PRALUENT (alirocumab)
Praluent (alirocumab) is a PCSK9 inhibitor indicated to reduce the risk of major adverse cardiovascular events, including myocardial infarction and stroke, in adults at increased risk. It is also used as an adjunct to diet and exercise to lower low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia or homozygous familial hypercholesterolemia. Furthermore, the treatment is approved for adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.
How PRALUENT Works
Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). Under normal physiological conditions, PCSK9 binds to low-density lipoprotein receptors (LDLR) on the surface of liver cells to promote their degradation. By inhibiting the binding of PCSK9 to these receptors, alirocumab increases the number of available LDLRs to clear LDL from the blood, thereby lowering LDL-C levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-07-24
- Patent Cliff
- 2028
- Revenue
- $146M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PRALUENT Approval History
What PRALUENT Treats
4 indicationsPRALUENT is approved for 4 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major adverse cardiovascular events risk reduction in adults
- Hypercholesterolemia in adults
- Heterozygous familial hypercholesterolemia in adults and pediatric patients (8 years and older)
- Homozygous familial hypercholesterolemia in adults
PRALUENT Target & Pathway
ProTarget
A protein that promotes degradation of LDL receptors, reducing the liver's ability to clear LDL cholesterol. Blocking PCSK9 increases LDL receptor availability, dramatically lowering LDL cholesterol levels beyond what statins achieve.
PRALUENT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PRALUENT
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
53 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07581808 PCSK9-DUO | UKC-PCSK9-DUO | Ph 4 | not yet recruiting | Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention |
| NCT04781322 | 10000036 000036-AA | Ph 1 | recruiting | Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers |
| NCT03537742 CAVIAR | IRB-45975 4R33HL139929 | Ph 2 | completed | Cardiac Allograft Vasculopathy Inhibition With Alirocumab |
| NCT07477704 | R727-CL-2553 | Ph 2 | not yet recruiting | A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia |
| NCT06385262 | Pro00114645 | Ph 2 | suspended | TOP 2301: Neoadjuvant Chemo for NSCLC |
| NCT05292404 | ShanghaiTRH-HL2022 | Ph 4 | recruiting | Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction |
| NCT03207945 EPIC-HIV | 17-22800 | Ph 3 | completed | Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study) |
| NCT05001984 TOPICAL-MRI | TOPICAL-MRI MOST 110-2314-B-182A-072 | Ph 2 | active not recruiting | Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis |
| NCT05469347 PALMS | STUDY00004119 | Ph 1 | completed | Alirocumab in Patients with Sepsis |
| NCT04189484 results posted | SCR-007 | Ph 1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors |
| NCT06083961 | PCSK9_001 | Ph 4 | not yet recruiting | The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile |
| NCT02959047 | 19404 | Ph 4 | completed | A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease |
| NCT04790513 LIBerate-H2H | LIB003-011 | Ph 3 | completed | Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients |
| NCT03344692 EUTERPE | RC16_0406 | Ph 3 | completed | Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes |
| NCT03004001 | VA16-029 | Ph 2 | terminated | Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome |
| NCT05465278 ARCHITECT | ARCHITECT | Ph 4 | completed | Alirocumab and Plaque Burden In Familial Hypercholesterolaemia |
| NCT03718286 EPIC STEMI | EPIC.STEMI.2018 | Ph 2 | completed | Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI |
| NCT03067844 PACMAN-AMI | 2016-01382 | Ph 3 | completed | Vascular Effects of Alirocumab in Acute MI-Patients |
| NCT03156621 ODYSSEY HoFH results posted | R727-CL-1628 2017-000351-95 | Ph 3 | completed | Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) |
| NCT03694197 results posted | R727-CL-1609 2018-002810-11 | Ph 4 | terminated | Long Term Safety Study of PRALUENT |
| NCT01576484 results posted | R727-CL-1032 | Ph 2 | completed | Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) |
| NCT01709513 results posted | R727-CL-1119 | Ph 3 | completed | Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) |
| NCT01604824 results posted | R727-CL-1018 | Ph 2 | completed | A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene |
| NCT02326220 ODYSSEY ESCAPE results posted | R727-CL-1216 | Ph 3 | completed | Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy |
| NCT01730053 results posted | R727-CL-1118 | Ph 3 | completed | Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II) |
| NCT02715726 ODYSSEY EAST results posted | EFC13889 U1111-1150-8859 | Ph 3 | completed | Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia |
| NCT02938949 results posted | HM20008008 | Ph 4 | completed | Alirocumab in Patients With Acute Myocardial Infarction |
| NCT03750760 EARLY | 18HH4627 2018-002429-49 | Ph 4 | withdrawn | Early Alirocumab to Reduce LDL-C in Myocardial Infarction |
| NCT01663402 results posted | EFC11570 2011-005698-21, U1111-1127-4323 | Ph 3 | completed | ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab |
| NCT02584504 ODYSSEY-NIPPON results posted | EFC14305 U1111-1170-7697 | Ph 3 | completed | Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin |
| NCT03014830 | 201612021 | Ph 1 | completed | Alirocumab and Reverse Cholesterol Transport |
| NCT02023879 results posted | EFC13786 2013-002659-14, U1111-1146-3517 | Ph 3 | completed | Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) |
| NCT01954394 ODYSSEY OLE results posted | LTS13463 2013-002572-40, U1111-1143-3810 | Ph 3 | completed | Open Label Study of Long Term Safety Evaluation of Alirocumab |
| NCT02585778 results posted | LPS14355 2015-000799-92, U1111-1172-4772 | Ph 3 | completed | 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) |
| NCT02642159 results posted | LPS14354 2015-001934-19, U1111-1172-5262 | Ph 4 | completed | Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia) |
| NCT02289963 results posted | EFC14074 U1111-1157-3294 | Ph 3 | completed | Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan |
| NCT01959971 | PDY13670 U1111-1141-4567 | Ph 1 | completed | Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol |
| NCT01926782 results posted | R727-CL-1308 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1) |
| NCT01617655 results posted | EFC12732 U1111-1128-5459, 2012-001096-37 | Ph 3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) |
| NCT01812707 results posted | DFI12361 U1111-1134-4749 | Ph 2 | completed | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan |
| NCT02107898 results posted | EFC13672 U1111-1115-7486 | Ph 3 | completed | Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN) |
| NCT01723735 | PKD12910 U1111-1131-3203, 2012-003049-13 | Ph 1 | completed | Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects |
| NCT01644188 results posted | EFC11569 U1111-1121-4315, 2011-004130-34 | Ph 3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II) |
| NCT01623115 ODYSSEY FH I results posted | EFC12492 U1111-1121-4275, 2011-005109-56 | Ph 3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy |
| NCT01507831 results posted | LTS11717 2011-002806-59, U1111-1121-3928 | Ph 3 | completed | Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) |
| NCT01644474 ODYSSEY MONO results posted | EFC11716 U1111-1124-1167, 2011-001424-38 | Ph 3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia |
| NCT01644175 results posted | EFC11568 U1111-1121-4356 | Ph 3 | completed | Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I) |
| NCT01709500 ODYSSEY FH II results posted | R727-CL-1112 | Ph 3 | completed | Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) |
| NCT01288443 results posted | DFI11565 U1111-1116-5252 | Ph 2 | completed | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy |
| NCT01288469 results posted | DFI11566 U1111-1117-9994 | Ph 2 | completed | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia |
Showing 50 of 53 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRALUENT FDA Label Details
Indications & Usage
FDA Label (PDF)PRALUENT is indicated for the treatment of Major adverse cardiovascular events risk reduction in adults; Hypercholesterolemia in adults; Heterozygous familial hypercholesterolemia in adults and pediatric patients (8 years and older); Homozygous familial hypercholesterolemia in adults.
Pro Intelligence Preview
Deep insights for PRALUENT
Revenue Insights
- • Q4-2025: $146M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • Generic/biosimilar risk
Trial Analysis
- • 54 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment