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Praluent (Alirocumab)
Alirocumab is a monoclonal antibody that binds to and inhibits PCSK9, a protein that degrades LDL receptors, thereby increasing LDL receptor availability and lowering blood LDL cholesterol.
Alirocumab is a monoclonal antibody that binds to and inhibits PCSK9, a protein that degrades LDL receptors, thereby increasing LDL receptor availability and lowering blood LDL cholesterol. Used for Hypercholesterolemia (heterozygous familial and non-familial) in patients not adequately controlled by statins, Homozygous familial hypercholesterolemia, Established cardiovascular disease (secondary prevention).
At a glance
| Generic name | Praluent (Alirocumab) |
|---|---|
| Sponsor | Federico II University |
| Drug class | PCSK9 inhibitor (monoclonal antibody) |
| Target | PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
PCSK9 normally binds to LDL receptors on hepatocytes and promotes their degradation, reducing the liver's ability to clear LDL cholesterol from the blood. By blocking PCSK9, alirocumab prevents this degradation, allowing more LDL receptors to remain on the cell surface and increasing LDL cholesterol uptake from circulation. This results in significant reductions in plasma LDL cholesterol levels.
Approved indications
- Hypercholesterolemia (heterozygous familial and non-familial) in patients not adequately controlled by statins
- Homozygous familial hypercholesterolemia
- Established cardiovascular disease (secondary prevention)
Common side effects
- Injection site reactions
- Nasopharyngitis
- Influenza
- Myalgia
- Headache
Key clinical trials
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma (EARLY_PHASE1)
- A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia (PHASE2)
- Cardiac Allograft Vasculopathy Inhibition With Alirocumab (PHASE2)
- TOP 2301: Neoadjuvant Chemo for NSCLC (PHASE2)
- Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy
- Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction (PHASE4)
- PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung (PHASE2)
- Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
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:
- Praluent (Alirocumab) CI brief — competitive landscape report
- Praluent (Alirocumab) updates RSS · CI watch RSS
- Federico II University portfolio CI