated for once-monthly self-administration as a small-volume subcutaneous injection. It also offers extended room-temperature stability (up to three months), which may improve convenience and adherence for patients.
The FDA approval covers adults with hypercholesterolemia, including those with:
- High LDL-C that persists despite diet and lifestyle changes
- Heterozygous familial hypercholesterolemia (HeFH), a genetic condition that leads to lifelong elevated cholesterol levels.
LEROCHOL is intended for use alongside diet and exercise.
Clinical Evidence and Benefits
The approval decision was based on data from the LIBerate Phase 3 clinical program, which included several global, placebo-controlled trials. Across the Phase 3 LIBerate clinical program, approximately 2,900 patients were enrolled, with around 2,400 patients continuing treatment through 72 weeks. The primary efficacy analyses submitted to the FDA were based on a pooled population of approximately 2,500 evaluable patients.
Patients at high cardiovascular risk showed sustained LDL-C reductions of 60% or more. Individuals with HeFH experienced at least a 50% reduction in LDL-C.
These results indicate that LEROCHOL delivers robust and durable LDL-C lowering and could help patients achieve more aggressive cholesterol goals set in current treatment guidelines.
Safety Profile
In clinical trials, lerodalcibep was generally well tolerated. Common adverse reactions included injection site reactions and mild respiratory or gastrointestinal symptoms, consistent with expectations for biologic therapies in this class.
Commenting on the approval, Evan Stein, MD, PhD, Founder, CEO, and Chief Scientific Officer of LIB Therapeutics, said the FDA decision validates the company’s mission to develop a more patient-friendly option for long-term LDL-C reduction. He added that LEROCHOL was designed to help patients, including those with cardiovascular disease and familial hypercholesterolemia, achieve and maintain lower LDL-C targets, and that the company looks forward to making the therapy available to patients in the coming months.
LIB Therapeutics expects LEROCHOL to become available in the United States in spring 2026. The company is also pursuing regulatory approvals in other regions, including the European Medicines Agency (EMA).
High LDL cholesterol is a major modifiable risk factor for cardiovascular disease, the leading cause of death globally. Despite the wide use of statins and other lipid-lowering agents, many patients do not meet LDL-C targets. LEROCHOL’s ease of use and strong LDL-C lowering may offer a valuable option for clinicians and patients seeking more effective long-term management.
References
U.S. Food and Drug Administration Approves LIB Therapeutics’ LEROCHOL™ (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol, 15 December 2025, https://libtherapeutics.com/news-and-events/us-food-and-drug-administration-approves-lib-therapeutics-lerochol-for-adults-with-elevated-ldl-cholesterol.html
Approval Letter of Lerochol, https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761427Orig1s000ltr.pdf
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients (LIBerate-VI), ClinicalTrials.gov ID NCT05004675, https://clinicaltrials.gov/study/NCT05004675
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction (LIBerate-OLE), ClinicalTrials.gov ID NCT04798430, https://clinicaltrials.gov/study/NCT04798430
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH, ClinicalTrials.gov ID NCT04034485, https://clinicaltrials.gov/study/NCT04034485