Lerodalcibep

Lerodalcibep

Clinical data
Trade names	Lerochol
Other names	lerodalcibep-liga
AHFS/Drugs.com	lerochol
License data	US  DailyMed:  Lerodalcibep
Routes of administration	Subcutaneous
ATC code	C10AX19 ( WHO )
Legal status
Legal status	US: ℞-only [1]
Identifiers
CAS Number	2250073-78-8
PubChem CID	505794687
DrugBank	DB19071
UNII	1PHP3QG5PZ
KEGG	D13095

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

1. "Lerochol- lerodalcibep-liga injection, solution". DailyMed. 17 December 2025. Retrieved 28 December 2025.
2. 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.
3. "Letter to Dr. Stein about BLA Approval" (PDF). www.accessdata.fda.gov.
4. "Novel Drug Approvals for 2025". U.S. Food and Drug Administration. 23 December 2025. Retrieved 24 December 2025.
5. "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