BLAINJECTIONINJECTABLE
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
21
Data completeness
4/8 — Partial
PRALUENT (alirocumab) by Regeneron is pcsk9 inhibitors [moa]. Approved for pcsk9 inhibitor [epc]. First approved in 2015.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRALUENT (alirocumab) is a monoclonal antibody that inhibits PCSK9, a protein regulator of LDL cholesterol clearance. It is indicated for patients with hypercholesterolemia who require additional LDL-lowering therapy beyond statins. By blocking PCSK9, it increases hepatic uptake of LDL particles, delivering significant cholesterol reduction.
Peak
Product is at peak commercial maturity with moderate competitive pressure (30% intensity); team focus is on market defense and maintaining share against established competitors.
Mechanism of Action
PCSK9 Inhibitors
Pharmacologic Class:
PCSK9 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
Started Jun 2026
420 enrolled
Hypercholesterolemia
A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab
Started Apr 2026
5,995 enrolled
Cardiovascular DiseasesAtherosclerotic Cardiovascular DiseaseHypercholesterolemia, Familial
Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice
Started May 2025
124 enrolled
Atherosclerotic Cardiovascular Disease
Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)
Started Feb 2025
2,214 enrolled
Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Alirocumab in Patients with Sepsis
Started Jan 2023
50 enrolled
Sepsis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.