LEROCHOL (lerodalcibep-liga) · LIB THERAPEUTICS, INC.
LEROCHOL (lerodalcibep-liga) is a PCSK9 inhibitor indicated for the reduction of low-density lipoprotein cholesterol (LDL-C) in adult patients. It is used as an adjunct to diet and exercise in individuals with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). The medication provides a therapeutic option for managing elevated cholesterol levels in these specific patient populations.
How LEROCHOL Works
Lerodalcibep-liga is a recombinant fusion protein that binds to proprotein convertase subtilisin kexin type 9 (PCSK9) with high affinity. PCSK9 typically binds to low-density lipoprotein receptors (LDLR) on the surface of liver cells to promote their degradation. By inhibiting this binding, the drug increases the density of LDLRs available to clear LDL-C from the blood, thereby lowering cholesterol levels.
Details
- Status
- Prescription
- First Approved
- 2025-12-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LEROCHOL Approval History
What LEROCHOL Treats
2 indicationsLEROCHOL is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercholesterolemia
- Heterozygous Familial Hypercholesterolemia
LEROCHOL Target & Pathway
ProTarget
A protein that promotes degradation of LDL receptors, reducing the liver's ability to clear LDL cholesterol. Blocking PCSK9 increases LDL receptor availability, dramatically lowering LDL cholesterol levels beyond what statins achieve.
LEROCHOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LEROCHOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEROCHOL FDA Label Details
Indications & Usage
LEROCHOL TM 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 (HeFH). LEROCHOL is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Track LEROCHOL with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.