Drugs / Alirocumab
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | PRALUENT | — | 2017-04-24 – 2025-10-09 | fda.gov ↗ |
| Approved | EU (EMA) | Praluent | — | 2015-09-23 | europa.eu ↗ |
| Approved | US (FDA) | PRALUENT | — | 2015-07-24 | fda.gov ↗ |
Trials 83 · started per year
today
US approved 2015
EU approved 2015
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| 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT03718286 | Mar 2019 → Jun 2021 | ST-elevation myocardial infarction, acute coronary syndrome, hyperlipidemia | Population Health Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT03004001 | Jan 2017 → Dec 2019 | nephrotic syndrome | Gloria Vega | Terminated | No outcome recorded |
| Phase 2 | NCT02890992 | Sep 2016 → Sep 2018 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01812707 | Mar 2013 → Jan 2014 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01288443 | Jan → Dec 2011 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01266876 | Jan → Nov 2011 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01288469 | Jan → Sep 2011 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT03067844 | Apr 2017 → Oct 2021 | coronary atherosclerosis | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 3 | NCT02715726 | Jul 2016 → Aug 2018 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02584504 | Nov 2015 → Apr 2017 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02585778 | Oct 2015 → Apr 2017 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02107898 | Mar 2014 → Jan 2015 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01954394 | Dec 2013 → Jun 2017 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02023879 | Dec 2013 → Oct 2014 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01926782 | Sep 2013 → Sep 2014 | hyperlipoproteinemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01709500 | Dec 2012 → May 2014 | familial hypercholesterolemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01730053 | Nov 2012 → Apr 2014 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01663402 | Oct 2012 → Jan 2018 | atherosclerotic cardiovascular disease | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01730040 | Oct 2012 → Apr 2014 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01709513 | Sep 2012 → May 2014 | hyperlipidemia | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01644188 | Aug 2012 → May 2014 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01644474 | Jul 2012 → Jul 2013 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01623115 | Jul 2012 → Apr 2014 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01644175 | Jul 2012 → Apr 2014 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01617655 | Jun 2012 → May 2014 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01507831 | Jan 2012 → Nov 2014 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| 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 | No outcome recorded |
| Phase 4 | NCT02984982 | Nov 2016 → Jul 2018 | acute coronary syndrome, hyperlipidemia | Sanofi | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 14 trials
Press releases naming this drug 20 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-03-11 | Regeneron Pharmaceuticals | Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol regeneron.com ↗ |
| 2021-02-11 | Regeneron Pharmaceuticals | U.S. Federal Circuit Court of Appeals Rules in Favor of Regeneron and Sanofi in Praluent® (alirocumab) Patent Litigation regeneron.com ↗ |
| 2020-10-29 | Sanofi | European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent® (alirocumab) sanofi.com ↗ |
| 2020-04-06 | Sanofi | Sanofi finalizes Praluent® (alirocumab) restructuring with Regeneron sanofi.com ↗ |
| 2020-04-06 | Regeneron Pharmaceuticals | Regeneron Finalizes Praluent® (alirocumab) Restructuring and Updates Accounting Presentation regeneron.com ↗ |
| 2019-12-10 | Regeneron Pharmaceuticals | Regeneron and Sanofi Announce Intent to Restructure Antibody Collaboration for Kevzara® (sarilumab) and Praluent® (alirocumab) regeneron.com ↗ |
| 2019-04-26 | Regeneron Pharmaceuticals | FDA Approves Praluent® (alirocumab) to Prevent Heart Attack, Stroke and Unstable Angina Requiring Hospitalization regeneron.com ↗ |
| 2019-03-15 | Regeneron Pharmaceuticals | 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 | Regeneron and Sanofi to Present New Praluent® (alirocumab) Data at ACC.19 regeneron.com ↗ |
| 2019-02-11 | Regeneron Pharmaceuticals | Regeneron and Sanofi Offer Praluent® (alirocumab) at a New Reduced U.S. List Price regeneron.com ↗ |
| 2019-02-04 | Regeneron Pharmaceuticals | 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 | ODYSSEY OUTCOMES Investigators Highlight at AHA that Praluent® (alirocumab) Injection Was Associated with Fewer Deaths from Any Cause regeneron.com ↗ |
| 2018-11-07 | Regeneron Pharmaceuticals | New England Journal of Medicine Publishes Positive Detailed Results From Praluent® (alirocumab) Injection Cardiovascular Outcomes Trial regeneron.com ↗ |
| 2018-09-12 | Regeneron Pharmaceuticals | FDA to Review Supplemental Biologics License Application for Praluent® (alirocumab) Injection as Potential Treatment to Reduce Major Adverse Cardiovascular Events regeneron.com ↗ |
| 2018-05-01 | Regeneron Pharmaceuticals | Regeneron and Sanofi to Lower Net Price of Praluent® (alirocumab) Injection in Exchange for Straightforward, More Affordable Patient Access for Express Scripts Patients regeneron.com ↗ |
| 2018-03-10 | Regeneron Pharmaceuticals | Regeneron and Sanofi Announce Plans to Make Praluent® (alirocumab) More Accessible and Affordable for Patients with the Greatest Health Risk and Unmet Need regeneron.com ↗ |
| 2018-03-10 | Regeneron Pharmaceuticals | Praluent® (alirocumab) Injection Significantly Reduced Risk of Cardiovascular Events in High-Risk Patients, and was Associated with Lower Death Rate regeneron.com ↗ |
| 2017-11-07 | Regeneron Pharmaceuticals | Regeneron and Sanofi to Present New Analyses from the Praluent® (alirocumab) Injection ODYSSEY Clinical Trial Program at the AHA Scientific Sessions 2017 regeneron.com ↗ |
| 2017-10-05 | Regeneron Pharmaceuticals | Appellate Court Orders a New Trial and Vacates Permanent Injunction in Ongoing Patent Case Regarding Praluent® (alirocumab) regeneron.com ↗ |
| 2017-08-25 | Regeneron Pharmaceuticals | Regeneron and Sanofi to Present New Analyses from Praluent® (alirocumab) Injection Trials at the ESC Congress 2017 regeneron.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 98 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 ↗92“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 arm (which is a therapy designed to lower cholesterol)” NCT03273972 ↗ “Praluent (Alirocumab)” NCT02957682 ↗ |
| 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)” NCT03510884 ↗ “Drug: alirocumab SAR236553 (REGN727)” NCT02890992 ↗ “alirocumab SAR236553 (REGN727)” NCT02979015 ↗ “alirocumab SAR236553 (REGN727)” NCT01785329 ↗ “Alirocumab SAR236553 (REGN727)” NCT03510715 ↗ “ALIROCUMAB SAR236553 (REGN727)” NCT02476006 ↗ “alirocumab SAR236553 (REGN727)” NCT01448239 ↗ “alirocumab SAR236553 (REGN727)” NCT01443650 ↗ “alirocumab SAR236553 (REGN727)” NCT01448304 ↗ |
| 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)” NCT01448239 ↗ “alirocumab SAR236553 (REGN727)” NCT02979015 ↗ “alirocumab SAR236553 (REGN727)” NCT01448304 ↗ “alirocumab SAR236553 (REGN727)” NCT01785329 ↗ “alirocumab SAR236553 (REGN727)” NCT01443650 ↗ “Alirocumab SAR236553 (REGN727)” NCT03510715 ↗ “ALIROCUMAB SAR236553 (REGN727)” NCT02476006 ↗ “Drug: Alirocumab SAR236553” NCT03415178 ↗ “Alirocumab SAR236553” NCT02984982 ↗ “SAR236553” NCT01812707 ↗ |
| 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 |