Alirocumab
Approved · EMAAlso known as Praluent.
Recent clinical, regulatory, research and industry developments relating to this drug.
Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)
Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome.
Alirocumab lowers LDL cholesterol in hyperlipidaemia — High confidence reached
Evidence confidence
How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.
Confidence is high because multiple independent trials consistently report LDL cholesterol, with a narrow uncertainty band.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed… Show full indicationShow less
Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes2
Journals, researchers & institutions
- The New England journal of medicine2
- American heart journal1
- Cardiovascular drugs and therapy1
- Circulation journal : official journal of the Japanese Circulation Society1
- European heart journal1
- Journal of the American Heart Association1
- Pordy R5
- Baccara-Dinet MT4
- Lorenzato C4
- Farnier M3
- Chaudhari U2
- Civeira F2
- Ginsberg HN2
- Guyton JR2
- Academic Medical Center3
- Duke University Medical Center2
- Hospital Universitario Miguel Servet2
- Lipid Clinic2
- Center of Preventive Cardiology1
- Clinical Development1
- RxNorm (U.S. National Library of Medicine) — drug identity
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.