Drugs / Alirocumab
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed homozygous familial hypercholesterolemia 1 milestone | |||||
| Filed | US (FDA) | Praluent | homozygous familial hypercholesterolemia | 2020-08-05 | “Praluent® (alirocumab) The Company submitted a supplemental Biologics License Application (sBLA) for homozygous familial hypercholesterolemia (HoFH) in adults.” regeneron.com ↗ |
| Filed hyperlipidemia 1 milestone | |||||
| Filed | US (FDA) | Praluent | hyperlipidemia | 2018-11-06 | “An sBLA and a Marketing Authorization Application (MAA) for Praluent for cardiovascular risk reduction have been recently submitted.” regeneron.com ↗ “The sBLA for use of Praluent with apheresis was filed with the FDA, with a target action date of August 24, 2018.” regeneron.com ↗ “The FDA also accepted for review an sBLA for Praluent for first-line treatment of hyperlipidemia” regeneron.com ↗ “An sBLA for first-line treatment of hyperlipidemia has also been recently submitted.” regeneron.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (7) | US (FDA) | PRALUENT | — | 2017-04-24 – 2025-10-09 | fda.gov ↗ |
| Filed | US (FDA) | Praluent | major adverse cardiovascular events | 2018-09-12 | “An sBLA for Praluent as a potential treatment to reduce major adverse cardiovascular events was accepted for review by the FDA” regeneron.com ↗ “FDA has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection” regeneron.com ↗ |
| Approved | EU (EMA) | Praluent | — | 2015-09-23 | europa.eu ↗ |
| Approved | US (FDA) | PRALUENT | — | 2015-07-24 | fda.gov ↗ |
| Filed | EU (EMA) | Praluent | cardiovascular risk reduction | — | “An sBLA and a Marketing Authorization Application (MAA) for Praluent for cardiovascular risk reduction have been recently submitted.” regeneron.com ↗ |
Trials 84 · started per year
today
US approved 2015
EU approved 2015
1
2
7
15
6
1
4
8
7
8
5
2
3
2
4
1
2
4
2
20102011201220132014201520162017201820192020202120222023202420252026202720282029
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT05469347 | Jan 2023 → Feb 2025 | infectious disease with sepsis | Jonathan Sevransky | Completed | No outcome recorded |
| Phase 1 | NCT04781322 | Oct 2021 → Dec 2026 expected | alcohol abuse, alcoholic liver disease | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Recruiting | No outcome recorded |
| Phase 1 | NCT04189484 | Jan 2020 → Apr 2021 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT02979015 | Nov 2016 → Nov 2017 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01959971 | Dec 2013 → May 2015 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01785329 | Feb → Jul 2013 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01723735 | Nov 2012 → Jul 2013 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01670734 | Sep 2012 → May 2013 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01443650 | Jul → Nov 2011 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01448304 | Jun → Sep 2011 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01448317 | May 2011 → Jan 2012 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01448239 | Feb → May 2011 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01161082 | Jun 2010 → May 2011 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01074372 | Mar → Nov 2010 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01026597 | Nov 2009 → Oct 2010 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 213 trials · 6 met primary · 1 missed | ||||||
| Phase 2 | NCT07477704 | Jun → Dec 2026 expected | hyperlipidemia | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06385262 | Mar 2025 → Oct 2028 | non-small cell lung carcinoma | Duke University | Suspended | No outcome recorded |
| Phase 2 | NCT05553834 | May 2023 → Sep 2025 overdue | non-small cell lung carcinoma | Duke University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03537742 | May 2019 → Jul 2025 | vascular disorder | Stanford University | Completed | Missed primary |
| Phase 2 | NCT03718286 | Mar 2019 → Jun 2021 | ST-elevation myocardial infarction, acute coronary syndrome, hyperlipidemia | Population Health Research Institute | Completed | Met primary |
| Phase 2 | NCT03004001 | Jan 2017 → Dec 2019 | nephrotic syndrome | Gloria Vega | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02890992 | Sep 2016 → Sep 2018 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01812707 | Mar 2013 → Jan 2014 | hyperlipoproteinemia | Sanofi | Completed | Met primary |
| Phase 2 | NCT01576484 | Feb 2012 → Dec 2016 | familial hypercholesterolemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01604824 | Feb 2012 → Jun 2014 | familial hypercholesterolemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01266876 | Jan → Nov 2011 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01288469 | Jan → Sep 2011 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 2 | NCT01288443 | Jan → Dec 2011 | hyperlipoproteinemia | Sanofi | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07174375 | Sep 2025 → Dec 2027 expected | ischemic stroke | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 331 trials · 20 met primary · 1 missed | ||||||
| Phase 3 | NCT07586540 | Jul 2027 → Mar 2030 expected | carotid stenosis | Middle East North Africa Stroke and Interventional Neurotherapies Organization | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04968509 | Mar 2024 → Dec 2027 expected | aortic valve stenosis | Beijing Anzhen Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT06080256 | Dec 2023 → Dec 2024 | cerebral artery stenosis, cerebral atherosclerosis | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT03344692 | Feb 2019 → Apr 2022 | type 2 diabetes mellitus | Nantes University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03510715 | Aug 2018 → Feb 2020 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03510884 | May 2018 → Jan 2021 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT03480568 | May 2018 → Aug 2020 overdue | atherosclerosis, hyperlipidemia | Baylor Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT03207945 | Apr 2018 → Aug 2025 | HIV infectious disease, cardiovascular disorder, hyperlipidemia | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT03415178 | Mar → Aug 2018 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03156621 | Oct 2017 → Sep 2019 | homozygous familial hypercholesterolemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03067844 | Apr 2017 → Oct 2021 | coronary atherosclerosis | Insel Gruppe AG, University Hospital Bern | Completed | Met primary |
| Phase 3 | NCT02715726 | Jul 2016 → Aug 2018 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT02584504 | Nov 2015 → Apr 2017 | hyperlipoproteinemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT02585778 | Oct 2015 → Apr 2017 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT02476006 | Jun 2015 → Apr 2019 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02326220 | Mar 2015 → Jan 2016 | familial hypercholesterolemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02107898 | Mar 2014 → Jan 2015 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01954394 | Dec 2013 → Jun 2017 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02023879 | Dec 2013 → Oct 2014 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01926782 | Sep 2013 → Sep 2014 | hyperlipoproteinemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01709500 | Dec 2012 → May 2014 | familial hypercholesterolemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01730053 | Nov 2012 → Apr 2014 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01730040 | Oct 2012 → Apr 2014 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01663402 | Oct 2012 → Jan 2018 | atherosclerotic cardiovascular disease | Sanofi | Completed | Met primary |
| Phase 3 | NCT01709513 | Sep 2012 → May 2014 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01644188 | Aug 2012 → May 2014 | hyperlipoproteinemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01644474 | Jul 2012 → Jul 2013 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01644175 | Jul 2012 → Apr 2014 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01623115 | Jul 2012 → Apr 2014 | familial hypercholesterolemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01617655 | Jun 2012 → May 2014 | familial hypercholesterolemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT01507831 | Jan 2012 → Nov 2014 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 417 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT07819643 | Jan 2027 → Jan 2029 expected | carotid stenosis, cerebral atherosclerosis | Keqiang Zhao | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07581808 | May 2026 → May 2027 expected | atherosclerotic cardiovascular disease, hyperlipidemia | University Medical Centre Ljubljana | Recruiting | No outcome recorded |
| Phase 4 | NCT06083961 | Oct 2023 → Oct 2026 expected | ischemic stroke | Sun U. Kwon | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05292404 | Oct 2022 → Jun 2026 overdue | acute myocardial infarction | Shanghai Tong Ren Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04731155 | Apr 2021 → Oct 2025 overdue | — | Shanghai Tong Ren Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04193306 | Nov 2019 → May 2025 | — | Institute for Clinical and Experimental Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT04851769 | Mar 2019 → Jan 2021 | — | Beijing Anzhen Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03694197 | Sep 2018 → Apr 2020 | familial hypercholesterolemia | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT05465278 | May 2018 → Mar 2022 | familial hypercholesterolemia | Fundación Hipercolesterolemia Familiar | Completed | No outcome recorded |
| Phase 4 | NCT03529253 | Apr 2018 → Sep 2020 | coronary artery disorder | Kobe University | Unknown | No outcome recorded |
| Phase 4 | NCT03552432 | Aug 2017 → Sep 2020 | coronary artery disorder | Kobe University | Unknown | No outcome recorded |
| Phase 4 | NCT02959047 | Jul 2017 → May 2023 | peripheral arterial disease | University of Virginia | Completed | Missed primary |
| Phase 4 | NCT02984982 | Nov 2016 → Jul 2018 | acute coronary syndrome, hyperlipidemia | Sanofi | Completed | Missed primary |
| Phase 4 | NCT02957682 | Nov 2016 → Mar 2020 | hyperlipoproteinemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02992301 | Nov 2016 → Nov 2019 | atherosclerosis, hyperlipidemia | Westside Medical Associates of Los Angeles | Unknown | No outcome recorded |
| Phase 4 | NCT02941016 | Oct 2016 → Oct 2020 | combined low LDL and fibrinogen | Rigshospitalet, Denmark | Withdrawn | No outcome recorded |
| Phase 4 | NCT02642159 | Mar 2016 → Mar 2017 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase not applicable7 trials | ||||||
| — | NCT07704918 | Dec 2026 → Dec 2027 expected | melanoma | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| — | NCT06791031 | Jan 2026 → Dec 2027 expected | coronary atherosclerosis | West China Hospital | Not yet recruiting | 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 |
| — | NCT04613167 | Nov 2020 → Jun 2021 | acute coronary syndrome, coronary artery disorder, hyperlipoproteinemia | University Medical Centre Ljubljana | Unknown | No outcome recorded |
| — | NCT03355027 | Nov 2017 → Sep 2019 | atherosclerosis | Cambridge University Hospitals NHS Foundation Trust | Unknown | No outcome recorded |
| — | NCT03273972 | Sep 2017 → Oct 2018 | atherosclerosis | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 0 | NCT03507374 Comparator | Oct 2018 → Apr 2020 | hemorrhage, intracerebral, susceptibility to, intracranial arteriosclerosis, ischemic stroke | University of Utah | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03014830 Comparator | Jun 2017 → Jun 2018 | atherosclerosis, coronary artery disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT05001984 Comparator | Aug 2021 → Apr 2025 overdue | intracranial arteriosclerosis, ischemic stroke | Chang Gung Memorial Hospital | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03634293 Comparator | Jan 2019 → Jan 2021 | infectious disease with sepsis | Wolfson Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT04790513 Comparator | Apr 2021 → Sep 2022 | cardiovascular disorder, hyperlipidemia | LIB Therapeutics LLC | Completed | No outcome recorded |
| Phase 3 | NCT02289963 Comparator | Jan 2015 → Apr 2016 | hyperlipidemia | Sanofi | 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 | 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 | NCT03750760 Comparator | Jan → Dec 2020 | hyperlipidemia, myocardial infarction | Imperial College London | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03542110 Comparator | Aug 2018 → Jun 2020 | atherosclerosis | Minneapolis Heart Institute Foundation | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02938949 Comparator | Jan 2017 → Aug 2018 | hyperlipoproteinemia, myocardial infarction | Virginia Commonwealth University | Completed | No outcome recorded |
| — | 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 |
| — | NCT05457582 Comparator | Mar 2023 → Sep 2026 overdue | acute coronary syndrome, hyperlipidemia | Nanjing First Hospital, Nanjing Medical University | 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 · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-03-11 | Regeneron Pharmaceuticals | Regulatory Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol regeneron.com ↗ |
| 2020-03-30 | Regeneron Pharmaceuticals | Results Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol regeneron.com ↗
Results from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented; |
| 2019-04-26 | Regeneron Pharmaceuticals | Regulatory FDA Approves Praluent® (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Praluent® (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. |
| 2019-03-15 | Regeneron Pharmaceuticals | Regulatory Praluent® (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease regeneron.com ↗ |
| 2019-03-13 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi to Present New Praluent® (alirocumab) Data at ACC.19 regeneron.com ↗
An oral presentation that shows Praluent treatment was associated with larger reductions in the risk of major adverse CV events (MACE) and death in patients with polyvascular disease, compared to those without. |
| 2019-02-04 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends Approval of Praluent® (alirocumab) Injection to Reduce Cardiovascular Risk in People with Established Atherosclerotic Cardiovascular Disease regeneron.com ↗ |
| 2018-11-11 | Regeneron Pharmaceuticals | Results ODYSSEY OUTCOMES Investigators Highlight at AHA that Praluent® (alirocumab) Injection Was Associated with Fewer Deaths from Any Cause regeneron.com ↗
Praluent® (alirocumab) Injection was associated with fewer deaths from any cause among patients who had previously experienced a heart attack or unstable angina (known as acute coronary syndrome, or ACS), and this was enhanced in patients who were followed for at least 3 years and those who had an LDL-C (low-density lipoprotein cholesterol) of 100 mg/dL or higher at baseline. |
| 2018-11-07 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Positive Detailed Results From Praluent® (alirocumab) Injection Cardiovascular Outcomes Trial regeneron.com ↗
The trial met its primary endpoint, showing that Praluent® (alirocumab) Injection significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered an acute coronary syndrome (ACS), which included a heart attack or unstable angina. |
| 2018-09-12 | Regeneron Pharmaceuticals | Regulatory FDA to Review Supplemental Biologics License Application for Praluent® (alirocumab) Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. |
| 2018-03-10 | Regeneron Pharmaceuticals | Results Praluent® (alirocumab) Injection Significantly Reduced Risk of Cardiovascular Events in High-Risk Patients, and was Associated with Lower Death Rate regeneron.com ↗
On the primary endpoint, Praluent reduced the overall risk of MACE by 15% (HR=0.85, CI: 0.78-0.93, p=0.0003). |
All press releases naming this drug 21 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 99 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alirocumab | “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 ↗93“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 ↗ “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 ↗ “The addition of alirocumab to statins can not only provide additional LDL cholesterol lowering effects but also have a potential role in promoting a more stable plaque phenotype.” PMID 34511134 ↗ Sep 2021 “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 ↗ “PCSK9 inhibitors (Evolocumab 140 mg or Alirocumab 75 mg or Alirocumab 150 mg) plus Ezetimibe 10 mg plus Bempedoic acid (Treatment A)” NCT06381947 ↗ “monotherapy with a PCSK9 inhibitor (evolocumab 140 mg or alirocumab 150 mg once every 2 weeks subcutaneously)” NCT05537948 ↗ “Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.” NCT05457582 ↗ “Alirocumab Description: 75 mg subcutaneous injection every 2 weeks.” NCT07819643 ↗ |
| Known as | Praluent | “Evolocumab (Repatha®) 140 mg or Alirocumab(Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months” NCT05043740 ↗7“effect 18 months after initiation of alirocumab (Praluent®) on the volume, architecture, and composition of the coronary atheroma plaque” NCT05465278 ↗ “prefilled pen containing 75 mg of Praluent (Alirocumab) in 1 ml of solution” NCT03344692 ↗ “Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily” NCT03529253 ↗ “Alirocumab 150 MG/ML [Praluent]” NCT03480568 ↗ “Praluent, Study Drug” NCT03542110 ↗ |
| Known as | REGN727 | “Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).” NCT01812707 ↗13“alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)” NCT01670734 ↗ “We report three phase 1 studies of a monoclonal antibody to PCSK9 designated as REGN727/SAR236553 (REGN727).” PMID 22435370 ↗ Mar 2012 “Drug: alirocumab SAR236553 (REGN727)” NCT02890992 ↗ “Drug: Alirocumab SAR236553 (REGN727)” NCT03510884 ↗ “alirocumab SAR236553 (REGN727)” NCT01448239 ↗ “ALIROCUMAB SAR236553 (REGN727)” NCT02476006 ↗ “Alirocumab SAR236553 (REGN727)” NCT03510715 ↗ “alirocumab SAR236553 (REGN727)” NCT01448304 ↗ “alirocumab SAR236553 (REGN727)” NCT01443650 ↗ “alirocumab SAR236553 (REGN727)” NCT02979015 ↗ |
| Known as | REGN727/SAR236553 | “We report three phase 1 studies of a monoclonal antibody to PCSK9 designated as REGN727/SAR236553 (REGN727).” PMID 22435370 ↗ Mar 2012 |
| Known as | SAR236553 | “alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)” NCT01670734 ↗13“We report three phase 1 studies of a monoclonal antibody to PCSK9 designated as REGN727/SAR236553 (REGN727).” PMID 22435370 ↗ Mar 2012 “Drug: Alirocumab SAR236553 (REGN727)” NCT03510884 ↗ “Drug: alirocumab SAR236553 (REGN727)” NCT02890992 ↗ “Alirocumab SAR236553 (REGN727)” NCT03510715 ↗ “alirocumab SAR236553 (REGN727)” NCT01448239 ↗ “alirocumab SAR236553 (REGN727)” NCT01448304 ↗ “ALIROCUMAB SAR236553 (REGN727)” NCT02476006 ↗ “alirocumab SAR236553 (REGN727)” NCT02979015 ↗ “alirocumab SAR236553 (REGN727)” NCT01443650 ↗ “alirocumab SAR236553 (REGN727)” NCT01785329 ↗ |
| Known as | Sar236553/REG 727 | “Alirocumab (Sar236553/REG 727) is a fully humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation...” NCT03207945 ↗ |
| Action | Inhibit | “CONCLUSIONS: In three phase 1 trials, a monoclonal antibody to PCSK9 significantly reduced LDL cholesterol levels in healthy volunteers and in subjects with familial or...” PMID 22435370 ↗ Mar 2012 |
| Modality | Monoclonal antibody | “We report three phase 1 studies of a monoclonal antibody to PCSK9 designated as REGN727/SAR236553 (REGN727).” PMID 22435370 ↗ Mar 2012 |
| Route | Intravenous | “The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit.” NCT01026597 ↗ |
| Target | PCSK9 | “a monoclonal antibody to PCSK9 designated as REGN727/SAR236553 (REGN727)” PMID 22435370 ↗ Mar 2012 |