Drugs / Evolocumab
Evolocumab
also known as
Repatha · AMG145 · Evolocumab (Repatha) · Rapatha · Repatha sureclick · Repatha; AMG 145
Monoclonal antibody targets PCSK9 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency 4 milestones | |||||
| Filed | Japan (PMDA) | Repatha | hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency | 2018-08-03 | “Amgen Astellas filed an application for supplemental indication in Japan for Repatha® SC Injection 140 mg” astellas.com ↗ |
| Filed | EU (EMA) | Repatha | hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency | 2017-06-05 | “sBLA to the U.S. Food and Drug Administration ( FDA ) and a variation to the marketing authorization to the European Medicines Agency (EMA) for Repatha ® (evolocumab)” amgen.com ↗ “In the European Union , Amgen submitted a Marketing Authorization Application to the European Medicines Agency” amgen.com ↗ |
| Filed | US (FDA) | Repatha | hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency | 2017-06-05 | “sBLA to the U.S. Food and Drug Administration ( FDA ) and a variation to the marketing authorization to the European Medicines Agency (EMA) for Repatha ® (evolocumab)” amgen.com ↗ “In the U.S., Amgen submitted a Biologics License Application for Repatha for the treatment of high cholesterol” amgen.com ↗ |
| Filed | Japan (PMDA) | Repatha | hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency | 2015-03-20 | “submitted for review to the Ministry of Health, Labour and Welfare in Japan .” amgen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | REPATHA | — | 2016-07-08 – 2021-09-24 | fda.gov ↗ |
| Approved | US (FDA) | REPATHA | — | 2015-08-27 | fda.gov ↗ |
| Approved | EU (EMA) | Repatha | — | 2015-07-17 | europa.eu ↗ |
Trials 111 · started per year
today
EU approved 2015
US approved 2015
1
5
4
9
4
1
9
5
6
13
9
12
9
5
5
6
6
2
2010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT06081153 | Dec 2026 → Jan 2029 expected | abdominal aortic aneurysm | University of Pennsylvania | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06140095 | Feb 2024 → Dec 2025 | — | Region Stockholm | Unknown | No outcome recorded |
| Phase 0 | NCT04937413 | Oct 2021 → Sep 2023 | glioblastoma | Duke University | Completed | No outcome recorded |
| Phase 0 | NCT04862260 | Oct 2021 → Jan 2025 overdue | metastatic malignant neoplasm, pancreatic ductal adenocarcinoma | CHU de Quebec-Universite Laval | Active not recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07545226 | Apr → Sep 2026 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT07422285 | Jan → Jul 2026 overdue | — | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04189484 | Jan 2020 → Apr 2021 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT02275156 | Aug → Dec 2014 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01133522 | Jun 2010 → Sep 2011 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04101643 | Sep 2019 → Jan 2023 | hereditary spastic paraplegia 5A | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 218 trials · 6 met primary | ||||||
| Phase 2 | NCT07301372 | Oct 2025 → Mar 2026 | stroke disorder | The Affiliated Hospital of Xuzhou Medical University | Completed | No outcome recorded |
| Phase 2 | NCT06496243 | Dec 2024 → Nov 2026 expected | hyperlipidemia | NewAmsterdam Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT06284564 | Aug 2024 → Oct 2026 expected | renal cell carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05144529 | Mar 2022 → Sep 2024 | lung cancer | Eziafa Oduah, MD, PhD, MPH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04338165 | Jan 2021 → Nov 2022 | atherosclerotic cardiovascular disease | University Hospital, Grenoble | Unknown | No outcome recorded |
| Phase 2 | NCT04303377 | Nov 2019 → Jan 2020 | ST-elevation myocardial infarction | Fondazione IRCCS Policlinico San Matteo di Pavia | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04082442 | Sep 2019 → Oct 2024 | acute coronary syndrome | Johns Hopkins University | Completed | Met primary |
| Phase 2 | NCT03944577 | Jul 2019 → Mar 2023 | — | University of Nebraska | Completed | No outcome recorded |
| Phase 2 | NCT03869073 | Feb 2019 → Feb 2021 | infectious disease with sepsis | University of British Columbia | Unknown | No outcome recorded |
| Phase 2 | NCT03791593 | Dec 2018 → Jun 2021 | symptomatic heart failure | Germans Trias i Pujol Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT03515304 | May 2018 → Oct 2024 | acute coronary syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT03500302 | May 2018 → Nov 2019 | HIV infectious disease, coronary artery disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT01652703 | Jul 2012 → May 2013 | hyperlipoproteinemia | Amgen | Completed | Met primary |
| Phase 2 | NCT01439880 | Oct 2011 → Jun 2018 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01375751 | Aug 2011 → May 2012 | familial hypercholesterolemia | Amgen | Completed | Met primary |
| Phase 2 | NCT01375764 | Jul 2011 → May 2012 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 2 | NCT01375777 | Jul 2011 → Mar 2012 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 2 | NCT01380730 | Jul 2011 → Apr 2012 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 2/34 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07174375 | Sep 2025 → Dec 2027 expected | ischemic stroke | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06696820 | Nov 2024 → Mar 2026 | ischemic stroke | Xiang Luo | Completed | No outcome recorded |
| Phase 2/3 | NCT01624142 | Jun 2012 → May 2018 | familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 2/3 | NCT01588496 | Apr 2012 → Jan 2014 | homozygous familial hypercholesterolemia | Amgen | Completed | Met primary |
| Phase 332 trials · 22 met primary · 2 missed | ||||||
| Phase 3 | NCT04968509 | Mar 2024 → Dec 2027 expected | aortic valve stenosis | Beijing Anzhen Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05741086 | Apr 2023 → Aug 2024 | cerebral artery stenosis | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT04941105 | Jun 2021 → May 2022 | COVID-19 | Collegium Medicum w Bydgoszczy | Completed | Met primary |
| Phase 3 | NCT06081803 | Dec 2020 → Dec 2025 overdue | ST-elevation myocardial infarction | Sejong General Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03872401 | Jun 2019 → Jul 2025 | coronary artery disorder | Amgen | Completed | Met primary |
| Phase 3 | NCT03734211 | Jun 2019 → May 2023 | — | Lars Gullestad | Completed | Missed primary |
| Phase 3 | NCT03433755 | May 2019 → Apr 2020 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Amgen | Terminated | Met primary |
| Phase 3 | NCT03689946 | Mar 2019 → Jan 2023 | cardiovascular disorder, hyperlipidemia | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT03570697 | Nov 2018 → Dec 2020 | coronary artery disorder | Amgen | Completed | Met primary |
| Phase 3 | NCT02833844 | May 2017 → Jul 2019 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT03080935 | Mar 2017 → Mar 2022 | hyperlipidemia | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02624869 | Sep 2016 → Jun 2021 | familial hypercholesterolemia | Amgen | Completed | Met primary |
| Phase 3 | NCT02867813 | Sep 2016 → Mar 2022 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02739984 | May 2016 → Aug 2017 | hyperlipidemia, combined, 2, type 2 diabetes mellitus | Amgen | Completed | Met primary |
| Phase 3 | NCT02729025 | Apr 2016 → Apr 2018 | hyperlipidemia | Amgen | Completed | Missed primary |
| Phase 3 | NCT02662569 | Apr 2016 → Dec 2017 | hyperlipidemia, combined, 2 | Amgen | Completed | Met primary |
| Phase 3 | NCT02392559 | Mar 2016 → Nov 2019 | familial hypercholesterolemia | Amgen | Completed | Met primary |
| Phase 3 | NCT02634580 | Feb 2016 → Aug 2017 | hyperlipoproteinemia | Amgen | Completed | Met primary |
| Phase 3 | NCT02585895 | Dec 2015 → Sep 2016 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT02304484 | Nov 2014 → Mar 2018 | hyperlipidemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02207634 | Sep 2014 → Nov 2016 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT02189837 | Jul 2014 → Feb 2015 | hyperlipidemia, combined, 2 | Amgen | Completed | Met primary |
| Phase 3 | NCT01984424 | Dec 2013 → Nov 2015 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01953328 | Oct 2013 → Jun 2014 | hyperlipidemia, combined, 2 | Amgen | Completed | Met primary |
| Phase 3 | NCT01854918 | Apr 2013 → May 2018 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01813422 | Apr 2013 → Jul 2016 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01764633 | Feb 2013 → Nov 2016 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01763918 | Feb → Nov 2013 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01763905 | Jan → Nov 2013 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01763827 | Jan → Oct 2013 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01763866 | Jan → Nov 2013 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 3 | NCT01516879 | Jan 2012 → Oct 2013 | hyperlipoproteinemia | Amgen | Completed | Met primary |
| Phase 435 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT07803679 | Jan 2027 → Apr 2029 expected | atherosclerosis, coronary artery disorder, hyperlipidemia | Amgen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07819643 | Jan 2027 → Jan 2029 expected | carotid stenosis, cerebral atherosclerosis | Keqiang Zhao | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07295366 | Dec 2025 → May 2026 | stroke disorder | The Affiliated Hospital of Xuzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT07612774 | Nov 2025 → Oct 2028 expected | coronary atherosclerosis | West China Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07084259 | Jul 2025 → Jun 2030 expected | coronary artery disorder | Hanyang University Seoul Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05976893 | Aug 2023 → Dec 2025 | atherosclerotic cardiovascular disease, cancer | Xiang Xie | Unknown | No outcome recorded |
| Phase 4 | NCT05613426 | Apr 2023 → Jul 2025 | ST-elevation myocardial infarction | Henan Institute of Cardiovascular Epidemiology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05697185 | Feb 2023 → Feb 2024 | ischemic stroke | Second Affiliated Hospital of Guangxi Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05623995 | Dec 2022 → Dec 2024 | coronary restenosis | Lin Zhao | Unknown | No outcome recorded |
| Phase 4 | NCT05641753 | Dec 2022 → Jul 2027 expected | type 1 diabetes mellitus | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 4 | NCT05661552 | Dec 2022 → Feb 2025 | hyperlipoproteinemia | Yonsei University | Completed | Met primary |
| Phase 4 | NCT05585151 | Nov 2022 → Apr 2024 | cerebral atherosclerosis | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 4 | NCT05284747 | Oct 2022 → May 2027 expected | coronary artery disorder, myocardial infarction, stroke disorder | Amgen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05802108 | Jul 2022 → Jun 2024 | — | Zibo Central Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05152888 | Mar 2022 → Mar 2027 expected | coronary artery disorder | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04951856 | Sep 2021 → May 2026 overdue | ST-elevation myocardial infarction | Assistance Publique - Hôpitaux de Paris | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04710368 | May 2021 → Oct 2022 | coronary atherosclerosis | Annapoorna Kini | Completed | No outcome recorded |
| Phase 4 | NCT04573777 | Apr → Dec 2021 | ischemic stroke | University of California, Los Angeles | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04510844 | Mar → Oct 2021 | chronic kidney disease | NYU Langone Health | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04608474 | Feb 2021 → Jan 2024 | hyperlipidemia | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04100434 | Jan 2021 → Jun 2022 | acute coronary syndrome | Tianjin Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04659525 | Nov 2020 → Nov 2021 | end stage renal failure, hyperlipidemia | Policlinico Casilino ASL RMB | Unknown | No outcome recorded |
| Phase 4 | NCT04369664 | Aug 2020 → Sep 2023 | type 2 diabetes mellitus | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT04397653 | May → Nov 2020 | end stage renal failure, hyperlipoproteinemia | Policlinico Casilino ASL RMB | Unknown | No outcome recorded |
| Phase 4 | NCT04306471 | Feb 2020 → Feb 2021 | limb ischemia | Leonardo Clavijo | Unknown | No outcome recorded |
| Phase 4 | NCT03851263 | Aug 2019 → Aug 2021 | coronary atherosclerosis | ECRI bv | Withdrawn | No outcome recorded |
| Phase 4 | NCT03811223 | Aug 2019 → Jan 2021 | hyperlipoproteinemia type 3 | UMC Utrecht | Unknown | No outcome recorded |
| Phase 4 | NCT03900026 | May 2019 → Jan 2025 | atherosclerosis, vascular occlusion disorder | Unity Health Toronto | Completed | Missed primary |
| Phase 4 | NCT06231459 | Jan 2019 → Dec 2020 | familial hypercholesterolemia | Institute for Social Security and Services for State Workers | Completed | No outcome recorded |
| Phase 4 | NCT03753555 | Dec 2018 → Nov 2027 expected | cerebral atherosclerosis, ischemic stroke | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| Phase 4 | NCT03403374 | Aug 2018 → Nov 2019 | homozygous familial hypercholesterolemia | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT04306081 | Dec 2017 → Dec 2020 | peripheral arterial disease | Leonardo Clavijo | Unknown | No outcome recorded |
| Phase 4 | NCT03096288 | Oct 2017 → Nov 2020 | atherosclerotic cardiovascular disease | University of Florida | Completed | Missed primary |
| Phase 4 | NCT02948777 | Oct 2016 → Jun 2018 | type 2 diabetes mellitus | Marja-Riitta Taskinen | Completed | Mixed |
| Phase 4 | NCT02941016 | Oct 2016 → Oct 2020 | combined low LDL and fibrinogen | Rigshospitalet, Denmark | Withdrawn | No outcome recorded |
| Phase not applicable11 trials · 1 missed | ||||||
| — | NCT07704918 | Dec 2026 → Dec 2027 expected | melanoma | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| — | NCT07388420 | Jan → Dec 2026 expected | acute pancreatitis | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT06791031 | Jan 2026 → Dec 2027 expected | coronary atherosclerosis | West China Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06730802 | Jan 2025 → Dec 2026 expected | coronary artery disorder, myocardial ischemia | Nanjing Medical University | Not yet recruiting | No outcome recorded |
| — | NCT06364124 | Jun 2023 → Jun 2024 | ST-elevation myocardial infarction | Beijing Luhe Hospital | Unknown | No outcome recorded |
| — | NCT05624658 | Sep 2022 → May 2024 | hyperlipidemia | Samara Regional Cardiology Dispensary | Unknown | No outcome recorded |
| — | NCT05043740 | Oct 2021 → Oct 2023 | acute coronary syndrome | Second Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| — | NCT04730648 | Apr 2021 → Apr 2022 | cardiovascular disorder | Shenzhen People's Hospital | Unknown | No outcome recorded |
| — | NCT04141579 | Nov 2020 → Nov 2023 | coronary atherosclerosis | Radboud University Medical Center | Completed | Missed primary |
| — | NCT04613167 | Nov 2020 → Jun 2021 | acute coronary syndrome, coronary artery disorder, hyperlipoproteinemia | University Medical Centre Ljubljana | Unknown | No outcome recorded |
| — | NCT04314167 | Jul 2020 → Mar 2024 | hyperlipidemia | University Hospital Tuebingen | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy27 trials | ||||||
| Phase 1 | NCT07286110 Background | Dec 2025 → Nov 2026 expected | Moyamoya disease | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06700720 Background | Feb → Jul 2026 | coronary atherosclerosis | Beijing Inno Medicine Co., Ltd. | Terminated | No outcome recorded |
| Phase 2 | NCT04992065 Comparator | Aug 2021 → Apr 2022 | atherosclerotic cardiovascular disease | Novo Nordisk A/S | Completed | Met primary |
| Phase 2 | NCT03060577 Comparator | Apr 2017 → Dec 2021 | atherosclerotic cardiovascular disease, familial hypercholesterolemia, type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03193047 Background | Apr 2017 → Jan 2018 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT04790513 Comparator | Apr 2021 → Sep 2022 | cardiovascular disorder, hyperlipidemia | LIB Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT04034485 Comparator | Dec 2019 → Sep 2022 | homozygous familial hypercholesterolemia | LIB Therapeutics LLC | Completed | Missed primary |
| Phase 3 | NCT04665830 Comparator | May 2018 → May 2020 | — | Hamid Al-Essa Organ Transplant Center | Completed | No outcome recorded |
| Phase 3 | NCT03287609 Comparator | Jan 2018 → May 2019 | acute coronary syndrome | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 3 | NCT03429998 Comparator | Apr 2017 → Jan 2018 | familial hypercholesterolemia | Hospital General Universitario Gregorio Marañon | Completed | No outcome recorded |
| Phase 3 | NCT01879319 Background | Jul → Nov 2013 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01849497 Background | Apr → Sep 2013 | hyperlipidemia, combined, 2 | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT06381947 Background | May 2024 → Jun 2025 | cardiovascular disorder, cholesterol metabolism disease, hyperlipidemia, statin toxicity | University of Salerno | Unknown | No outcome recorded |
| Phase 4 | NCT05579418 Comparator | Nov 2022 → Oct 2024 | ST-elevation myocardial infarction, hyperlipidemia | Hamad Medical Corporation | Unknown | No outcome recorded |
| Phase 4 | NCT05537948 Comparator | Oct 2021 → Jan 2024 overdue | hyperlipidemia, liver disorder | National Medical Research Center for Therapy and Preventive Medicine | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04719221 Comparator | Mar 2021 → Dec 2024 | acute coronary syndrome | Korea University Anam Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04730973 Comparator | Mar 2021 → Mar 2022 | carotid artery disorder | Azienda Ospedaliera Ordine Mauriziano di Torino | Unknown | No outcome recorded |
| Phase 4 | NCT04539223 Comparator | Aug 2020 → Apr 2022 | carotid stenosis | Canadian Medical and Surgical Knowledge Translation Research Group | Unknown | No outcome recorded |
| Phase 4 | NCT04073134 Comparator | Sep 2019 → Mar 2022 | atherosclerosis, coronary artery disorder, hyperlipidemia | Imperial College London | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03931161 Comparator | Sep 2019 → May 2023 | carotid stenosis | Imperial College Healthcare NHS Trust | Unknown | No outcome recorded |
| Phase 4 | NCT03829046 Comparator | Jun 2019 → Nov 2021 | atherosclerotic cardiovascular disease, type 2 diabetes mellitus, vascular insufficiency disorder | Robert Rosenson | Completed | No outcome recorded |
| Phase 4 | NCT03626831 Comparator | Apr 2019 → Apr 2021 | atherosclerotic cardiovascular disease | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 4 | NCT03331666 Comparator | Nov 2018 → Feb 2020 | familial hypercholesterolemia | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT03932721 Comparator | Oct 2018 → Jun 2021 | hypertensive disorder, type 2 diabetes mellitus | University of Campinas, Brazil | Completed | No outcome recorded |
| Phase 4 | NCT03258281 Comparator | May 2018 → Sep 2019 | type 2 diabetes mellitus | Inova Health Care Services | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT05587621 Comparator | Apr 2024 → Apr 2026 overdue | ST-elevation myocardial infarction, low density lipoprotein cholesterol, mild elevation of | Jena University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT04656028 Background | Jun 2020 → Jan 2025 overdue | defective apolipoprotein b-100, hypercholesterolemia, autosomal dominant, 3, hypercholesterolemia, autosomal dominant, type B, hypercholesterolemia, familial, 1 +1 | National Medical Research Center for Therapy and Preventive Medicine | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 62
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Amgen | Results AMGEN'S REPATHA® REDUCES RISK OF DEATH IN PATIENTS AT HIGH RISK FOR A FIRST HEART ATTACK OR STROKE amgen.com ↗
Amgen (NASDAQ: AMGN) today announced new findings showing Repatha ® (evolocumab) reduced the risk of death in high-risk adults without a prior heart attack or stroke when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments. |
| 2026-07-29 | Amgen | Regulatory POSITIVE CHMP OPINION SUPPORTS BROADER USE OF AMGEN'S REPATHA® BEFORE A FIRST HEART ATTACK OR STROKE amgen.com ↗
Amgen (NASDAQ: AMGN ) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Repatha ® (evolocumab) for adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors. |
| 2026-06-07 | Amgen | Results AMGEN PRESENTS NEW DATA ACROSS ITS CARDIOMETABOLIC PORTFOLIO AT AMERICAN DIABETES ASSOCIATION 86TH SCIENTIFIC SESSIONS amgen.com ↗
Repatha also reduced the risk of a second composite primary endpoint that included ischemia-driven revascularization (4-P MACE) by 21%. |
| 2026-03-28 | Amgen | Results REPATHA® CUTS RISK OF FIRST MAJOR CARDIOVASCULAR EVENTS BY 31% IN HIGH-RISK PATIENTS WITHOUT KNOWN SIGNIFICANT ATHEROSCLEROSIS amgen.com ↗
Results showed Repatha reduced the risk of the composite primary endpoint of coronary heart disease (CHD) death, myocardial infarction or ischemic stroke (3‑P MACE) by 31% compared with placebo. |
| 2025-11-08 | Amgen | Results AMGEN'S REPATHA® CUTS RISK OF FIRST MAJOR ADVERSE CARDIOVASCULAR EVENTS BY 25% IN LANDMARK PHASE 3 VESALIUS-CV TRIAL amgen.com ↗
Repatha also reduced the risk of heart attack by 36%. |
| 2025-10-02 | Amgen | Results LANDMARK PHASE 3 TRIAL (VESALIUS-CV) MEETS PRIMARY ENDPOINTS IN A CARDIOVASCULAR PRIMARY PREVENTION STUDY OF 12,000 PATIENTS amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha ® (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke. |
| 2025-08-25 | Amgen | Regulatory REPATHA® NOW INDICATED FOR ADULTS AT INCREASED RISK FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS DUE TO UNCONTROLLED LDL-C amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha ® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' |
| 2023-11-10 | Amgen | Results AMGEN PRESENTS NEW CARDIOVASCULAR RESEARCH AT AHA 2023 amgen.com ↗
The data showed patients treated with Repatha did not experience any apparent cognitive decline following a median achieved LDL-C of 34 mg/dL through a median follow-up period of 5.1 years. |
| 2023-03-01 | Amgen | Results AMGEN TO PRESENT NEW REPATHA® (EVOLOCUMAB) AND OLPASIRAN DATA AT ACC amgen.com ↗
These findings showed that over the duration of follow-up, patients with atherosclerotic cardiovascular disease (ASCVD) who were already receiving statin therapy had a reduction in adverse cardiovasclar outcomes with earlier initiation of Repatha. |
| 2022-11-07 | Amgen | Results AMGEN PRESENTS NEW REPATHA® (EVOLOCUMAB) DATA AT AHA 2022 amgen.com ↗
The current analysis further supports that achieving very low LDL-C long-term is not associated with any new safety signals and correlates with the reduction in cardiovascular events in patients with atherosclerotic cardiovascular disease, |
| 2022-09-02 | Amgen | Results 2022年欧州心臓病学会学術集会でREPATHA® (EVOLOCUMAB) が8年以上の長期間LDL-C低下作用を示すとともに、忍容性も確認された結果が発表される amgen.co.jp ↗
FOURIER-OLE試験では、Repathaにより、低比重リポ蛋白コレステロール（LDL-C）値が医学的に有意かつ持続的に低下し、80%の患者でLDL-C値が 55 mg/dL未満を達成しました1。 |
| 2022-08-29 | Amgen | Results NEW AMGEN DATA AT ESC 2022 SHOW LONG-TERM LDL-C LOWERING WITH REPATHA® (EVOLOCUMAB) WAS WELL-TOLERATED FOR MORE THAN 8 YEARS amgen.com ↗
The OLE studies showed Repatha delivered medically significant and sustained reduction in low-density lipoprotein cholesterol (LDL-C) levels, with 80% of patients achieving a low-density lipoprotein cholesterol (LDL-C) level of <55mg/dL. |
| 2022-04-27 | Amgen | Results AMGEN ANNOUNCES RESULTS FROM TWO OPEN LABEL EXTENSION STUDIES OF REPATHA® (EVOLOCUMAB) amgen.com ↗
Both studies showed that Repatha, administered at 140 mg every two weeks or 420 mg monthly, was safe and well-tolerated. |
| 2021-09-25 | Amgen | Regulatory FDA Approves Repatha® (evolocumab) In Pediatric Patients Age 10 And Older With Heterozygous Familial Hypercholesterolemia amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Repatha ® (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C. |
| 2021-08-27 | Amgen | Results New Data At ESC Congress 2021 Shows Repatha® (evolocumab) Improves Features Of Plaque Stability In Patients With Acute Coronary Syndrome (ACS) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive data from the HUYGENS Phase 3 study showing that Repatha ® (evolocumab) in addition to optimized statin therapy, in comparison with optimized statin therapy alone, significantly improved features of plaque stability in patients with coronary artery disease (CAD). |
| 2021-05-11 | Amgen | Results Efficacy Of Repatha® (Evolocumab) Across High-Risk Patient Populations Reinforced At ACC.21 amgen.com ↗
The data in HIV confirm the safety and efficacy of Repatha across different patient populations and contribute to Amgen 's PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations) program of clinical and real-world evidence studies investigating the impact of Repatha on cardiovascular disease. |
| 2020-08-29 | Amgen | Results Amgen Announces Positive Data From Phase 3B Study Of Repatha® (Evolocumab) In Pediatric Patients With Heterozygous Familial Hypercholesterolemia At ESC Congress 2020 amgen.com ↗
The study showed that Repatha, in combination with statins and other lipid-lowering therapies, significantly reduced low-density lipoprotein cholesterol (LDL-C) compared to placebo. |
| 2020-03-28 | Amgen | Results Amgen Announces Positive Results At ACC.20/WCC From Phase 3B Study Of Repatha® (Evolocumab) In People Living With HIV Who Have High LDL-Cholesterol amgen.com ↗
The study demonstrated that treatment with Repatha significantly reduced LDL-C. |
| 2019-11-16 | Amgen | Results Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack amgen.com ↗
In the analysis, the risk reduction for experiencing a heart attack, stroke or CV death, in Repatha-treated patients treated within one year post MI was 25% compared to 15% in those patients with a more distant MI. |
| 2019-06-18 | Astellas Pharma Inc | Regulatory HYPERCHOLESTEROLEMIA DRUG REPATHA® SC INJECTION RECEIVES SUPPLEMENTAL INDICATION APPROVAL AS MONOTHERAPY FOR TREATING HYPERCHOLESTEROLEMIA PATIENTS NOT SUITABLE FOR STATIN THERAPY astellas.com ↗
The approval for the supplemental indication will make it possible for Repatha® to be used alone in familial hypercholesterolemia or hypercholesterolemia patients for whom statin therapy is not suitable, due to a history of side effects or contraindication. |
| 2019-01-24 | Amgen | Regulatory Amgen Receives NMPA Approval For Repatha® (evolocumab) In China To Reduce The Risk Of Cardiovascular Events amgen.com ↗ |
| 2018-11-12 | Amgen | Results Amgen Presents Results Highlighting The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In The Longest Duration Study Of A PCSK9 Inhibitor To Date At AHA Scientific Sessions 2018 amgen.com ↗
Patients treated with Repatha achieved a 59 percent reduction in mean LDL-C from baseline during the first year of treatment (n=785). |
| 2018-10-26 | Amgen | Results Amgen Announces New FOURIER Analysis Showing Benefit With Repatha® (Evolocumab) In High-Risk Patients With Established Cardiovascular Disease And Chronic Kidney Disease amgen.com ↗
In these patients (N=4,443), absolute reductions tended to be greater in the risk for the composite secondary endpoint which included cardiovascular death, heart attack or stroke. |
| 2018-08-03 | Astellas Pharma Inc | Regulatory Application for Supplemental Indication Filed for Hypercholesterolemia Drug Repatha® SC Injection in Treating Statin-intolerant Patients astellas.com ↗
The application for supplemental indication was filed on the basis of the outcomes of the Phase 3 randomized study Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 (GAUSS-4) enrolling statin intolerant Japanese subjects. |
| 2018-06-23 | Amgen | Results New Data Show Amgen's Repatha® (evolocumab) Significantly Reduced LDL-C And Non-HDL-C In High-risk Patients With Type 2 Diabetes amgen.com ↗
The findings of the BANTING study clearly demonstrate the ability for Repatha to help these patients reach their targets. |
| 2018-05-16 | Amgen | Regulatory Amgen Receives European Commission Approval For Repatha® (Evolocumab) To Prevent Heart Attack And Stroke In Adults With Established Cardiovascular Disease amgen.com ↗ |
| 2018-03-23 | Amgen | Regulatory Amgen Receives Positive CHMP Opinion Recognizing That Repatha® (evolocumab) Prevents Heart Attacks And Strokes amgen.com ↗ |
| 2017-12-01 | Amgen | Regulatory FDA Approves Amgen's Repatha® (evolocumab) To Prevent Heart Attack And Stroke amgen.com ↗ |
| 2017-11-13 | Amgen | Results New Analyses Presented At AHA 2017 Show Repatha® (evolocumab) Significantly Reduced Cardiovascular Events In Patients With Peripheral Artery Disease And In Patients With A History Of Heart Attacks amgen.com ↗
One analysis showed the addition of Repatha to statin therapy improved clinical outcomes with significant reduction of CV events in patients with a history of PAD. |
| 2017-09-15 | Amgen | Results New FOURIER Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events In Patients With Diabetes amgen.com ↗
Patients with diabetes tended to have a greater absolute risk reduction of cardiovascular events with Repatha treatment because of their heightened baseline risk. |
| 2017-08-29 | Amgen | Results New Virtual Histology Sub-Study Evaluates Impact Of Repatha® (Evolocumab) On Coronary Artery Plaque Composition amgen.com ↗
Amgen (NASDAQ:AMGN) today announced results from an exploratory virtual histology sub-study of the Repatha ® (evolocumab) GLAGOV Phase 3 coronary intravascular ultrasound imaging trial that looked at coronary artery plaque composition. |
| 2017-08-29 | Amgen | Results New Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events In Patients With History Of Stroke amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that a new analysis showed lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha ® (evolocumab) reduced the risk of cardiovascular events in a sub-group of patients with a history of stroke from the Repatha cardiovascular outcomes study (FOURIER). |
| 2017-08-28 | Amgen | Results New Repatha® (evolocumab) Analysis Demonstrates Cardiovascular Outcomes Efficacy And Safety Of Achieving Very Low LDL-C Levels amgen.com ↗
Amgen (NASDAQ:AMGN) today announced a new analysis from the Repatha ® (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease. |
| 2017-08-23 | Amgen | Results New Economic Analysis Based On Repatha® (Evolocumab) Outcomes Data Published In JAMA Cardiology amgen.com ↗
Repatha was found to be a cost-effective treatment for patients with established ASCVD in the U.S. when the net price is at or below $9,669 per year. |
| 2017-08-16 | Amgen | Results Repatha® (Evolocumab) Phase 3 Cognitive Function Study Results Published In The New England Journal Of Medicine amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the New England Journal of Medicine ( NEJM ) published results from the Repatha ® (evolocumab) cognitive function trial (EBBINGHAUS), which was conducted in a subset of patients enrolled in the randomized, placebo-controlled Repatha cardiovascular outcomes study (FOURIER). |
| 2017-07-27 | Amgen | Regulatory FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha ® (evolocumab), a PCSK9 inhibitor. |
| 2017-06-05 | Amgen | Regulatory Amgen Submits Regulatory Applications For Repatha® (evolocumab) Cardiovascular Outcomes Data In US And Europe amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ( FDA ) and a variation to the marketing authorization to the European Medicines Agency (EMA) for Repatha ® (evolocumab), a PCSK9 inhibitor. |
| 2017-05-20 | Amgen | Results Repatha® (Evolocumab) Reduced Cardiovascular Events In Patients With Baseline LDL-C Levels Below Current Targets amgen.com ↗
A separate analysis also demonstrated Repatha reduced cardiovascular events in patients being treated with maximum-intensity statin therapy. |
| 2017-03-19 | Amgen | Results Analyses Of PCSK9 Inhibitor Prescription Rejection Rates Demonstrate Significant Access Barriers For Appropriate Patients amgen.com ↗ |
| 2017-03-18 | Amgen | Results Lowering LDL Levels With Repatha® (Evolocumab) Did Not Adversely Affect Cognitive Function In Landmark Phase 3 Study amgen.com ↗
The study demonstrated that the effect of Repatha on the primary endpoint of executive function was non-inferior to placebo. |
| 2017-03-17 | Amgen | Results Landmark Outcomes Study Shows That Repatha® (Evolocumab) Decreases LDL-C To Unprecedented Low Levels And Reduces Risk Of Cardiovascular Events With No New Safety Issues amgen.com ↗
Patients on Repatha experienced a reduction in the risk of heart attack (27 percent, nominal p <0.001), stroke (21 percent, nominal p =0.01) and coronary revascularization (22 percent, nominal p <0.001). |
| 2017-03-14 | Amgen | Results Repatha® (Evolocumab) Four-Year Open-Label Follow-Up Study Published In 'JAMA Cardiology' amgen.com ↗
Repatha, when added to standard of care (SOC), achieved median low-density lipoprotein cholesterol (LDL-C) reductions of 57 percent at four years, with no new safety concerns identified and no neutralizing antibodies observed with cumulative exposure. |
| 2017-03-13 | Amgen | Results Repatha® (Evolocumab) Demonstrates Reduced Need For Apheresis In Patients With High LDL Cholesterol In Phase 3 Study amgen.com ↗
The study met its primary endpoint, demonstrating that treatment with Repatha significantly reduced the need for LDL-C apheresis in adult patients, as measured at the end of the randomized period. |
| 2017-02-21 | Amgen | Regulatory Repatha® (Evolocumab) Receives European Commission Approval For New 420 mg Single-Dose Delivery Option amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has adopted a decision to change the Repatha ® (evolocumab) marketing authorization, approving a new single-dose delivery option. |
| 2017-02-02 | Amgen | Results Amgen Reports Fourth Quarter And Full Year 2016 Financial Results amgen.com ↗
We anticipate several new product development opportunities and launches in 2017, and are excited about the Repatha cardiovascular outcomes data we released today. |
| 2017-02-02 | Amgen | Results Amgen Announces Repatha® (Evolocumab) Significantly Reduced The Risk Of Cardiovascular Events In FOURIER Outcomes Study amgen.com ↗ |
| 2016-12-16 | Amgen | Regulatory New Repatha® (evolocumab) Dose Delivery Option Receives Positive CHMP Opinion amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha ® (evolocumab). |
| 2016-11-15 | Amgen | Results Repatha® (Evolocumab) Regresses Atherosclerosis In Patients With Coronary Artery Disease amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that adding Repatha ® (evolocumab) to optimized statin therapy resulted in statistically significant regression of atherosclerosis in patients with coronary artery disease (CAD). |
| 2016-09-20 | Amgen | Results Amgen Announces Positive Top-Line Results From Phase 3 GLAGOV Imaging Study Of Repatha® (Evolocumab) amgen.com ↗ |
| 2016-08-28 | Amgen | Results New Repatha® (evolocumab) Analyses Show Efficacy And Safety Across Risk Groups In Results Presented At ESC Congress 2016 amgen.com ↗
Amgen (NASDAQ:AMGN) today announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha ® (evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (FH). |
| 2016-07-11 | Amgen | Regulatory FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the Repatha ® (evolocumab) Pushtronex ™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. |
| 2016-04-03 | Amgen | Results Positive Efficacy And Tolerability Study Of Repatha® (evolocumab) In Statin-Intolerant Patients Published In Journal of the American Medical Association amgen.com ↗
The study showed that in patients with reproducible statin intolerance due to muscle-related side effects (MRSE), the use of Repatha compared to ezetimibe resulted in a significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) after 24 weeks. |
| 2016-02-04 | Amgen | Results Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha® (Evolocumab) In Statin-Intolerant Patients With High Cholesterol amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Phase 3 GAUSS-3 ( G oal A chievement After U tilizing an Anti-PCSK9 Antibody in S tatin Intolerant S ubjects-3) trial evaluating Repatha ® (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. |
| 2016-01-22 | Amgen | Regulatory Amgen's Repatha® (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha ® (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan . |
| 2015-09-11 | Amgen | Regulatory Amgen Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha™ (Evolocumab) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the submission of an application to the U.S. Food and Drug Administration ( FDA ) seeking approval of a single-dosing option for the monthly administration of Repatha TM (evolocumab) Injection, allowing the 420 mg monthly dose to be administered as a single injection. |
| 2015-08-27 | Amgen | Regulatory FDA Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved a new cholesterol-lowering medication, Repatha ™ (evolocumab) Injection. |
| 2015-07-21 | Amgen | Regulatory European Commission Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for Repatha ™ (evolocumab), the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction. |
| 2015-05-22 | Amgen | Regulatory Amgen Receives Positive CHMP Opinion For Use Of Repatha™ (Evolocumab) For The Treatment Of High Cholesterol amgen.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Repatha ™ (evolocumab) |
| 2015-03-20 | Amgen | Regulatory Amgen Submits Application For Investigational LDL Cholesterol-Lowering Medication Repatha™ (evolocumab) In Japan amgen.com ↗
Amgen (NASDAQ: AMGN) today announced that an application seeking marketing approval of Repatha TM (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan . |
| 2015-03-15 | Amgen | Results Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha™ (evolocumab) In The New England Journal of Medicine amgen.com ↗
Data from prespecified exploratory endpoints in the ongoing open-label OSLER-1 and OSLER-2 studies showed Repatha plus standard of care (SOC) treatment reduced adjudicated cardiovascular events (0.95 percent Repatha plus SOC; 2.18 percent SOC) over a one-year analysis period. |
| 2015-03-14 | Amgen | Results New Detailed Data From Phase 3 Study Show Amgen's Repatha™ (Evolocumab) In Combination With Statins Reduced LDL-C By 67-76 Percent Compared To Placebo In Japanese Patients With High Cardiovascular Risk And High Cholesterol amgen.com ↗
Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 YUKAWA-2 study evaluating Repatha™ (evolocumab), a novel investigational cholesterol-lowering medication, in Japanese patients with high cardiovascular risk and high cholesterol. |
| 2014-11-18 | Amgen | Results Amgen Presents Long-Term Data Showing Efficacy And Safety Of Investigational Cholesterol-Lowering Medication Evolocumab Across Lipid And LDL-C Levels amgen.com ↗
Data from one of the long-term pooled analyses showed that evolocumab significantly reduced lipoprotein(a) (Lp(a)) over 64 weeks. |
All press releases naming this drug 93 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 140 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Evolocumab | “Patients randomized to the "PCSK9i early" intensified therapy group will receive initial treatment with a PCSK9 inhibitor-either evolocumab 140 mg or alirocumab 75 mg, both...” NCT06791031 ↗136“Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after...” NCT07174375 ↗ “This study sought to evaluate the ability of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab to reduce the risk of complex coronary...” PMID 33197560 ↗ Nov 2020 “Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label...” NCT05624658 ↗ “Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%.” PMID 28304224 ↗ Mar 2017 “A combination of a lipophilic statin (Atorvastatin, Lipitor), a NPC1L1 inhibitor (Ezetimibe, Ezetrol) and a PCSK9 inhibitor (Evolocumab, Repatha) with chemotherapy in pancreatic cancer” NCT04862260 ↗ “Patients in experimental group are treated with PCSK9 inhibitors (140mg with Evolocumab or 75mg with Alirocumab or 150mg with Tafolecimab subcutaneously every two weeks)” NCT04968509 ↗ “Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months” NCT05043740 ↗ “In case of intolerance to all drugs from the statin group, the patient will be prescribed ezetimibe with a PCSK9 inhibitor (alirocumab / evolocumab).” NCT04656028 ↗ “The patients with ACS received one dose of subcutaneous evolocumab (140 mg) on top of 10 mg/day rosuvastatin during hospitalization.” PMID 36017088 ↗ Aug 2022 “PCSK9 inhibitors (Evolocumab 140 mg or Alirocumab 75 mg or Alirocumab 150 mg) plus Ezetimibe 10 mg plus Bempedoic acid (Treatment A)” NCT06381947 ↗ |
| Known as | AMG145 | “Evolocumab (also known as Repatha, formerly referred to as AMG 145) is a human monoclonal immunoglobulin G2 (IgG2) that specifically binds to proprotein convertase...” NCT04141579 ↗2“A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia” NCT01624142 ↗ “evolocumab (AMG 145)” NCT02867813 ↗ |
| Known as | Evolocumab (Repatha) | “Evolocumab (Repatha)” NCT07084259 ↗ |
| Known as | Rapatha | “Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel...” NCT03331666 ↗ |
| Known as | Repatha | “REPATHA (evolocumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); it will be...” NCT03900026 ↗14“A combination of a lipophilic statin (Atorvastatin, Lipitor), a NPC1L1 inhibitor (Ezetimibe, Ezetrol) and a PCSK9 inhibitor (Evolocumab, Repatha) with chemotherapy in pancreatic cancer” NCT04862260 ↗ “Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months” NCT05043740 ↗ “Evolocumab (Repatha®) will be administered subcutaneously once monthly in the abdomen, thigh, or upper arm for the duration of the treatment period (one year).” NCT03734211 ↗ “The purpose of this study is to evaluate the effect of evolocumab (Repatha®)-a Food and Drug Administration (FDA)-approved biological drug” NCT04510844 ↗ “Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks.” NCT03944577 ↗ “Subjects will receive evolocumab (Repatha) 140 mg subcutaneously every 2 weeks for 26 weeks.” NCT04710368 ↗ “Evolocumab (trade name: Repatha) which is a PCSK-9 inhibitor developed by Amgen, Inc” NCT04608474 ↗ “Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]” NCT05613426 ↗ “evolocumab (Repatha) 420mg injection once monthly” NCT03193047 ↗ “Drug: Evolocumab 140 MG/ML [Repatha]” NCT04338165 ↗ |
| Known as | Repatha sureclick | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364655 ↗ |
| Known as | Repatha; AMG 145 | “Repatha; AMG 145” NCT03433755 ↗ |
| Action | Inhibit | “a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9)” PMID 25773607 ↗ Mar 2015 |
| Modality | Monoclonal antibody | “Monoclonal Antibody Against PCSK9” NCT01375777 ↗ |
| Route | Subcutaneous | “Administered by subcutaneous injection” NCT01133522 ↗ |
| Target | PCSK9 | “Anti-PCSK9 Antibody” NCT01375764 ↗ |