LEQVIO (inclisiran sodium)
Leqvio helps patients with high cholesterol lower their low-density lipoprotein (LDL-C) levels in combination with diet and exercise. It treats adults with general hypercholesterolemia as well as adults and children 12 years and older with genetic forms of high cholesterol, such as heterozygous or homozygous familial hypercholesterolemia. This medication is used to improve cholesterol management by targeting specific proteins in the liver.
How LEQVIO Works
Leqvio works by using small interfering RNA to trigger the breakdown of messenger RNA for the PCSK9 protein within liver cells. This process increases the number of receptors on the cell surface that can capture and remove LDL cholesterol from the blood, effectively lowering circulating cholesterol levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-12-22
- Patent Cliff
- 2036
- Revenue
- $335M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
LEQVIO Approval History
What LEQVIO Treats
3 indicationsLEQVIO is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercholesterolemia
- Heterozygous Familial Hypercholesterolemia
- Homozygous Familial Hypercholesterolemia
LEQVIO 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.
LEQVIO 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 LEQVIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05192941 V-DIFFERENCE results posted | CKJX839A12402 2024-511263-28 | Ph 4 | completed | Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia |
| NCT06431763 | CKJX839A1DE02 | Ph 4 | completed | A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease. |
| NCT04765657 | CKJX839A12307 | Ph 3 | active not recruiting | Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C) |
| NCT06280976 ARTCAP | 23.0001 | Ph 4 | withdrawn | Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) |
| NCT06338293 EItoCVP | KY20240123-02 | Ph 4 | recruiting | Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques |
| NCT04666298 ORION-15 results posted | CKJX839A11201 | Ph 2 | completed | Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C |
| NCT03814187 ORION-8 results posted | MDCO-PCS-17-05 CKJX839A12306B, 2017-003092-55 | Ph 3 | completed | Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C |
| NCT03399370 ORION-10 results posted | MDCO-PCS-17-04 | Ph 3 | completed | Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol |
| NCT03400800 ORION-11 results posted | MDCO-PCS-17-08 | Ph 3 | completed | Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol |
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.
LEQVIO FDA Label Details
Indications & Usage
FDA Label (PDF)LEQVIO is indicated for the treatment of Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia.
LEQVIO Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LEQVIO
Revenue Insights
- • Q4-2025: $335M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 26 active patents
Trial Analysis
- • 9 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment