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LEQVIO
LEQVIO (inclisiran) reduces LDL cholesterol by inhibiting PCSK9 protein synthesis through RNA interference, allowing more LDL receptors to remain on liver cells.
LEQVIO (inclisiran) reduces LDL cholesterol by inhibiting PCSK9 protein synthesis through RNA interference, allowing more LDL receptors to remain on liver cells. Used for Heterozygous familial hypercholesterolemia (HeFH), Homozygous familial hypercholesterolemia (HoFH), Established cardiovascular disease with elevated LDL-C despite statin therapy.
At a glance
| Generic name | LEQVIO |
|---|---|
| Also known as | inclisiran |
| Sponsor | University of Louisville |
| Drug class | PCSK9 inhibitor (siRNA) |
| Target | PCSK9 mRNA |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Inclisiran is a small interfering RNA (siRNA) that targets PCSK9 mRNA, preventing the production of proprotein convertase subtilisin/kexin type 9 (PCSK9). By reducing PCSK9 levels, more LDL receptors remain available on hepatocytes to clear LDL cholesterol from the bloodstream. This results in significant reductions in LDL-C levels, particularly in patients with familial hypercholesterolemia or those already on statin therapy.
Approved indications
- Heterozygous familial hypercholesterolemia (HeFH)
- Homozygous familial hypercholesterolemia (HoFH)
- Established cardiovascular disease with elevated LDL-C despite statin therapy
Common side effects
- Injection site reactions
- Influenza-like illness
- Upper respiratory tract infection
Key clinical trials
- Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
- A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia (PHASE2)
- Specified Drug-use Survey of Leqvio for s.c. Injection.
- Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
- A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
- VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease (PHASE4)
- The Prevent Coronary Artery Disease Trial (PHASE3)
- Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) (PHASE4)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LEQVIO CI brief — competitive landscape report
- LEQVIO updates RSS · CI watch RSS
- University of Louisville portfolio CI