Alirocumab History and Updates

212 events · 1997 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

312

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Alirocumab since 1997, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (11)

2025

FDA approval (supplemental)Praluent (alirocumab) Receives FDA Supplemental Efficacy Approval· Oct 9, 2025
Primary completionAlirocumab Phase 3 EPIC-HIV Study Completes Primary Data Collection· Aug 24, 2025

2022

Pivotal publicationAlirocumab: PACMAN-AMI Study on Coronary Atherosclerosis in Acute MI Patients· Jan 1, 2022

2018

Pivotal publicationAlirocumab Cardiovascular Outcomes After Acute Coronary Syndrome Published· Jan 1, 2018

2016

Pivotal publicationAlirocumab: Severe Infection Treatment Discussed in Pivotal Publication· Jan 1, 2016

2015

Pivotal publicationAlirocumab Study on LDL Reduction in Dialysis Patients Published· Jan 1, 2015
Pivotal publicationAlirocumab Efficacy and Safety Published for Lipid and Cardiovascular Event…· Jan 1, 2015

2011

Pivotal publicationAlirocumab: Pivotal Publication on Simvastatin/Ezetimibe LDL-C Lowering· Jan 1, 2011

2009

Pivotal publicationAlirocumab Publication Explores Use in Patients on Stable Dialysis Regimen· Jan 1, 2009

2005

Pivotal publicationAtorvastatin Publication Explores Use in Type 2 Diabetes Hemodialysis· Jan 1, 2005

1997

Pivotal publicationAlirocumab: Nature Publication Links Toll Protein to Adaptive Immunity· Jan 1, 1997

Upcoming & expected milestones

Trial startedJun 29, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT05292404

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

Primary completionOct 15, 2026· ClinicalTrials.gov

Phase 4 primary completion: NCT06083961

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Progno

Primary completionOct 20, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Primary completionDec 1, 2026· ClinicalTrials.gov

Primary completion: NCT07375225

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

Primary completionDec 29, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT04781322

Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07581808

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

Trial startedJul 31, 2027· ClinicalTrials.gov

Phase 3 trial started: NCT07586540

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

Primary completionSep 30, 2027· ClinicalTrials.gov

Primary completion: NCT06858332

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

Primary completionOct 30, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT06385262

TOP 2301: Neoadjuvant Chemo for NSCLC

Primary completionMar 31, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT07586540

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

Past events

2026

Trial startedMay 31, 2026· ClinicalTrials.gov

Phase 4 trial started: NCT07581808

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

Primary completionMay 30, 2026· ClinicalTrials.gov

Primary completion: NCT07615179

Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

Trial registeredMay 29, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07615179

Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)

Trial registeredMay 14, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07586540

Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque

Trial registeredMay 12, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07581808

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

Primary completionApr 30, 2026· ClinicalTrials.gov

NA primary completion: NCT05587621

Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

Trial startedApr 14, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Trial registeredMar 17, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07477704

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Trial registeredJan 29, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07375225

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

2025

Primary completionOct 31, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

FDA approval (supplemental)Oct 9, 2025· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-47)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

Primary completionSep 16, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05553834

PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

Primary completionAug 24, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT03207945

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

Primary completionJul 11, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT03537742

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

Primary completionMay 31, 2025· ClinicalTrials.gov

Phase 4 primary completion: NCT04193306

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

Primary completionApr 15, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05001984

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

Trial startedApr 15, 2025· ClinicalTrials.gov

Trial started: NCT06858332

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

Trial startedMar 17, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06385262

TOP 2301: Neoadjuvant Chemo for NSCLC

Trial registeredMar 5, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06858332

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

Primary completionFeb 18, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT05469347

Alirocumab in Patients with Sepsis

2024

Primary completionDec 31, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT06080256

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

Trial startedDec 1, 2024· ClinicalTrials.gov

Trial started: NCT07375225

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy

Primary completionSep 15, 2024· ClinicalTrials.gov

Primary completion: NCT06052020

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

Primary completionAug 31, 2024· ClinicalTrials.gov

Primary completion: NCT06567418

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

Trial registeredAug 22, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06567418

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

Trial startedAug 1, 2024· ClinicalTrials.gov

Trial started: NCT06567418

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

Trial registeredApr 26, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06385262

TOP 2301: Neoadjuvant Chemo for NSCLC

Results postedApr 22, 2024· ClinicalTrials.gov

Trial results posted: NCT04189484

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Trial startedApr 1, 2024· ClinicalTrials.gov

NA trial started: NCT05587621

Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

FDA approval (supplemental)Mar 8, 2024· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-39)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

2023

Trial startedDec 30, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06080256

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

Trial registeredOct 16, 2023· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT06083961

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Progno

Trial startedOct 15, 2023· ClinicalTrials.gov

Phase 4 trial started: NCT06083961

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Progno

Trial registeredOct 12, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06080256

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

Primary completionOct 1, 2023· ClinicalTrials.gov

NA primary completion: NCT05043740

PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population

Trial registeredSep 25, 2023· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06052020

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

Trial startedSep 15, 2023· ClinicalTrials.gov

Trial started: NCT06052020

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

Trial startedMay 16, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05553834

PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

Primary completionMay 8, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT02959047

A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease

Results postedMay 6, 2023· ClinicalTrials.gov

Trial results posted: NCT03510884

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

Trial startedJan 4, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05469347

Alirocumab in Patients with Sepsis

2022

Trial registeredOct 20, 2022· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT05587621

Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

Trial startedOct 1, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05292404

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

Primary completionSep 30, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04790513

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

Trial registeredSep 23, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05553834

PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung

Trial registeredJul 21, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05469347

Alirocumab in Patients with Sepsis

Trial registeredJul 19, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05465278

Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

Trial registeredJun 24, 2022· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05430828

Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Primary completionApr 28, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT03344692

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

Primary completionMar 30, 2022· ClinicalTrials.gov

Phase 4 primary completion: NCT05465278

Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

Trial registeredMar 23, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05292404

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

Primary completionJan 30, 2022· ClinicalTrials.gov

Primary completion: NCT05430828

Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Pivotal publicationJan 1, 2022· PubMed

Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized (JAMA)

PACMAN-AMI — Vascular Effects of Alirocumab in Acute MI-Patients

2021

Trial startedOct 31, 2021· ClinicalTrials.gov

NA trial started: NCT05043740

PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population

Trial startedOct 19, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04781322

Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Primary completionOct 13, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03067844

Vascular Effects of Alirocumab in Acute MI-Patients

Trial registeredSep 14, 2021· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT05043740

PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population

Trial registeredAug 12, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05001984

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

Trial startedAug 1, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT05001984

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

Primary completionJun 30, 2021· ClinicalTrials.gov

NA primary completion: NCT04613167

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

Primary completionJun 30, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT03718286

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

Results postedJun 29, 2021· ClinicalTrials.gov

Trial results posted: NCT03156621

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Results postedJun 15, 2021· ClinicalTrials.gov

Trial results posted: NCT03694197

Long Term Safety Study of PRALUENT

Results postedMay 7, 2021· ClinicalTrials.gov

Trial results posted: NCT02957682

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Trial startedApr 22, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04790513

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

Trial startedApr 12, 2021· ClinicalTrials.gov

Phase 4 trial started: NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Primary completionApr 7, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04189484

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

FDA approval (supplemental)Apr 1, 2021· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-29)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

FDA approval (supplemental)Apr 1, 2021· FDA

FDA approved supplemental application for Praluent (alirocumab) — Labeling (BLA 125559 S-30)

Sponsor: REGENERON PHARMACEUTICALS. Class: Labeling.

Trial registeredMar 10, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04790513

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

Trial registeredMar 4, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04781322

Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers

Primary completionJan 31, 2021· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT03634293

Treatment of Severe Infection With Antihyperlipidemia Drug

Trial registeredJan 29, 2021· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Primary completionJan 14, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03510884

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

2020

Primary completionDec 31, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT03750760

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

Primary completionDec 31, 2020· ClinicalTrials.gov

Primary completion: NCT03533959

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

Results postedDec 29, 2020· ClinicalTrials.gov

Trial results posted: NCT03510715

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

Trial startedNov 10, 2020· ClinicalTrials.gov

NA trial started: NCT04613167

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

Trial registeredNov 3, 2020· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT04613167

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

Primary completionOct 31, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT02941016

Vascular Inflammation and Cholesterol Lowering Therapy

Primary completionSep 30, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT03529253

Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in

Primary completionSep 30, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT03552432

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

Primary completionSep 4, 2020· ClinicalTrials.gov

Primary completion: NCT03379558

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

Primary completionAug 31, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT03480568

Alirocumab in Patients on a Stable Dialysis Regimen

Results postedAug 5, 2020· ClinicalTrials.gov

Trial results posted: NCT01576484

Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participan

Primary completionJun 30, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT03542110

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

Results postedJun 17, 2020· ClinicalTrials.gov

Trial results posted: NCT01604824

A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Propro

Results postedMay 1, 2020· ClinicalTrials.gov

Trial results posted: NCT02326220

Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotei

Primary completionApr 17, 2020· ClinicalTrials.gov

EARLY_Phase 1 primary completion: NCT03507374

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Primary completionApr 8, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT03694197

Long Term Safety Study of PRALUENT

Results postedMar 30, 2020· ClinicalTrials.gov

Trial results posted: NCT02476006

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controll

FDA approval (supplemental)Mar 10, 2020· FDA

FDA approved supplemental application for Praluent (alirocumab) — Labeling (BLA 125559 S-24)

Sponsor: REGENERON PHARMACEUTICALS. Class: Labeling.

Trial startedMar 7, 2020· ClinicalTrials.gov

Trial started: NCT05430828

Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Primary completionMar 5, 2020· ClinicalTrials.gov

Phase 4 primary completion: NCT02957682

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Primary completionFeb 17, 2020· ClinicalTrials.gov

Phase 3 primary completion: NCT03510715

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

Trial startedJan 31, 2020· ClinicalTrials.gov

Phase 4 trial started: NCT03750760

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

Trial startedJan 7, 2020· ClinicalTrials.gov

Phase 1 trial started: NCT04189484

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

2019

Primary completionDec 31, 2019· ClinicalTrials.gov

Phase 2 primary completion: NCT03004001

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

Trial registeredDec 10, 2019· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT04193306

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

Trial registeredDec 6, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04189484

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Primary completionNov 30, 2019· ClinicalTrials.gov

Phase 4 primary completion: NCT02992301

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

Trial startedNov 18, 2019· ClinicalTrials.gov

Phase 4 trial started: NCT04193306

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

Primary completionSep 30, 2019· ClinicalTrials.gov

NA primary completion: NCT03355027

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

Results postedSep 30, 2019· ClinicalTrials.gov

Trial results posted: NCT02715726

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

Primary completionSep 27, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT03156621

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Results postedSep 9, 2019· ClinicalTrials.gov

Trial results posted: NCT02984982

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

Results postedSep 9, 2019· ClinicalTrials.gov

Trial results posted: NCT03415178

Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk

Results postedSep 6, 2019· ClinicalTrials.gov

Trial results posted: NCT02938949

Alirocumab in Patients With Acute Myocardial Infarction

Results postedSep 6, 2019· ClinicalTrials.gov

Trial results posted: NCT02890992

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

Trial startedMay 13, 2019· ClinicalTrials.gov

Phase 2 trial started: NCT03537742

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

FDA approval (supplemental)Apr 26, 2019· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-19)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

FDA approval (supplemental)Apr 26, 2019· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-20)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

Primary completionApr 12, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT02476006

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controll

Results postedMar 18, 2019· ClinicalTrials.gov

Trial results posted: NCT01663402

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

Trial startedMar 11, 2019· ClinicalTrials.gov

Phase 2 trial started: NCT03718286

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

Trial startedFeb 12, 2019· ClinicalTrials.gov

Phase 3 trial started: NCT03344692

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

Trial startedJan 31, 2019· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT03634293

Treatment of Severe Infection With Antihyperlipidemia Drug

2018

Trial registeredNov 23, 2018· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03750760

Early Alirocumab to Reduce LDL-C in Myocardial Infarction

FDA approval (supplemental)Nov 6, 2018· FDA

FDA approved supplemental application for Praluent (alirocumab) — Labeling (BLA 125559 S-18)

Sponsor: REGENERON PHARMACEUTICALS. Class: Labeling.

Trial startedOct 30, 2018· ClinicalTrials.gov

EARLY_Phase 1 trial started: NCT03507374

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Trial registeredOct 24, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03718286

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

Trial registeredOct 3, 2018· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03694197

Long Term Safety Study of PRALUENT

Trial startedSep 28, 2018· ClinicalTrials.gov

Phase 4 trial started: NCT03694197

Long Term Safety Study of PRALUENT

Primary completionSep 13, 2018· ClinicalTrials.gov

Phase 2 primary completion: NCT02890992

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

Trial startedAug 31, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03510715

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

Primary completionAug 31, 2018· ClinicalTrials.gov

Phase 4 primary completion: NCT02938949

Alirocumab in Patients With Acute Myocardial Infarction

FDA approval (supplemental)Aug 22, 2018· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-14)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

Trial registeredAug 16, 2018· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT03634293

Treatment of Severe Infection With Antihyperlipidemia Drug

Primary completionAug 9, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT03415178

Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk

Primary completionAug 6, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02715726

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

Trial startedAug 4, 2018· ClinicalTrials.gov

Phase 4 trial started: NCT03542110

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

Primary completionJul 27, 2018· ClinicalTrials.gov

Phase 4 primary completion: NCT02984982

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

Results postedJul 24, 2018· ClinicalTrials.gov

Trial results posted: NCT01954394

Open Label Study of Long Term Safety Evaluation of Alirocumab

FDA approval (supplemental)Jul 20, 2018· FDA

FDA approved supplemental application for Praluent (alirocumab) — Labeling (BLA 125559 S-15)

Sponsor: REGENERON PHARMACEUTICALS. Class: Labeling.

Trial registeredJun 11, 2018· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03552432

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

Primary completionJun 4, 2018· ClinicalTrials.gov

Phase 1 primary completion: NCT03014830

Alirocumab and Reverse Cholesterol Transport

Trial startedMay 31, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03510884

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

Trial registeredMay 31, 2018· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03542110

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

Trial registeredMay 25, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03537742

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

Trial registeredMay 23, 2018· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT03533959

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

Trial registeredMay 18, 2018· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT03529253

Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in

Results postedMay 17, 2018· ClinicalTrials.gov

Trial results posted: NCT02585778

Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia

Results postedMay 7, 2018· ClinicalTrials.gov

Trial results posted: NCT02584504

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

Trial startedMay 1, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03480568

Alirocumab in Patients on a Stable Dialysis Regimen

Results postedMay 1, 2018· ClinicalTrials.gov

Trial results posted: NCT02642159

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed

Trial startedMay 1, 2018· ClinicalTrials.gov

Phase 4 trial started: NCT05465278

Alirocumab and Plaque Burden In Familial Hypercholesterolaemia

Trial startedApr 30, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03207945

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

Trial registeredApr 27, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03510715

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

Trial registeredApr 27, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03510884

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

Trial registeredApr 25, 2018· ClinicalTrials.gov

EARLY_Phase 1 trial registered on ClinicalTrials.gov: NCT03507374

PCSK9 Inhibition in Patients With Symptomatic Intracranial Atherosclerosis

Trial startedApr 1, 2018· ClinicalTrials.gov

Phase 4 trial started: NCT03529253

Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in

Trial registeredMar 29, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03480568

Alirocumab in Patients on a Stable Dialysis Regimen

Trial startedMar 29, 2018· ClinicalTrials.gov

Phase 3 trial started: NCT03415178

Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk

Trial registeredJan 30, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03415178

Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk

Primary completionJan 23, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT01663402

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

Pivotal publicationJan 1, 2018· PubMed

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. (N Engl J Med)

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

2017

Trial registeredDec 20, 2017· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT03379558

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

Trial startedDec 19, 2017· ClinicalTrials.gov

Trial started: NCT03379558

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

Trial startedDec 18, 2017· ClinicalTrials.gov

Trial started: NCT03533959

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

Trial startedNov 30, 2017· ClinicalTrials.gov

NA trial started: NCT03355027

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

Trial registeredNov 28, 2017· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT03355027

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

Primary completionNov 27, 2017· ClinicalTrials.gov

Phase 1 primary completion: NCT02979015

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

Trial registeredNov 17, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03344692

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

Trial startedOct 3, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03156621

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

FDA approval (supplemental)Sep 20, 2017· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-6)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

Trial startedAug 23, 2017· ClinicalTrials.gov

Phase 4 trial started: NCT03552432

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

FDA approval (supplemental)Jul 27, 2017· FDA

FDA approved supplemental application for Praluent (alirocumab) — Manufacturing (CMC) (BLA 125559 S-2)

Sponsor: REGENERON PHARMACEUTICALS. Class: Manufacturing (CMC).

Trial startedJul 17, 2017· ClinicalTrials.gov

Phase 4 trial started: NCT02959047

A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease

Trial registeredJul 5, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03207945

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

Primary completionJun 30, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT01954394

Open Label Study of Long Term Safety Evaluation of Alirocumab

Results postedJun 26, 2017· ClinicalTrials.gov

Trial results posted: NCT02289963

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

Trial startedJun 1, 2017· ClinicalTrials.gov

Phase 1 trial started: NCT03014830

Alirocumab and Reverse Cholesterol Transport

Trial registeredMay 17, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03156621

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Trial startedApr 25, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03067844

Vascular Effects of Alirocumab in Acute MI-Patients

FDA approval (supplemental)Apr 24, 2017· FDA

FDA approved supplemental application for Praluent (alirocumab) — Efficacy (BLA 125559 S-1)

Sponsor: REGENERON PHARMACEUTICALS. Class: Efficacy.

Primary completionApr 5, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02584504

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

Primary completionApr 3, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02585778

Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia

Primary completionMar 22, 2017· ClinicalTrials.gov

Phase 4 primary completion: NCT02642159

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed

Results postedMar 21, 2017· ClinicalTrials.gov

Trial results posted: NCT01926782

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Prima

Results postedMar 15, 2017· ClinicalTrials.gov

Trial results posted: NCT02023879

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

Trial registeredMar 1, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03067844

Vascular Effects of Alirocumab in Acute MI-Patients

Trial startedJan 31, 2017· ClinicalTrials.gov

Phase 4 trial started: NCT02938949

Alirocumab in Patients With Acute Myocardial Infarction

Trial startedJan 31, 2017· ClinicalTrials.gov

Phase 2 trial started: NCT03004001

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

Trial registeredJan 9, 2017· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03014830

Alirocumab and Reverse Cholesterol Transport

2016

Trial registeredDec 28, 2016· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03004001

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

Primary completionDec 22, 2016· ClinicalTrials.gov

Phase 2 primary completion: NCT01576484

Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participan

Trial registeredDec 14, 2016· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT02992301

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

Trial registeredDec 7, 2016· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT02984982

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

Trial registeredDec 1, 2016· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02979015

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

Trial startedNov 30, 2016· ClinicalTrials.gov

Phase 4 trial started: NCT02992301

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

Trial startedNov 29, 2016· ClinicalTrials.gov

Phase 1 trial started: NCT02979015

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

Trial startedNov 15, 2016· ClinicalTrials.gov

Phase 4 trial started: NCT02984982

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

Trial registeredNov 8, 2016· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT02957682

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Trial registeredNov 8, 2016· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT02959047

A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease

Trial startedNov 2, 2016· ClinicalTrials.gov

Phase 4 trial started: NCT02957682

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Trial startedOct 31, 2016· ClinicalTrials.gov

Phase 4 trial started: NCT02941016

Vascular Inflammation and Cholesterol Lowering Therapy

Trial registeredOct 21, 2016· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT02941016

Vascular Inflammation and Cholesterol Lowering Therapy

Trial registeredOct 19, 2016· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT02938949

Alirocumab in Patients With Acute Myocardial Infarction

Trial startedSep 15, 2016· ClinicalTrials.gov

Phase 2 trial started: NCT02890992

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

Trial registeredSep 7, 2016· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT02890992

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

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.