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Alirocumab Injectable Product
Alirocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower low-density lipoprotein cholesterol.
Alirocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower low-density lipoprotein cholesterol. Used for Treatment of adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet and other lipid-lowering treatments, or alone if the only lipid-lowering treatment is statin therapy..
At a glance
| Generic name | Alirocumab Injectable Product |
|---|---|
| Also known as | Praluent |
| Sponsor | Wolfson Medical Center |
| Drug class | PCSK9 inhibitor |
| Target | PCSK9 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
By inhibiting PCSK9, alirocumab reduces the degradation of low-density lipoprotein receptors on the liver surface, leading to increased clearance of low-density lipoprotein cholesterol from the bloodstream. This results in a decrease in the levels of low-density lipoprotein cholesterol in the blood, which can help to reduce the risk of cardiovascular events.
Approved indications
- Treatment of adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet and other lipid-lowering treatments, or alone if the only lipid-lowering treatment is statin therapy.
Common side effects
- Injection site reactions
- Musculoskeletal pain
- Fatigue
Key clinical trials
- The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial (PHASE4)
- Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo (PHASE4)
- PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis (EARLY_PHASE1)
- Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab (PHASE4)
- Treatment of Severe Infection With Antihyperlipidemia Drug (PHASE2, PHASE3)
- Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) (PHASE3)
- Open Label Study of Long Term Safety Evaluation of Alirocumab (PHASE3)
- Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) (PHASE3)
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:
- Alirocumab Injectable Product CI brief — competitive landscape report
- Alirocumab Injectable Product updates RSS · CI watch RSS
- Wolfson Medical Center portfolio CI