Praluent

(Alirocumab)

ApprovedMonoclonal antibody

Alirocumab is used to lower cholesterol levels in people who have high cholesterol or heart disease, helping to reduce the risk of heart attacks and strokes.[2] Praluent is currently approved and in use across 10 indications[4].[1]

Praluent is one of 270 small molecule programs targeting Atherosclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

269

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AtherosclerosisTerminated

Abnormal Circulating Lipid ConcentrationUnknown

Cardiovascular DiseaseUnknown

Acute Myocardial InfarctionActive, not recruiting

Myocardial InfarctionActive, not recruiting

Liver DiseaseRecruiting

HypercholesterolemiaCompleted

Acute Coronary SyndromeCompleted

Peripheral Arterial DiseaseCompleted

PCSK9 InhibitorRecruiting

AtherosclerosisApproved

Terminated

Abnormal Circulating Lipid ConcentrationPreclinical

Unknown

Cardiovascular DiseasePreclinical

Unknown

Acute Myocardial InfarctionApproved

Active, not recruiting

Myocardial InfarctionApproved

Active, not recruiting

Liver DiseasePhase 1

Recruiting

HypercholesterolemiaPhase 3

Completed

Acute Coronary SyndromeApproved

Completed

Peripheral Arterial DiseaseApproved

Completed

PCSK9 InhibitorApproved

Recruiting

Competition

Competitive Landscape

146 competitors in Cardiovascular Disease

#DrugCompanyPhaseTrials

Leqvio

Novartis

Approved

7 2

Lescol

Cellcept

Lopid

Praluent

1 6

Trental

VValidus Pharmaceuticals

Approved

—7

Nitrostat

VViatris Specialty LLC

Normodyne

Colcrys

1 10

Pelacarsen

Novartis

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Atherosclerosis

NCT06083961

Post-ApprovalRecruiting

PCSK9 Inhibitor

NCT05292404

Phase 1Recruiting

Liver Disease

NCT04781322

Q1 2027

Phase 2Recruiting

Hypercholesterolemia

NCT07477704

Q3 2027

Recruiting

Cardiovascular Disease

NCT06858332

Clinical

Trials by Indication[1]

Hypercholesterolemia19 trials

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)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01926782·803 enrolled

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT01644474·103 enrolled

Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

Completed· Regeneron logo

Regeneron·Phase 2·NCT01266876·77 enrolled

Show 16 more trials

Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

Completed· Sanofi logo

Sanofi·Phase 3·NCT02584504·163 enrolled

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02476006·998 enrolled

Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Completed· Sanofi logo

Sanofi·Phase 3·NCT03415178·69 enrolled

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01644188·720 enrolled

Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT02715726·615 enrolled

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

Completed· Sanofi logo

Sanofi·Phase 2·NCT01812707·100 enrolled

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT01288469·92 enrolled

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

Completed· Regeneron logo

Regeneron·Phase 2·NCT01604824·23 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01644175·316 enrolled

Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02023879·233 enrolled

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Completed· Sanofi logo

Sanofi·Phase 2·NCT01288443·183 enrolled

Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Completed· Sanofi logo

Sanofi·Phase 3·NCT02289963·199 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01507831·2,341 enrolled

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)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01709513·314 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02585778·517 enrolled

A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia

Recruiting· Regeneron logo

Regeneron·Phase 2·NCT07477704·420 enrolled

Familial Hypercholesterolemia8 trials

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT02890992·42 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT01623115·486 enrolled

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy

Completed· Regeneron logo

Regeneron·Phase 3·NCT02326220·62 enrolled

Show 5 more trials

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01617655·107 enrolled

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)

Completed· Regeneron logo

Regeneron·Phase 2·NCT01576484·58 enrolled

Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01709500·249 enrolled

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510884·153 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02107898·216 enrolled

Atherosclerosis5 trials

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile

Not yet recruiting·—·Phase 4·NCT06083961·200 enrolled

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Terminated·UUniversity of Utah·Phase 1·NCT03507374·20 enrolled

The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial

Terminated·MMinneapolis Heart Institute Foundation·Phase 4·NCT03542110·46 enrolled

Show 2 more trials

Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis

Active, not recruiting·—·Phase 2·NCT05001984·60 enrolled

To Evaluate the Efficacy of Alirocumab for Neoatherosclerosis by Using OCT, in Comparison With Standard Statin Therapy

Unknown status·KKobe University··NCT03533959·31 enrolled

LDL-cholesterol3 trials

Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI

Completed·PPopulation Health Research Institute·Phase 2·NCT03718286·97 enrolled

Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol

Completed· Sanofi logo

Sanofi·Phase 1·NCT01959971·20 enrolled

Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease

Unknown status·—·N/A·NCT03355027·60 enrolled

Coronary Artery Disease3 trials

Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound

Unknown status·KKobe University·Phase 4·NCT03529253·30 enrolled

The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

Unknown status·KKobe University·Phase 4·NCT03552432·24 enrolled

Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment

Unknown status·UUniversity Medical Centre Ljubljana·N/A·NCT04613167·70 enrolled

32 more indications

Atherosclerotic Cardiovascular Disease3 trials

Alirocumab and Cardiovascular Outcomes in Patients Without a Previous Myocardial Infarction or Stroke

Completed· Sanofi logo

Sanofi··NCT07734753·4,006 enrolled

Impact of Alirocumab on Cardiovascular Events in Individuals With Atherosclerotic Cardiovascular Disease But Without Prior Ischemic Events

Completed· Sanofi logo

Sanofi··NCT07615179·4,545 enrolled

Reduction in Low-Density Lipoprotein Cholesterol With Alirocumab 150 mg as Compared With Inclisiran: Comparative Evaluation Via Target-Trial Emulation and G-Computation

Completed· Sanofi logo

Sanofi··NCT07615166·996 enrolled

Symptomatic Intracranial Atherosclerotic Stenosis2 trials

Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis (EAST-aICAS)

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 3·NCT06080256·80 enrolled

Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis ----a Pilot Study

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University··NCT06052020·50 enrolled

Type 2 Diabetes2 trials

Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes

Completed·NNantes University Hospital·Phase 3·NCT03344692·22 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 4·NCT02642159·413 enrolled

Tics2 trials

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT02979015·35 enrolled

Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)

Completed· Sanofi logo

Sanofi·Phase 1·NCT01448304·24 enrolled

Acute Coronary Syndrome2 trials

Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 4·NCT02984982·206 enrolled

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Completed· Sanofi logo

Sanofi·Phase 3·NCT01663402·18,924 enrolled

Homozygous Familial Hypercholesterolemia2 trials

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510715·18 enrolled

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Completed· Regeneron logo

Regeneron·Phase 3·NCT03156621·69 enrolled

Treatment2 trials

Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01443650·36 enrolled

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01730053·305 enrolled

Efficacy and Safety2 trials

Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients

Completed·LLIB Therapeutics LLC·Phase 3·NCT04790513·204 enrolled

Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

Completed· Regeneron logo

Regeneron·Phase 3·NCT01730040·355 enrolled

PCSK9 Inhibitor2 trials

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

Recruiting·SShanghai Tong Ren Hospital·Phase 4·NCT05292404·160 enrolled

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT04189484·72 enrolled

Myocardial Infarction1 trial

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

Withdrawn·IImperial College London·Phase 4·NCT03750760

Nephrotic Syndrome1 trial

Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome

Terminated·GGloria Vega·Phase 2·NCT03004001·3 enrolled

Cardiac Allograft Vasculopathy1 trial

Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients

Unknown status·IInstitute for Clinical and Experimental Medicine·Phase 4·NCT04193306·126 enrolled

Sepsis1 trial

Alirocumab in Patients with Sepsis

Completed·JJonathan Sevransky·Phase 1·NCT05469347·50 enrolled

Acute1 trial

Vascular Effects of Alirocumab in Acute MI-Patients

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT03067844·294 enrolled

Acute Myocardial Infarction1 trial

Alirocumab in Patients With Acute Myocardial Infarction

Completed·VVirginia Commonwealth University·Phase 4·NCT02938949·20 enrolled

Pregnancy1 trial

Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

Terminated· Regeneron logo

Regeneron··NCT03379558·37 enrolled

Dialysis1 trial

Alirocumab in Patients on a Stable Dialysis Regimen

Unknown status·—·Phase 3·NCT03480568·20 enrolled

Cardiovascular Disease1 trial

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Recruiting· Novartis logo

Novartis··NCT06858332·2,382 enrolled

Atherosclerotic Plaque1 trial

Assessment of Atherosclerotic Plaque Characteristics Change by DCE-MRI With Alirocumab

Unknown status·WWestside Medical Associates of Los Angeles·Phase 4·NCT02992301·35 enrolled

Hypercholesterolaemia1 trial

Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

Completed·FFundación Hipercolesterolemia Familiar·Phase 4·NCT05465278·104 enrolled

Peripheral Arterial Disease1 trial

A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease

Completed·UUniversity of Virginia·Phase 4·NCT02959047·40 enrolled

Outcome1 trial

Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients

Recruiting·YYun Dai Chen··NCT06567418·10,000 enrolled

Hepatic Impairment1 trial

Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01670734·25 enrolled

Single Dose1 trial

Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

Completed· Sanofi logo

Sanofi·Phase 1·NCT01448239·24 enrolled

Cholesterol1 trial

Alirocumab and Reverse Cholesterol Transport

Completed·WWashington University School of Medicine·Phase 1·NCT03014830·28 enrolled

Lip1 trial

Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01723735·79 enrolled

Hyperlipidemia1 trial

Treatment of Severe Infection With Antihyperlipidemia Drug

Unknown status·WWolfson Medical Center·Phase 2/3·NCT03634293·712 enrolled

Dyslipidemias1 trial

Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)

Completed·UUniversity of California, San Francisco·Phase 3·NCT03207945·118 enrolled

Non-Small Cell Lung Cancer1 trial

Safety, Efficacy, and Tumor Immune Microenvironment Changes With Neoadjuvant Chemotherapy and Cemiplimab With or Without Alirocumab in Stage 1B-3A Non-Small Cell Lung Cancer: TOP 2301

Suspended·DDuke University·Phase 2·NCT06385262·63 enrolled

Vasculopathy1 trial

PCSK9 Inhibition After Heart Transplantation

Completed·SStanford University·Phase 2·NCT03537742·114 enrolled

Liver Disease1 trial

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Study of Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Recruiting·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 1·NCT04781322·100 enrolled

Unspecified3 trials

Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT01785329·60 enrolled

Open Label Study of Long Term Safety Evaluation of Alirocumab

Completed· Sanofi logo

Sanofi·Phase 3·NCT01954394·986 enrolled

Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Completed· Sanofi logo

Sanofi·Phase 1·NCT01448317·32 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 24, 2015

PRALUENT

BLA BLA125559

Jul 24, 2015

PRALUENT

NDA BLA125559

Jul 27, 2017

PRALUENT

NDA BLA125559

Sep 20, 2017

PRALUENT

NDA BLA125559

Jul 20, 2018

PRALUENT

NDA BLA125559

Aug 22, 2018

PRALUENT

NDA BLA125559

Nov 6, 2018

PRALUENT

NDA BLA125559

Apr 26, 2019

PRALUENT

NDA BLA125559

Apr 26, 2019

PRALUENT

NDA BLA125559

Mar 10, 2020

PRALUENT

NDA BLA125559

Apr 1, 2021

PRALUENT

NDA BLA125559

Apr 1, 2021

PRALUENT

NDA BLA125559

Mar 8, 2024

PRALUENT

NDA BLA125559

Oct 9, 2025

PRALUENT

NDA BLA125559

Sources

References

[1]
ClinicalTrials.gov — 82 trial records for Alirocumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Praluent drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alirocumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alirocumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125559). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Regeneron company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Subtilisin/kexin Type 9 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Regeneron

Praluent

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Hypercholesterolemia19 trials

Familial Hypercholesterolemia8 trials

Atherosclerosis5 trials

LDL-cholesterol3 trials

Coronary Artery Disease3 trials

Atherosclerotic Cardiovascular Disease3 trials

Symptomatic Intracranial Atherosclerotic Stenosis2 trials

Type 2 Diabetes2 trials

Tics2 trials

Acute Coronary Syndrome2 trials

Homozygous Familial Hypercholesterolemia2 trials

Treatment2 trials

Efficacy and Safety2 trials

PCSK9 Inhibitor2 trials

Myocardial Infarction1 trial

Nephrotic Syndrome1 trial

Cardiac Allograft Vasculopathy1 trial

Sepsis1 trial

Acute1 trial

Acute Myocardial Infarction1 trial

Pregnancy1 trial

Dialysis1 trial

Cardiovascular Disease1 trial

Atherosclerotic Plaque1 trial

Hypercholesterolaemia1 trial

Peripheral Arterial Disease1 trial

Outcome1 trial

Hepatic Impairment1 trial

Single Dose1 trial

Cholesterol1 trial

Lip1 trial

Hyperlipidemia1 trial

Dyslipidemias1 trial

Non-Small Cell Lung Cancer1 trial

Vasculopathy1 trial

Liver Disease1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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