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Lerochol (LERODALCIBEP)
Lerodalcibep works by modulating a specific biological pathway to lower cholesterol levels.
At a glance
| Generic name | LERODALCIBEP |
|---|---|
| Sponsor | Lib Therapeutics, Inc. |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Lerodalcibep-liga is a recombinant fusion protein that binds PCSK9 with picomolar affinity. PCSK9 binds to low-density lipoprotein receptor (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, lerodalcibep-liga increases the number of LDLRs available to clear LDL-C from the blood, thereby lowering LDL-C levels. [see Clinical Pharmacology ( 12.3 )] .
Approved indications
- hypercholesterolemia
- heterozygous familial hypercholesterolemia (HeFH)
Common side effects
- Nasopharyngitis
- Injection site reactions
- Peripheral edema
- Diarrhea
- Nausea
Key clinical trials
- Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH (PHASE3)
- A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants (PHASE1)
- A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia (PHASE3)
- Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients (PHASE3)
- Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction (PHASE3)
- Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction (PHASE3)
- Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction (PHASE3)
- Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |