Lerodalcibep
| Clinical data | |
|---|---|
| Pronunciation | /ˌlɛroʊˈdælsɪbɛp/ LER-oh-DAL-sih-bep |
| Trade names | Lerochol |
| Other names | lerodalcibep-liga |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a626018 |
| License data |
|
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem CID | |
| DrugBank | |
| UNII | |
| KEGG | |
Lerodalcibep, sold under the brand name Lerochol, is a medication used for the treatment of hypercholesterolemia (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]
The most common side effects are injection site reactions.[3]
Lerodalcibep was approved for medical use in the United States in December 2025.[4][5]
Medical uses
[edit]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]
Society and culture
[edit]Legal status
[edit]Lerodalcibep was approved for medical use in the United States in December 2025.[6]
In July 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Lyrokaul, intended for the treatment of adults with hypercholesterolemia and mixed dyslipidemia.[3] The applicant for this medicinal product is LIB Therapeutics.[3]
Names
[edit]Lerodalcibep is the international nonproprietary name.[7]
Lerodalcibep is sold under the brand name Lerochol.[1]
References
[edit]- 1 2 3 4 5 "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.
- 1 2 3 "Lyrokaul EPAR". European Medicines Agency (EMA). 24 July 2026. Retrieved 10 September 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "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" (Press release). LIB Therapeutics. 15 December 2025. Retrieved 24 December 2025 – via Business Wire.
- ↑ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.
External links
[edit]- 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
