Evolocumab History and Updates

213 events · 2010 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

20
FDA Approvals
0
Label Revisions
445
Trial Milestones
10
Pivotal Publications
Evolocumab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20102011201220132014201520162017201820192020202120222023202420252026202720282029Trial: NCT06081153 2026-12-01 → 2029-01-15 (primary completion)Trial: NCT07545226 2026-04-20 → 2026-09-08 (primary completion)Trial: NCT06700720 2026-02-28 → 2026-06-30 (primary completion)Trial: NCT07422285 2026-01-16 → 2026-06-30 (primary completion)Trial: NCT07388420 2026-01-02 → 2026-12-31 (primary completion)Trial: NCT07036991 2025-07-30 → 2026-06-01 (primary completion)Trial: NCT06858332 2025-04-15 → 2027-09-30 (primary completion)Trial: NCT06496243 2024-12-02 → 2026-11-30 (primary completion)Trial: NCT06284564 2024-08-07 → 2026-10-01 (primary completion)Trial: NCT05587621 2024-04-01 → 2026-04-30 (primary completion)Trial: NCT06140095 2024-02-29 → 2025-12-31 (primary completion)Trial: NCT06134635 2023-12-01 → 2024-11-01 (primary completion)Trial: NCT05974345 2023-11-03 → 2023-12-15 (primary completion)Trial: NCT05976893 2023-08-01 → 2025-12-31 (primary completion)Trial: NCT06364124 2023-06-01 → 2024-06-01 (primary completion)Trial: NCT05741086 2023-04-15 → 2024-08-31 (primary completion)Trial: NCT05613426 2023-04-03 → 2025-12-30 (primary completion)Trial: NCT05697185 2023-02-01 → 2024-02-01 (primary completion)Trial: NCT05641753 2022-12-06 → 2027-07-01 (primary completion)Trial: NCT05661552 2022-12-01 → 2025-02-05 (primary completion)Trial: NCT05585151 2022-11-09 → 2024-04-01 (primary completion)Trial: NCT05579418 2022-11-01 → 2024-10-30 (primary completion)Trial: NCT05284747 2022-10-26 → 2027-05-29 (primary completion)Trial: NCT05802108 2022-07-01 → 2024-06-30 (primary completion)Trial: NCT05144529 2022-03-22 → 2024-09-27 (primary completion)Trial: NCT05152888 2022-03-03 → 2027-03-31 (primary completion)Trial: NCT05418166 2021-12-23 → 2022-09-01 (primary completion)Trial: NCT05043740 2021-10-31 → 2023-10-01 (primary completion)Trial: NCT04937413 2021-10-08 → 2023-09-13 (primary completion)Trial: NCT04951856 2021-09-29 → 2026-05-22 (primary completion)Trial: NCT04992065 2021-08-03 → 2022-04-26 (primary completion)Trial: NCT04941105 2021-06-01 → 2022-05-17 (primary completion)Trial: NCT04710368 2021-05-04 → 2022-10-28 (primary completion)Trial: NCT04573777 2021-04-23 → 2021-12-16 (primary completion)Trial: NCT04790513 2021-04-22 → 2022-09-30 (primary completion)Trial: NCT04730973 2021-03-01 → 2022-03-31 (primary completion)Trial: NCT04510844 2021-03-01 → 2021-10-01 (primary completion)Trial: NCT04719221 2021-03-01 → 2024-12-31 (primary completion)Trial: NCT04608474 2021-02-17 → 2024-01-11 (primary completion)Trial: NCT04338165 2021-01-08 → 2022-11-30 (primary completion)Trial: NCT06740552 2021-01-01 → 2024-12-31 (primary completion)Trial: NCT04100434 2021-01-01 → 2022-06-01 (primary completion)Trial: NCT06081803 2020-12-05 → 2025-12-31 (primary completion)Trial: NCT04613167 2020-11-10 → 2021-06-30 (primary completion)Trial: NCT04141579 2020-11-10 → 2023-11-09 (primary completion)Trial: NCT04659525 2020-11-01 → 2021-11-30 (primary completion)Trial: NCT04539223 2020-08-28 → 2022-04-30 (primary completion)Trial: NCT04397653 2020-05-04 → 2020-11-19 (primary completion)Trial: NCT05430828 2020-03-07 → 2022-01-30 (primary completion)Trial: NCT04306471 2020-02-24 → 2021-02-04 (primary completion)Trial: NCT04189484 2020-01-07 → 2021-04-07 (primary completion)Trial: NCT04034485 2019-12-07 → 2022-09-12 (primary completion)Trial: NCT04303377 2019-11-18 → 2020-01-02 (primary completion)Trial: NCT04101643 2019-09-29 → 2023-01-03 (primary completion)Trial: NCT04087915 2019-09-11 → 2021-12-31 (primary completion)Trial: NCT04073134 2019-09-11 → 2022-03-27 (primary completion)Trial: NCT03931161 2019-09-04 → 2023-05-06 (primary completion)Trial: NCT04082442 2019-09-01 → 2024-10-25 (primary completion)Trial: NCT03811223 2019-08-31 → 2021-01-31 (primary completion)Trial: NCT03851263 2019-08-30 → 2021-08-27 (primary completion)Trial: NCT03944577 2019-07-15 → 2023-03-28 (primary completion)Trial: NCT03872401 2019-06-11 → 2025-07-25 (primary completion)Trial: NCT03734211 2019-06-10 → 2023-05-20 (primary completion)Trial: NCT03829046 2019-06-03 → 2021-11-15 (primary completion)Trial: NCT03900026 2019-05-30 → 2025-01-30 (primary completion)Trial: NCT03433755 2019-05-09 → 2020-04-24 (primary completion)Trial: NCT03626831 2019-04-04 → 2021-04-15 (primary completion)Trial: NCT03689946 2019-03-19 → 2023-01-28 (primary completion)Trial: NCT03869073 2019-02-11 → 2021-02-11 (primary completion)Trial: NCT06231459 2019-01-01 → 2020-12-31 (primary completion)Trial: NCT03791593 2018-12-03 → 2021-06-30 (primary completion)Trial: NCT03570697 2018-11-19 → 2020-12-18 (primary completion)Trial: NCT03331666 2018-11-16 → 2020-02-04 (primary completion)Trial: NCT03932721 2018-10-01 → 2021-06-30 (primary completion)Trial: NCT03403374 2018-08-04 → 2019-11-27 (primary completion)Trial: NCT03515304 2018-05-20 → 2024-10-25 (primary completion)Trial: NCT03500302 2018-05-04 → 2019-11-30 (primary completion)Trial: NCT03258281 2018-05-01 → 2019-09-01 (primary completion)Trial: NCT04665830 2018-05-01 → 2020-05-01 (primary completion)Trial: NCT03287609 2018-01-23 → 2019-05-20 (primary completion)Trial: NCT03337698 2017-12-27 → 2025-10-14 (primary completion)Trial: NCT04306081 2017-12-14 → 2020-12-30 (primary completion)Trial: NCT04313270 2017-12-01 → 2022-12-01 (primary completion)Trial: NCT03096288 2017-10-03 → 2020-11-02 (primary completion)Trial: NCT03247972 2017-08-11 → 2019-09-01 (primary completion)Trial: NCT02833844 2017-05-22 → 2019-07-09 (primary completion)Trial: NCT03060577 2017-04-27 → 2021-12-17 (primary completion)Trial: NCT03193047 2017-04-07 → 2018-01-29 (primary completion)Trial: NCT03429998 2017-04-01 → 2018-01-28 (primary completion)Trial: NCT03080935 2017-03-13 → 2022-03-04 (primary completion)Trial: NCT02957604 2016-12-22 → 2020-09-02 (primary completion)Trial: NCT02941016 2016-10-31 → 2020-10-31 (primary completion)Trial: NCT02948777 2016-10-31 → 2018-06-30 (primary completion)Trial: NCT02624869 2016-09-10 → 2021-06-01 (primary completion)Trial: NCT02867813 2016-09-02 → 2022-03-21 (primary completion)Trial: NCT02739984 2016-05-17 → 2017-08-03 (primary completion)Trial: NCT02729025 2016-04-14 → 2018-04-05 (primary completion)Trial: NCT02662569 2016-04-14 → 2017-12-06 (primary completion)Trial: NCT02392559 2016-03-24 → 2019-11-25 (primary completion)Trial: NCT02634580 2016-02-27 → 2017-08-10 (primary completion)Trial: NCT05184530 2016-01-31 → 2020-12-31 (primary completion)Trial: NCT02585895 2015-12-21 → 2016-09-01 (primary completion)Trial: NCT02304484 2014-11-24 → 2018-03-09 (primary completion)Trial: NCT02207634 2014-09-10 → 2016-11-11 (primary completion)Trial: NCT02275156 2014-08-19 → 2014-12-19 (primary completion)Trial: NCT02189837 2014-07-08 → 2015-02-13 (primary completion)Trial: NCT01984424 2013-12-10 → 2015-11-10 (primary completion)Trial: NCT01953328 2013-10-31 → 2014-06-30 (primary completion)Trial: NCT05984953 2013-08-01 → 2022-10-28 (primary completion)Trial: NCT01879319 2013-07-11 → 2013-11-15 (primary completion)Trial: NCT01854918 2013-04-23 → 2018-05-31 (primary completion)Trial: NCT01813422 2013-04-18 → 2016-07-12 (primary completion)Trial: NCT01849497 2013-04-18 → 2013-09-02 (primary completion)Trial: NCT01764633 2013-02-08 → 2016-11-11 (primary completion)Trial: NCT01763918 2013-02-07 → 2013-11-27 (primary completion)Trial: NCT01763905 2013-01-24 → 2013-11-19 (primary completion)Trial: NCT01763827 2013-01-21 → 2013-10-10 (primary completion)Trial: NCT01763866 2013-01-15 → 2013-11-12 (primary completion)Trial: NCT01652703 2012-07-10 → 2013-05-14 (primary completion)Trial: NCT01624142 2012-06-01 → 2018-05-11 (primary completion)Trial: NCT01588496 2012-04-05 → 2014-01-31 (primary completion)Trial: NCT01516879 2012-01-05 → 2013-10-14 (primary completion)Trial: NCT01439880 2011-10-07 → 2018-06-20 (primary completion)Trial: NCT01375751 2011-08-02 → 2012-05-16 (primary completion)Trial: NCT01375764 2011-07-28 → 2012-05-08 (primary completion)Trial: NCT01375777 2011-07-06 → 2012-03-02 (primary completion)Trial: NCT01380730 2011-07-01 → 2012-04-05 (primary completion)Trial: NCT01133522 2010-06-01 → 2011-09-14 (primary completion)FDA approval — 2015-08-27 FDA approved Repatha (evolocumab) (BLA 125522) Sponsor: AMGEN INC. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2016-07-08 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-4) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2016-07-08 FDA approved supplemental application for Repatha (evolocumab) — Efficacy (BLA 125522 S-1) Sponsor: AMGEN INC. Class: Efficacy.FDA approval (supplemental) — 2016-11-30 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-8) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2017-01-03 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-11) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2017-01-25 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-9) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2017-12-01 FDA approved supplemental application for Repatha (evolocumab) — Efficacy (BLA 125522 S-13) Sponsor: AMGEN INC. Class: Efficacy.FDA approval (supplemental) — 2017-12-01 FDA approved supplemental application for Repatha (evolocumab) — Efficacy (BLA 125522 S-14) Sponsor: AMGEN INC. Class: Efficacy.FDA approval (supplemental) — 2018-10-18 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-17) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2019-02-15 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-22) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2019-02-15 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-19) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2019-04-11 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-20) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2020-05-06 FDA approved supplemental application for Repatha (evolocumab) — Manufacturing (CMC) (BLA 125522 S-24) Sponsor: AMGEN INC. Class: Manufacturing (CMC).FDA approval — 2021-02-26 FDA approved Repatha (evolocumab) (BLA 125522) Sponsor: AMGEN INC. Class: Efficacy.FDA approval (supplemental) — 2021-09-24 FDA approved supplemental application for Repatha (evolocumab) — Efficacy (BLA 125522 S-29) Sponsor: AMGEN INC. Class: Efficacy.FDA approval (supplemental) — 2021-09-24 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-31) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2022-08-16 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-33) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2024-08-20 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-43) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2024-11-20 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-44) Sponsor: AMGEN INC. Class: Labeling.FDA approval (supplemental) — 2025-08-21 FDA approved supplemental application for Repatha (evolocumab) — Labeling (BLA 125522 S-45) Sponsor: AMGEN INC. Class: Labeling.Results posted — 2015-09-29 Trial results posted: NCT01375751 Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder StudyResults posted — 2015-09-29 Trial results posted: NCT01516879 Durable Effect of PCSK9 Antibody CompARed wiTh placEbo StudyResults posted — 2015-10-01 Trial results posted: NCT01380730 LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thEraResults posted — 2015-10-02 Trial results posted: NCT01588496 Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor AbnormalitiesResults posted — 2015-10-05 Trial results posted: NCT01375777 Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug TherResults posted — 2015-10-05 Trial results posted: NCT01652703 A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese SubjectsResults posted — 2015-10-09 Trial results posted: NCT01849497 Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/PenResults posted — 2015-10-22 Trial results posted: NCT01133522 Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults Results posted — 2015-12-22 Trial results posted: NCT01763866 LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2Results posted — 2015-12-22 Trial results posted: NCT01763918 Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2Results posted — 2015-12-22 Trial results posted: NCT01763905 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2Results posted — 2015-12-23 Trial results posted: NCT01375764 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant SubjectsResults posted — 2015-12-23 Trial results posted: NCT01953328 Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Results posted — 2015-12-23 Trial results posted: NCT01879319 Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/PenResults posted — 2015-12-30 Trial results posted: NCT01763827 Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2Results posted — 2016-01-29 Trial results posted: NCT02275156 Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of EvolocuResults posted — 2016-08-31 Trial results posted: NCT02189837 Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal AntibodyResults posted — 2017-09-19 Trial results posted: NCT02585895 Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study EnrollmentResults posted — 2018-01-04 Trial results posted: NCT01813422 GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular UltrasoundResults posted — 2018-01-16 Trial results posted: NCT02207634 Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk SubjectsResults posted — 2018-02-15 Trial results posted: NCT01764633 Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated RiskResults posted — 2018-03-13 Trial results posted: NCT01984424 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3Results posted — 2018-08-31 Trial results posted: NCT02739984 Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed DyslipidemiaResults posted — 2018-08-31 Trial results posted: NCT02634580 Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4Results posted — 2019-01-11 Trial results posted: NCT02662569 Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed DyslipidemiaResults posted — 2019-01-28 Trial results posted: NCT01624142 Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL DisordersResults posted — 2019-03-19 Trial results posted: NCT02304484 Open-label Extension (OLE) Study to Assess Safety and Efficacy of EvolocumabResults posted — 2019-04-23 Trial results posted: NCT02729025 Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated LipoprotResults posted — 2019-06-11 Trial results posted: NCT01854918 Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed DyslipidemiaResults posted — 2019-07-10 Trial results posted: NCT01439880 Open Label Study of Long Term Evaluation Against LDL-C TrialResults posted — 2020-04-03 Trial results posted: NCT03193047 Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor TherapyResults posted — 2020-07-15 Trial results posted: NCT02392559 Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric SubjectsResults posted — 2020-07-21 Trial results posted: NCT02833844 Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency VResults posted — 2020-07-24 Trial results posted: NCT03500302 Effect of Evolocumab on Coronary Endothelial FunctionResults posted — 2020-11-03 Trial results posted: NCT03403374 Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial HypercholesterolemiaResults posted — 2021-04-01 Trial results posted: NCT03331666 Impact of LDL-cholesterol Lowering on Platelet ActivationResults posted — 2021-08-20 Trial results posted: NCT03433755 Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary HypercholesteResults posted — 2021-10-11 Trial results posted: NCT02948777 Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 DiabetesResults posted — 2021-11-24 Trial results posted: NCT03570697 Imaging of Coronary Plaques in Participants Treated With EvolocumabResults posted — 2022-01-14 Trial results posted: NCT02624869 Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Results posted — 2022-02-17 Trial results posted: NCT03096288 Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet ReactivityResults posted — 2023-01-11 Trial results posted: NCT03080935 Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European CountriesResults posted — 2023-01-19 Trial results posted: NCT03258281 Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes MellitusResults posted — 2023-02-28 Trial results posted: NCT02867813 Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label ExtensionResults posted — 2023-03-08 Trial results posted: NCT03829046 The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular DiseaseResults posted — 2023-03-15 Trial results posted: NCT04573777 Reducing Intracranial atheroSclErosis With RepathaResults posted — 2023-03-24 Trial results posted: NCT03060577 An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High CholesterolResults posted — 2023-05-03 Trial results posted: NCT04710368 Effect of Evolocumab on Coronary Plaque CharacteristicsResults posted — 2024-02-16 Trial results posted: NCT03247972 Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial DiseaseResults posted — 2024-04-22 Trial results posted: NCT04189484 Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 InhibitorsResults posted — 2024-06-03 Trial results posted: NCT03944577 Impact of Evolocumab in Cardiac Transplant Patients With CAVResults posted — 2024-07-17 Trial results posted: NCT03689946 Effect of Evolocumab on Coronary AtherosclerosisResults posted — 2025-06-08 Trial results posted: NCT04992065 A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart DiResults posted — 2025-10-23 Trial results posted: NCT04082442 Evolocumab in Patients With Acute MIResults posted — 2025-11-24 Trial results posted: NCT03515304 Evolocumab in Acute Coronary SyndromeResults posted — 2026-04-16 Trial results posted: NCT04608474 Lipid Management in Renal Transplant Recipients Using Evolocumab.Results posted — 2026-05-05 Trial results posted: NCT05144529 A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLCResults posted — 2026-05-12 Trial results posted: NCT03337698 A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-SmaPivotal publication — 2014-01-01 Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 ran (JAMA) LAPLACE-2 — LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2Pivotal publication — 2015-01-01 Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. (Lancet) TESLA — Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor AbnormalitiesPivotal publication — 2016-01-01 Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. (JAMA) GAUSS-3 — Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3Pivotal publication — 2017-01-01 Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. (JAMA) GLAGOV — GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular UltrasoundPivotal publication — 2017-01-01 Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. (N Engl J Med) EVOPACS — EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS)Pivotal publication — 2017-01-01 Cognitive Function in a Randomized Trial of Evolocumab. (N Engl J Med) EBBINGHAUS — Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk SubjectsPivotal publication — 2018-01-01 Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the (Lancet) FOURIER — Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated RiskPivotal publication — 2020-01-01 Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia. (N Engl J Med) HAUSER-RCT — Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) DisordersPivotal publication — 2026-01-01 Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Tri (JAMA) VESALIUS-CV — Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or StrokePivotal publication — 2026-01-01 Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. (N Engl J Med) VESALIUS-CV — Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroketoday (2026-06-10)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Evolocumab since 2010, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (17)

2026
2025
2020
2018
2017
2016
2015
2014

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07422285
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07545226
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06284564
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal
Primary completion· ClinicalTrials.gov
NA primary completion: NCT07388420
Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis
Primary completion· ClinicalTrials.gov
Primary completion: NCT06858332
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Past events

2026
Results posted· ClinicalTrials.gov
Trial results posted: NCT03337698
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Sma
Results posted· ClinicalTrials.gov
Trial results posted: NCT05144529
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07545226
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07422285
Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose
Trial started· ClinicalTrials.gov
NA trial started: NCT07388420
Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis
2025
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT05976893
Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT05613426
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoin
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT03337698
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Sma
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT03872401
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT05613426
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoin
Results posted· ClinicalTrials.gov
Trial results posted: NCT04992065
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Di
Trial started· ClinicalTrials.gov
Trial started: NCT06858332
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
2024
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT04719221
Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patie
Primary completion· ClinicalTrials.gov
Primary completion: NCT06740552
Evolocumab in Patients With Multivessel Coronary Disease After Acute Myocardial Infarction: A Target Trial Emulation
Primary completion· ClinicalTrials.gov
Primary completion: NCT06134635
Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05144529
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06284564
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT05802108
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Primary completion· ClinicalTrials.gov
NA primary completion: NCT06364124
Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation M
Trial started· ClinicalTrials.gov
NA trial started: NCT05587621
Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
2023
Primary completion· ClinicalTrials.gov
Primary completion: NCT05974345
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Diseas
Trial started· ClinicalTrials.gov
Trial started: NCT06134635
Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
Primary completion· ClinicalTrials.gov
NA primary completion: NCT04141579
Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody
Trial started· ClinicalTrials.gov
Trial started: NCT05974345
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Diseas
Primary completion· ClinicalTrials.gov
NA primary completion: NCT05043740
PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT05976893
Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer
Trial started· ClinicalTrials.gov
NA trial started: NCT06364124
Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation M
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT03734211
Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05741086
Evolocumab Added to Statin Therapy in Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT05613426
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoin
Results posted· ClinicalTrials.gov
Trial results posted: NCT03060577
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Results posted· ClinicalTrials.gov
Trial results posted: NCT03829046
The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease
Results posted· ClinicalTrials.gov
Trial results posted: NCT02867813
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Results posted· ClinicalTrials.gov
Trial results posted: NCT03080935
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
2022
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT05661552
Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI
Primary completion· ClinicalTrials.gov
Primary completion: NCT04313270
Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04338165
Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardia
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT05585151
High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study
Primary completion· ClinicalTrials.gov
Primary completion: NCT05418166
Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT05802108
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT04100434
Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute C
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT04539223
A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04992065
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Di
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05144529
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT02867813
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT03080935
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
Results posted· ClinicalTrials.gov
Trial results posted: NCT03096288
Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity
Primary completion· ClinicalTrials.gov
Primary completion: NCT05430828
Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Results posted· ClinicalTrials.gov
Trial results posted: NCT02624869
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial
2021
Primary completion· ClinicalTrials.gov
Primary completion: NCT04087915
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)
Trial started· ClinicalTrials.gov
Trial started: NCT05418166
Impact of Evolocumab on the Antiplatelet Effects of Ticagrelor and Aspirin in Patients With Acute Coronary Syndrome
Trial started· ClinicalTrials.gov
NA trial started: NCT05043740
PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population
Results posted· ClinicalTrials.gov
Trial results posted: NCT02948777
Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT04951856
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
Results posted· ClinicalTrials.gov
Trial results posted: NCT03433755
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholeste
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04992065
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Di
Primary completion· ClinicalTrials.gov
NA primary completion: NCT04613167
Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT02624869
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04941105
Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04790513
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT04719221
Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patie
Primary completion· ClinicalTrials.gov
Phase 4 primary completion: NCT03811223
Effects of Evolocumab Versus Placebo Added to Standard Lipid-lowering Therapy on Fasting and Post Fat Load Lipids in Patients With Familial
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04338165
Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardia
Trial started· ClinicalTrials.gov
Trial started: NCT06740552
Evolocumab in Patients With Multivessel Coronary Disease After Acute Myocardial Infarction: A Target Trial Emulation
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT04100434
Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute C
2020
Primary completion· ClinicalTrials.gov
Primary completion: NCT05184530
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction
Trial started· ClinicalTrials.gov
NA trial started: NCT04613167
Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment
Trial started· ClinicalTrials.gov
NA trial started: NCT04141579
Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody
Results posted· ClinicalTrials.gov
Trial results posted: NCT03403374
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Trial started· ClinicalTrials.gov
Phase 4 trial started: NCT04659525
Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia

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.