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Leqvio (INCLISIRAN)
Leqvio works by binding to PCSK9, preventing it from breaking down LDL receptors.
Leqvio (Inclisiran) is a small molecule modality developed by Novartis that targets PCSK9 to treat atherosclerotic cardiovascular disease and familial hypercholesterolemia. It was FDA-approved in 2021 and remains a patented product with no generic manufacturers. Leqvio works by binding to PCSK9, preventing it from breaking down LDL receptors, and thereby reducing LDL cholesterol levels. Key safety considerations include potential liver enzyme elevations and injection site reactions. As a patented product, Leqvio is not yet available as a generic.
At a glance
| Generic name | INCLISIRAN |
|---|---|
| Sponsor | Novartis |
| Target | Proprotein convertase subtilisin/kexin type 9 |
| Modality | Oligonucleotide |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 863 |
Mechanism of action
Think of PCSK9 like a garbage truck that picks up LDL receptors from the surface of liver cells. When PCSK9 binds to these receptors, it takes them away, reducing the number of receptors available to remove LDL cholesterol from the blood. By binding to PCSK9, Leqvio prevents it from doing its job, allowing more LDL receptors to stay on the liver cells and remove more LDL cholesterol from the blood.
Approved indications
- Atherosclerotic cardiovascular disease
- Familial hypercholesterolemia - heterozygous
Common side effects
- Low density lipoprotein increased
- Myalgia
- Injection site pain
- Arthralgia
- Injection site rash
Key clinical trials
- Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (PHASE4)
- Real World Adherence of PCSK9 Targeted Therapy
- A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. (PHASE3)
- Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD (PHASE3)
- The Belgian REAL (BE.REAL) Registry
- Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (PHASE3)
- Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes (PHASE3)
- Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
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
- Novartis portfolio CI