Lerodalcibep
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| Trade names | Lerochol |
| Other names | lerodalcibep-liga |
| AHFS/Drugs.com | lerochol |
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| Routes of administration | Subcutaneous |
| ATC code | |
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Lerodalcibep, sold under the brand name Lerochol, is a medication used for the treatment for high cholesterol.[1] It is a recombinant fusion protein that contains a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and human serum albumin.[1][2]
Lerodalcibep was approved for medical use in the United States in December 2025.[3][4][5]
Medical uses
Lerodalcibep is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.[1]
References
- ^ a b c d "Lerochol- lerodalcibep-liga injection, solution". DailyMed. 17 December 2025. Retrieved 28 December 2025.
- ^ Ballantyne CM, Norata GD (November 2025). "The evolving landscape of targets for lipid lowering: from molecular mechanisms to translational implications". European Heart Journal. 46 (44): 4737–4750. doi:10.1093/eurheartj/ehaf606. PMID 40911366.
- ^ "Letter to Dr. Stein about BLA Approval" (PDF). www.accessdata.fda.gov.
- ^ "Novel Drug Approvals for 2025". U.S. Food and Drug Administration. 23 December 2025. Retrieved 24 December 2025.
- ^ "U.S. Food and Drug Administration Approves LIB Therapeutics' Lerochol (lerodalcibep-liga) for Adults with Elevated LDL Cholesterol". LIB Therapeutics. 15 December 2025. Retrieved 24 December 2025 – via Business Wire.
External links
- Clinical trial number NCT04034485 for "Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH" at ClinicalTrials.gov
- Clinical trial number NCT04797247 for "Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction (LIBerate-CVD)" at ClinicalTrials.gov
- Clinical trial number NCT04806893 for "Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction (LIBerate-HR)" at ClinicalTrials.gov
- Clinical trial number NCT04797104 for "Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction (LIBerate-FH)" at ClinicalTrials.gov