Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic kidney disease 1 milestone | |||||
| Filed | US (FDA) | ZETIA | chronic kidney disease | 2011-07-29 | “Supplemental New Drug Applications (sNDAs) for the cholesterol-lowering medicines VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) have been accepted for standard review...” merck.com ↗ |
| Filed hyperlipidemia 2 milestones | |||||
| Filed | US (FDA) | — | hyperlipidemia | 2013-01-02 | “The NDA resubmissions for sugammadex, a neuromuscular blockade reversal agent, and ezetimibe/atorvastatin tablets, an investigational combination medicine for hyperlipidemia,...” merck.com ↗ “acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine.” merck.com ↗ |
| Rejected (CRL) | US (FDA) | — | hyperlipidemia | 2012-03-05 | “has issued a Complete Response Letter regarding Merck’s new drug application for ezetimibe and atorvastatin tablets” merck.com ↗ |
| Filed hyperlipidemia, familial combined, LPL related 1 milestone | |||||
| Filed | EU (EMA) | — | hyperlipidemia, familial combined, LPL related | 2025-09-02 | “Menarini submitted two Marketing Authorization Applications to EMA, obicetrapib and obicetrapib/ezetimide.” menarini.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Nustendi | — | 2020-03-27 | europa.eu ↗ |
| Label expansions (5) | US (FDA) | ZETIA | — | 2006-03-16 – 2012-01-24 | fda.gov ↗ |
| Approved | US (FDA) | ZETIA | — | 2002-10-25 | fda.gov ↗ |
Trials 263 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials · 1 met primary | ||||||
| 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 0 | NCT02534376 | Sep 2015 → Feb 2019 | prostate cancer | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT02548936 | Apr 2015 → Oct 2016 | atherosclerosis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT00863265 | Jun → Oct 2009 | coronary artery disorder, hyperlipoproteinemia | Washington University School of Medicine | Completed | Met primary |
| Phase 124 trials · 1 met primary | ||||||
| Phase 1 | NCT07622433 | Jun → Sep 2026 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06578676 | Jun → Sep 2024 overdue | hyperlipidemia, type 2 diabetes mellitus | Hyundai Pharm | Recruiting | No outcome recorded |
| Phase 1 | NCT06050291 | Jan → Apr 2024 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 1 | NCT05372380 | May → Jun 2022 | hyperlipoproteinemia, hypertensive disorder | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05202405 | Jan → Mar 2022 | hyperlipidemia | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06225635 | Jan → Mar 2022 | hyperlipidemia | Shin Poong Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04185090 | Feb → Apr 2020 | hyperlipidemia, hypertensive disorder | IlDong Pharmaceutical Co Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03802526 | Apr → Jul 2019 | — | NVP Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04322266 | Dec 2018 → Feb 2019 | — | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 1 | NCT03586037 | Jun → Aug 2018 | hyperlipidemia, hypertensive disorder | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04081844 | May → Jun 2018 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT02547402 | Dec 2015 → Jan 2016 | acute kidney injury | Complexa, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02501200 | Aug → Dec 2015 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02461004 | Jul → Oct 2015 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02730689 | Dec 2014 → Jan 2015 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 1 | NCT02288338 | Nov 2014 → Feb 2015 | — | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02127320 | Jun → Sep 2014 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT02126137 | Oct 2013 → Jan 2016 | chronic hepatitis C virus infection | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| Phase 1 | NCT01723735 | Nov 2012 → Jul 2013 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01597700 | Jan 2012 | hyperlipidemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01520077 | Jul 2011 → Jan 2015 | alopecia areata | University of Miami | Completed | No outcome recorded |
| Phase 1 | NCT00810303 | Mar → Jul 2009 | — | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 1 | NCT00681525 | Apr → Jun 2008 | — | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT00652431 | May → Jul 2007 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 218 trials · 6 met primary | ||||||
| Phase 2 | NCT07307989 | Aug 2025 → Jul 2029 expected | hyperlipidemia, ischemic stroke | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06437574 | Jul 2024 → Feb 2028 expected | prostate cancer | Cedars-Sinai Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05266586 | Mar → Aug 2022 | hyperlipidemia | NewAmsterdam Pharma | Completed | Met primary |
| Phase 2 | NCT04770389 | Feb → May 2021 | hyperlipidemia, hyperlipoproteinemia | NewAmsterdam Pharma | Completed | Met primary |
| Phase 2 | NCT02971033 | Apr 2018 → Mar 2021 | chronic hepatitis C virus infection | VA Office of Research and Development | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03051100 | Jan → Jun 2017 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT03099278 | Jan → Jun 2017 | hepatitis D virus infection | Ziauddin Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03105310 | Jan → Dec 2016 | hepatitis D virus infection | Aga Khan University | Unknown | No outcome recorded |
| Phase 2 | NCT02244944 | Sep 2014 → Sep 2015 | NAFLD1 | Gregory Graf, PhD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02055976 | Mar 2014 → Jan 2015 | hyperlipidemia | Pfizer | Completed | Met primary |
| Phase 2 | NCT01941836 | Sep 2013 → Oct 2014 | hyperlipoproteinemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01766713 | Jan 2013 → Aug 2014 | metabolic dysfunction-associated steatohepatitis | University of California, San Diego | Completed | No outcome recorded |
| Phase 2 | NCT01375764 | Jul 2011 → May 2012 | hyperlipidemia | Amgen | Completed | Met primary |
| Phase 2 | NCT01218204 | Sep 2010 → Jun 2011 | hyperlipidemia | GlaxoSmithKline | Completed | Mixed |
| Phase 2 | NCT00405067 | May 2006 → Jan 2007 | hyperlipidemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00359281 | Mar 2006 → Nov 2007 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00157482 | Jan 2005 → Dec 2006 | type 2 diabetes mellitus | Mario Negri Institute for Pharmacological Research | Completed | Met primary |
| Phase 2 | NCT00045812 | Mar 2001 → Apr 2004 | — | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT07313124 | Dec 2024 → Nov 2025 | cardiovascular disorder | Beni-Suef University | Completed | No outcome recorded |
| Phase 2/3 | NCT02089867 | Oct 2006 → Aug 2007 | coronary artery disorder | Jose Rocha Faria Neto | Completed | No outcome recorded |
| Phase 2/3 | NCT00566267 | Apr 2006 → Nov 2007 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3103 trials · 27 met primary · 3 missed | ||||||
| Phase 3 | NCT07474649 | Sep 2026 → Jun 2028 expected | coronary atherosclerosis, hyperlipidemia, combined, 2 | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07440381 | Sep 2026 → Aug 2027 expected | acute coronary syndrome | Heart Care Foundation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07219602 | Dec 2025 → Mar 2028 expected | hyperlipidemia, metabolic syndrome X, type 2 diabetes mellitus | NewAmsterdam Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06646354 | Apr → May 2025 overdue | essential hypertension, hyperlipoproteinemia | Hyundai Pharm | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06305559 | May 2024 → Nov 2027 expected | atherosclerosis, coronary artery disorder, hyperlipidemia | NewAmsterdam Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05930028 | Jul 2023 → Sep 2024 | essential hypertension, hyperlipoproteinemia | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT05657574 | Nov 2022 → Jun 2023 | hyperlipoproteinemia | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 3 | NCT05970679 | Aug 2022 → Apr 2023 | hyperlipoproteinemia | Daewon Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT07564726 | Aug 2022 → Feb 2024 | essential hypertension, hyperlipoproteinemia | Celltrion Pharm, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04669041 | Dec 2020 → Jun 2022 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT04659070 | Jul 2020 → May 2022 | essential hypertension, hyperlipoproteinemia | Hanlim Pharm. Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04289649 | Apr → Nov 2020 | hyperlipidemia | Kowa Company, Ltd. | Completed | Met primary |
| Phase 3 | NCT04289662 | Mar 2020 → Aug 2021 | hyperlipidemia | Kowa Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04161001 | Nov 2019 → Nov 2021 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 3 | NCT04584736 | Jun 2019 → Jul 2020 | hyperlipoproteinemia | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT03768427 | May 2019 → Mar 2021 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT03872232 | Feb 2019 → Aug 2020 | essential hypertension, hyperlipoproteinemia | Addpharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04017338 | Aug 2018 → Dec 2020 | disease related to solid organ transplantation, hepatitis C virus infection | Jordan Feld | Unknown | Met primary |
| Phase 3 | NCT02715726 | Jul 2016 → Aug 2018 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT02741245 | Jun 2016 → Jan 2017 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT02748057 | May 2016 → Dec 2017 | familial hypercholesterolemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT02749994 | Apr 2016 → Feb 2017 | hyperlipidemia | IlDong Pharmaceutical Co Ltd | Completed | Met primary |
| Phase 3 | NCT02550288 | Sep 2015 → May 2016 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT02460159 | Jun 2015 → Dec 2016 | familial hypercholesterolemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT02451098 | Mar → Oct 2015 | hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT03288038 | Oct 2014 → Nov 2015 | hyperlipidemia | Shin Poong Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03571087 | Sep 2014 → Aug 2015 | hyperlipoproteinemia | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02445352 | Jul 2014 → Jan 2015 | hyperlipoproteinemia | Alvogen Korea | Completed | No outcome recorded |
| Phase 3 | NCT02251847 | Jul 2014 → Jul 2015 | hyperlipidemia | IlDong Pharmaceutical Co Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT02205606 | Jun 2014 → Feb 2015 | hyperlipidemia | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 3 | NCT01849068 | Jun 2013 → Jun 2015 | metabolic syndrome X | Laval University | Completed | No outcome recorded |
| Phase 3 | NCT01154036 | Jul 2010 → Sep 2012 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT02205775 | May 2010 → Mar 2012 | coronary artery disorder | G. d'Annunzio University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00965055 | Sep 2009 → Sep 2011 | coronary artery disorder, low density lipoprotein cholesterol, mild elevation of | University of California, San Diego | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00867165 | May 2009 → Apr 2012 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00862251 | Apr 2009 → Mar 2011 | cardiovascular disorder, diabetes mellitus | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00782184 | Nov 2008 → Sep 2010 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00783263 | Nov 2008 → May 2010 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00738972 | Jan 2008 → Aug 2010 | hypertensive disorder | Fundación Lindavista del Corazón AC | Terminated | No outcome recorded |
| Phase 3 | NCT00654095 | Dec 2007 → Jun 2009 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00653523 | Dec 2007 → Jun 2009 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00535405 | Nov 2007 → Mar 2009 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00664469 | Aug 2007 → Mar 2010 | hyperlipidemia | Sunnybrook Health Sciences Centre | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00525824 | Aug 2007 → Sep 2008 | atherosclerosis, coronary artery disorder, hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00496730 | Jul 2007 → Aug 2008 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00462748 | Mar 2007 → Jun 2008 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00479713 | Feb 2007 → Mar 2008 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00409773 | Jan 2007 → Jul 2008 | hyperlipidemia, metabolic syndrome X | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00395603 | Sep 2006 → Jun 2007 | cardiovascular disorder, diabetes mellitus | Organon and Co | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00413972 | Apr → Nov 2006 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00276458 | Feb 2006 → Jan 2008 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00276484 | Feb 2006 → Feb 2008 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00267267 | Jan 2006 → Jan 2007 | hyperlipidemia | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00101439 | Nov 2005 → Oct 2006 | hyperlipidemia | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00651560 | Nov → Dec 2005 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00129402 | Aug 2005 → Jun 2007 | familial hypercholesterolemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00423488 | Jul 2005 → Feb 2007 | coronary artery disorder, hyperlipidemia, type 2 diabetes mellitus | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00110435 | May → Dec 2005 | familial hypercholesterolemia, type 2 diabetes mellitus | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00457275 | Apr → Nov 2005 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00395473 | Mar → Nov 2005 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00541697 | Jan → Sep 2005 | type 2 diabetes mellitus | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00132717 | Jan 2005 → Jun 2007 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00349284 | Jan 2005 → ? | hyperlipidemia, combined, 2 | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00099996 | Dec 2004 → Dec 2005 | heart disorder, sterol metabolism disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00093899 | Nov 2004 → Sep 2005 | hyperlipidemia, hyperlipoproteinemia, hypertriglyceridemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092898 | Oct 2004 → Sep 2005 | heart disorder, inherited lipid metabolism disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00195793 | Aug 2004 → ? | hyperlipidemia | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00650819 | Jun 2004 → Feb 2005 | hyperlipoproteinemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00328523 | Jun 2004 → Jan 2006 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00653445 | Jun 2004 → Jun 2005 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00090298 | Apr → Dec 2004 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00090168 | Jan → Oct 2004 | atherosclerosis, coronary artery disorder, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00651404 | Jan → Dec 2004 | atherosclerosis, hyperlipoproteinemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00651391 | Oct 2003 → Sep 2004 | atherosclerosis, hyperlipidemia | Organon and Co | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00171288 | Aug 2003 → Aug 2005 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00652301 | Jul 2003 → Apr 2004 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092690 | Jun 2003 → Mar 2004 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092612 | May 2003 → Jun 2004 | coronary artery disorder, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00650689 | May 2003 → Dec 2004 | atherosclerosis, coronary artery disorder, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092638 | May 2003 → Jul 2004 | coronary artery disorder, hyperlipoproteinemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092573 | Apr 2003 → Nov 2004 | hyperlipidemia, hypertriglyceridemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092625 | Mar 2003 → Jul 2004 | coronary artery disorder, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092599 | Feb 2003 → Jun 2004 | coronary artery disorder, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092664 | Jan → Sep 2003 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092560 | Dec 2002 → Dec 2003 | hyperlipidemia, hypertriglyceridemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00157911 | Dec 2002 → Oct 2003 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092651 | Sep 2002 → Jun 2003 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092586 | Sep 2002 → Oct 2003 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092833 | Jul 2002 → May 2005 | familial hypercholesterolemia | Organon and Co | Terminated | No outcome recorded |
| Phase 3 | NCT00552097 | Jun 2002 → Apr 2006 | atherosclerosis, familial hypercholesterolemia | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00092716 | May 2002 → Apr 2003 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00551447 | Jan 2002 → Mar 2003 | coronary artery disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00551876 | Dec 2001 → Jan 2003 | type 2 diabetes mellitus | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092820 | Feb → Sep 2001 | heart disorder, inherited lipid metabolism disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092807 | Feb → Sep 2001 | heart disorder, inherited lipid metabolism disorder | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT03882892 | Feb 2001 → Aug 2002 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT03882905 | Jan → Jul 2001 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00092677 | Jan 2001 → Apr 2008 | aortic valve stenosis | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT03885921 | Oct 2000 → Jul 2003 | homozygous familial hypercholesterolemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT03882996 | Oct 2000 → Feb 2003 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT03884452 | May 2000 → May 2001 | familial hypercholesterolemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT03867318 | Apr 2000 → Nov 2001 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 3 | NCT03867110 | Mar 2000 → Jul 2001 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 482 trials · 18 met primary · 5 missed | ||||||
| Phase 4 | NCT07799779 | Sep 2026 → Sep 2029 expected | acute coronary syndrome | Seoul National University Bundang Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07508254 | May → Oct 2026 expected | acute coronary syndrome, hyperlipidemia | Punjab Institute of Cardology | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06722521 | Jul 2025 → Jun 2032 expected | calcinosis | Asan Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT07839741 | Jun 2025 → Jan 2027 expected | atherosclerotic cardiovascular disease, low density lipoprotein cholesterol, mild elevation of | University of Porto | Recruiting | No outcome recorded |
| Phase 4 | NCT06767345 | May 2025 → Nov 2027 expected | coronary atherosclerosis | Korea University Anam Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06767774 | Apr 2025 → Aug 2029 expected | atherosclerotic cardiovascular disease, diabetes mellitus | Korea University Anam Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06789432 | Feb → Oct 2025 | hyperlipidemia | Dr. Md. Alimur Reza | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06784557 | Feb 2024 → Jul 2025 overdue | atherosclerotic cardiovascular disease | Yonsei University | Recruiting | No outcome recorded |
| Phase 4 | NCT06186037 | Feb 2024 → Feb 2029 expected | coronary artery disorder, hyperlipidemia | Saint Vincent's Hospital, Korea | Recruiting | No outcome recorded |
| Phase 4 | NCT07442630 | Aug 2023 → Jan 2026 overdue | hyperlipidemia | JW Pharmaceutical | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06021951 | Aug 2023 → Feb 2024 | — | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT05761444 | Jul 2023 → Sep 2024 | atherosclerotic cardiovascular disease | Organon and Co | Completed | Met primary |
| Phase 4 | NCT05845424 | Jul 2023 → Jun 2029 expected | coronary artery disorder, hyperlipidemia, metabolic syndrome X | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05641753 | Dec 2022 → Jul 2027 expected | type 1 diabetes mellitus | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 4 | NCT05884502 | Sep 2022 → Dec 2023 | hyperlipidemia, ischemic stroke | Korea University Anam Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05361421 | Jul 2022 → Oct 2027 expected | cardiovascular disorder | Yonsei University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04433533 | Jan 2021 → Jun 2023 | heart disorder, hyperlipidemia | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT04499859 | Oct 2020 → Aug 2026 overdue | myocardial infarction, statin toxicity | Kiyuk Chang, MD,PhD | Recruiting | No outcome recorded |
| Phase 4 | NCT04508907 | Sep 2020 → Nov 2025 overdue | disease related to solid organ transplantation, hepatitis C virus infection | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04369664 | Aug 2020 → Sep 2023 | type 2 diabetes mellitus | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT04347434 | Feb 2020 → Nov 2027 expected | acute myocardial infarction, arteriosclerosis disorder | Penza State University | Recruiting | No outcome recorded |
| Phase 4 | NCT04700436 | Jan 2020 → May 2021 | hyperlipidemia, type 2 diabetes mellitus | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03993236 | Sep 2019 → Sep 2021 | ischemic stroke | Keun-Sik Hong | Completed | Met primary |
| Phase 4 | NCT03597412 | Oct 2018 → Aug 2020 | atherosclerotic cardiovascular disease, type 2 diabetes mellitus | Yuhan Corporation | Completed | No outcome recorded |
| Phase 4 | NCT03847506 | Jul 2018 → Dec 2020 | hyperlipidemia | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 4 | NCT03434613 | May 2018 → Sep 2019 | NAFLD1, hyperlipidemia | Yonsei University | Completed | Met primary |
| Phase 4 | NCT03403556 | Mar 2018 → Oct 2021 | atherosclerotic cardiovascular disease, type 2 diabetes mellitus | Yuhan Corporation | Unknown | No outcome recorded |
| Phase 4 | NCT03494270 | Mar 2018 → Sep 2019 | atherosclerotic cardiovascular disease | Yuhan Corporation | Completed | Met primary |
| Phase 4 | NCT04080310 | Mar 2018 → Jun 2019 | cardiovascular disorder | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03446261 | Feb 2018 → Mar 2019 | hyperlipidemia, type 2 diabetes mellitus | Yuhan Corporation | Completed | Met primary |
| Phase 4 | NCT03217409 | Aug 2017 → Apr 2019 | diabetes mellitus | Yuhan Corporation | Completed | No outcome recorded |
| Phase 4 | NCT04056169 | Jun 2017 → Jul 2019 | acute coronary syndrome, arterial disorder | Yuhan Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02588235 | Oct 2015 → Nov 2017 | coronary artery disorder | Xijing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02378064 | May 2015 → Dec 2017 | atherosclerosis, coronary artery disorder | CHEOL WHAN LEE, M.D., Ph.D | Completed | Missed primary |
| Phase 4 | NCT02103049 | Apr 2014 → Nov 2015 | hyperlipidemia | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT01950884 | Oct 2013 → Oct 2014 | metabolic dysfunction-associated steatohepatitis | University of Palermo | Unknown | Missed primary |
| Phase 4 | NCT02768545 | Jun 2013 → May 2016 | chronic hepatitis C virus infection | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| Phase 4 | NCT01611883 | Jul 2012 → Jan 2014 | — | Organon and Co | Completed | Met primary |
| Phase 4 | NCT01385631 | Jun 2011 → Jun 2014 | ST-elevation myocardial infarction | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01068093 | Oct 2010 → Oct 2015 | coronary artery disorder | Yokohama City University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01185236 | Sep 2010 → Aug 2011 | type 2 diabetes mellitus | Seoul National University Hospital | Unknown | Missed primary |
| Phase 4 | NCT01043380 | Jan 2010 → Mar 2014 | coronary artery disorder, hyperlipidemia | Kumamoto University | Completed | Met primary |
| Phase 4 | NCT01086020 | Jan 2010 → Dec 2011 | coronary atherosclerosis | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01857843 | Nov 2009 → Nov 2013 | acute coronary syndrome | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00905905 | May → Dec 2009 | myocardial infarction | Brasilia Heart Study Group | Completed | No outcome recorded |
| Phase 4 | NCT00817843 | Apr 2009 → Sep 2010 | metabolic syndrome X | dr.Frank L.J. Visseren | Completed | Missed primary |
| Phase 4 | NCT00843661 | Mar 2009 → Dec 2011 | HIV infectious disease, hyperlipidemia | Ospedale di Circolo - Fondazione Macchi | Unknown | No outcome recorded |
| Phase 4 | NCT00871351 | Feb 2009 → May 2010 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT01008345 | Sep 2008 → Jun 2009 | coronary artery disorder, diabetes mellitus | Hotel Dieu de France Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00699023 | Jun 2008 → Oct 2009 | hyperlipidemia, type 2 diabetes mellitus | Federico II University | Completed | No outcome recorded |
| Phase 4 | NCT00701727 | Jun 2008 → Mar 2009 | hyperlipidemia | Radiant Research | Completed | Met primary |
| Phase 4 | NCT00654628 | Aug 2007 → Jul 2009 | hyperlipoproteinemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00481351 | Jun 2007 → Jan 2010 | coronary artery disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT00433823 | Jan 2007 → Jan 2008 | atherosclerosis, coronary artery disorder, diabetes mellitus | Abant Izzet Baysal University | Unknown | No outcome recorded |
| Phase 4 | NCT00442897 | Sep 2006 → Oct 2008 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00376246 | Sep 2006 → Apr 2008 | — | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT00385658 | Aug 2006 → Mar 2007 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00423579 | Jul 2006 → Mar 2008 | coronary artery disorder, hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00794677 | Jun 2006 → Feb 2008 | hyperlipoproteinemia | UCSF Benioff Children's Hospital Oakland | Completed | Met primary |
| Phase 4 | NCT01035320 | Jan 2006 → Jun 2012 | diabetes mellitus, impaired renal function disease | Karolinska Institutet | Completed | No outcome recorded |
| Phase 4 | NCT00652327 | Dec 2005 → Jul 2007 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00166530 | Nov 2005 → Feb 2007 | atherosclerosis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00157924 | Nov 2005 → Sep 2007 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00166504 | Oct 2005 → Oct 2007 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00319449 | Sep 2005 → Oct 2006 | arteriosclerosis disorder, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00652847 | May 2005 → May 2007 | hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00202904 | May 2005 → Oct 2006 | coronary artery disorder, hyperlipoproteinemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00449410 | May 2005 → Oct 2006 | atrial fibrillation | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00738296 | Apr → Dec 2005 | cardiovascular disorder | Hospital Universitario 12 de Octubre | Completed | No outcome recorded |
| Phase 4 | NCT00652717 | Feb 2005 | cardiovascular disorder | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00466401 | Feb 2005 → Aug 2007 | hyperlipidemia | Ziv Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00189085 | Dec 2004 → Jul 2005 | metabolic syndrome X | UMC Utrecht | Completed | No outcome recorded |
| Phase 4 | NCT00651963 | Sep 2004 → Mar 2005 | inherited lipid metabolism disorder | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00079638 | Apr 2004 → May 2005 | atherosclerosis, coronary artery disorder, diabetes mellitus, hyperlipidemia +1 | Kos Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00317993 | Apr → Jul 2004 | — | University of Cologne | Completed | No outcome recorded |
| Phase 4 | NCT00687076 | Apr 2004 → Dec 2010 | peripheral arterial disease | Baylor College of Medicine | Completed | Missed primary |
| Phase 4 | NCT00651014 | Jan 2004 → Jun 2006 | atherosclerosis, hyperlipidemia | Organon and Co | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00650663 | Oct 2003 → Sep 2004 | atherosclerosis, hyperlipoproteinemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00653796 | Sep 2003 → Aug 2004 | atherosclerosis, hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00653835 | Sep 2003 → Aug 2004 | atherosclerosis, hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00652444 | Sep 2003 → Aug 2004 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00651274 | Apr 2003 → Aug 2004 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia | Organon and Co | Completed | Met primary |
| Phase not applicable29 trials · 1 met primary · 1 missed | ||||||
| — | NCT07704918 | Dec 2026 → Dec 2027 expected | melanoma | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| — | NCT07679828 | Jul 2026 → Dec 2029 expected | hyperlipidemia, hypertensive disorder, type 2 diabetes mellitus | China Medical University, China | Recruiting | No outcome recorded |
| — | NCT07626840 | Jun 2026 → Jun 2028 expected | acute coronary syndrome | Samsung Medical Center | Not yet recruiting | No outcome recorded |
| — | NCT07524101 | May 2026 → Jan 2031 expected | atherosclerosis, chronic kidney disease, hyperlipidemia | Yonsei University | Recruiting | No outcome recorded |
| — | NCT07359105 | Mar 2026 → Dec 2029 expected | type 2 diabetes mellitus | Sin Gon Kim | Recruiting | No outcome recorded |
| — | NCT07432516 | Feb 2026 → Jun 2033 expected | coronary artery disorder | Yonsei University | Not yet recruiting | No outcome recorded |
| — | NCT06896708 | Aug 2025 → Jul 2027 expected | coronary atherosclerosis | Liu yong | Recruiting | No outcome recorded |
| — | NCT06649240 | Oct 2024 → Sep 2030 expected | ischemic stroke, low density lipoprotein cholesterol, mild elevation of | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT06231966 | Apr 2024 → May 2026 overdue | peripheral arterial disease | Yonsei University | Recruiting | No outcome recorded |
| — | NCT06293417 | Mar 2024 → Feb 2027 expected | hyperlipidemia, type 2 diabetes mellitus | Korea University Anam Hospital | Recruiting | No outcome recorded |
| — | NCT05782777 | Apr 2023 → Dec 2027 expected | coronary artery disorder | Yonsei University | Recruiting | No outcome recorded |
| — | NCT05462262 | Oct 2022 → Jul 2029 expected | coronary atherosclerosis | Chinese Academy of Medical Sciences, Fuwai Hospital | Active not recruiting | No outcome recorded |
| — | NCT05624658 | Sep 2022 → May 2024 | hyperlipidemia | Samara Regional Cardiology Dispensary | Unknown | No outcome recorded |
| — | NCT05368545 | May 2020 → Apr 2024 | coronary artery disorder | Aarhus University Hospital | Completed | No outcome recorded |
| — | NCT03771053 | Jan 2018 → Mar 2019 | coronary artery disorder | Chinese PLA General Hospital | Unknown | No outcome recorded |
| — | NCT03044665 | Mar 2017 → Jan 2022 | cerebrovascular disorder, peripheral arterial disease | Yonsei University | Unknown | Met primary |
| — | NCT02942602 | Apr 2014 → May 2016 | hyperlipidemia | Yonsei University | Completed | No outcome recorded |
| — | NCT01584206 | Apr 2012 → Aug 2013 | sitosterolemia | University of Manitoba | Completed | No outcome recorded |
| — | NCT01241097 | Mar → Dec 2010 | — | Federal University of Bahia | Unknown | No outcome recorded |
| — | NCT00634140 | Aug 2009 | acalculous cholecystitis | Indiana University | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00955227 | Jul 2009 → May 2011 | hyperlipidemia | University of Manitoba | Completed | No outcome recorded |
| — | NCT02304926 | Jan 2009 → Dec 2011 | hyperlipidemia | FISABIO Foundation | Completed | No outcome recorded |
| — | NCT00879710 | Aug 2008 → Jul 2013 | hyperlipoproteinemia, type 1 diabetes mellitus, type 2 diabetes mellitus | Medical College of Wisconsin | Completed | No outcome recorded |
| — | NCT00725829 | Jun 2008 → Jun 2009 | acute coronary syndrome | Jagiellonian University | Unknown | No outcome recorded |
| — | NCT00485121 | Apr 2007 → Mar 2009 | coronary artery disorder, metabolic syndrome X, obesity disorder | Canadian Collaborative Research Network | Completed | No outcome recorded |
| — | NCT00475826 | Apr 2007 → ? | familial hypercholesterolemia | University of Sao Paulo | Unknown | No outcome recorded |
| — | NCT00587678 | Jan 2006 → Oct 2009 | peripheral arterial disease | University of Virginia | Completed | Missed primary |
| — | NCT00099684 | Nov 2005 → May 2007 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00461968 | Feb 2005 → Apr 2007 | low density lipoprotein cholesterol, mild elevation of | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Comparator or background therapy125 trials | ||||||
| Phase 1 | NCT06742853 Background | Dec 2024 → Oct 2025 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06547359 Comparator | Oct → Nov 2024 | — | NewAmsterdam Pharma | Completed | No outcome recorded |
| Phase 1 | NCT04895059 Comparator | Apr 2017 → Jan 2018 | — | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 1 | NCT02289430 Comparator | Dec 2014 → Feb 2015 | — | NVP Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02029625 Comparator | Feb → Mar 2014 | hyperlipidemia | NVP Healthcare | Completed | No outcome recorded |
| Show all 125 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 49
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Menarini Group | Regulatory Menarini Group and NewAmsterdam Pharma Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) menarini.com ↗ |
| 2026-09-21 | NewAmsterdam Pharma | Regulatory NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) newamsterdampharma.com ↗ |
| 2026-08-05 | NewAmsterdam Pharma | Regulatory NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results newamsterdampharma.com ↗
Our quarterly update is headlined by the positive opinion for Europe from CHMP, recommending the granting of a marketing authorization for Ubeslo and Evlarco, intended for the treatment of primary hypercholesterolemia or mixed dyslipidemia. |
| 2026-07-24 | Menarini Group | Regulatory NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) menarini.com ↗ |
| 2026-07-24 | NewAmsterdam Pharma | Regulatory NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination) newamsterdampharma.com ↗ |
| 2026-03-30 | Merck Sharp & Dohme LLC | Results MSD’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins msd.com ↗
In the study, treatment with enlicitide resulted in statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to bempedoic acid, ezetimibe or bempedoic acid with ezetimibe at eight weeks (day 56) of treatment. |
| 2025-09-02 | Menarini Group | Regulatory Menarini Group’s Obicetrapib and Obicetrapib/Ezetimibe Marketing Authorisation Applications Accepted for Review by the European Medicines Agency (EMA) for the Treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) menarini.com ↗ |
| 2025-06-16 | Daiichi Sankyo | Regulatory Anvisa aprova novo tratamento para colesterol alto daiichisankyo.com.br ↗
A Agência Nacional de Vigilância Sanitária (Anvisa) acaba de anunciar a aprovação do medicamento Nustendi® |
| 2025-04-28 | Hanmi Pharmaceutical Company Limited | Results 한미약품, SoLA 2025서 ‘저용량 로수젯’ 신규 임상 결과 발표 hanmi.co.kr ↗
한미약품은 지난 5일 서울드래곤시티 컨벤션센터에서 열린 ‘2025년 한국지질·동맥경화학회 춘계학술대회(2025 Spring Congress on Lipid and Atherosclerosis of KSoLA, SoLA 2025)’ 런천 심포지엄에 참가해 로수젯(Ezetimibe/Rosuvastatin)의 신규 임상 연구 결과를 발표했다고 28일 밝혔다. |
| 2025-02-10 | Hanmi Pharmaceutical Company Limited | Results “이상지질혈증 치료제 ‘로수젯’, 뇌졸중 환자에도 적합한 치료 옵션” hanmi.co.kr ↗
한미약품(대표이사 박재현)은 지난 5일부터 사흘간 미국 로스앤젤레스에서 열린 ‘2025 국제 뇌졸중 컨퍼런스(International Stroke Conference 2025, ISC2025)’에 참가해 로수젯(Ezetimibe/Rosuvastatin)의 새로운 임상 연구 결과를 발표했다고 10일 밝혔다. |
| 2024-10-02 | Esperion Therapeutics, Inc. | Results Esperion EU Partner Reports Final Real-World Results from MILOS German Cohort Demonstrating Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid esperion.com ↗
The results, presented in Hamburg, Germany at DGK Herztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice. |
| 2024-05-22 | Esperion Therapeutics, Inc. | Regulatory First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk esperion.com ↗
NILEMDO (bempedoic acid), a First-In-Class, Oral Treatment and NUSTENDI (bempedoic Acid / Ezetimibe Fixed-Dose Combination) Receive Label Update Approval from The European Commission as Treatments to Reduce Cardiovascular Risk by Lowering Low-Density Lipoprotein Cholesterol (LDL-C) Levels |
| 2024-04-22 | Hanmi Pharmaceutical Company Limited | Results “고지혈증 시장 1위 로수젯, 임상적 근거에 입각한 최적의 치료 옵션” hanmi.co.kr ↗ |
| 2024-03-22 | Esperion Therapeutics, Inc. | Regulatory CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events esperion.com ↗ |
| 2023-12-13 | Esperion Therapeutics, Inc. | Regulatory U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet esperion.com ↗
Esperion (NASDAQ: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for NEXLETOL and NEXLIZET to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. |
| 2023-11-03 | Hanmi Pharmaceutical Company Limited | Results “한미 ‘아모잘탄패밀리, 로수젯, 클로잘탄’, 임상적 유용성 뚜렷” hanmi.co.kr ↗ |
| 2023-06-28 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Submission of Application for Expanded Indication with the European Medicines Agency (EMA) for NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet esperion.com ↗
today announced that the application was filed for a Type II(a) variation with the European Medicines Agency (EMA) for the Company’s oral non-statin products marketed as NILEMDO and NUSTENDI in Europe. |
| 2023-06-01 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Submission of Supplemental New Drug Applications to U.S. FDA for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet esperion.com ↗
Esperion (NASDAQ: ESPR) today announced that it has submitted Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company’s oral non-statin products NEXLETOL and NEXLIZET. |
| 2022-10-04 | Hanmi Pharmaceutical Company Limited | Results 의료진이 주목한 한미 복합신약 ‘아모잘탄패밀리, 로수젯, 클로잘탄’ hanmi.co.kr ↗
심혈관질환에 의한 사망, 주요 심혈관계 사건 또는 비치명적 뇌졸중 발생에 있어 중강도 로수바스타틴과 에제티미브 복합제인 로수젯이 고용량 로수바스타틴 단일제 대비 비열등함을 입증했다 |
| 2022-04-13 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication of Phase 3 Data for Bempedoic Acid in the Journal of Clinical Lipidology esperion.com ↗
Analysis of pooled Phase 3 data demonstrated 26.5% reduction vs. placebo in LDL-C from bempedoic acid monotherapy and 39.2% reduction vs. placebo in LDL-C from bempedoic acid and ezetimibe fixed-dose combination in patients not taking statins |
| 2021-03-17 | Esperion Therapeutics, Inc. | Results NEXLETOL® (bempedoic acid) Tablet, ezetimibe and atorvastatin combination lowered bad cholesterol by 60.5% vs. placebo in Phase 2 study esperion.com ↗ |
| 2020-12-16 | Esperion Therapeutics, Inc. | Regulatory First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland esperion.com ↗ |
| 2020-04-07 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “LDL-C, 최대한 낮춰야”...로수젯, 최신 치료지침에 최적화 hanmi.co.kr ↗
연구 결과, 투여 8주 후 모든 용량에서 로수바스타틴 단일제 대비 로수젯 투여군이 ▲LDL-C(70mg/dL 미만) 도달률 ▲기저치 대비 50% 이상 감소 도달률 모두 우수한 것으로 확인됐다. |
| 2020-04-06 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
Esperion (NASDAQ: ESPR) announced today the European Commission approved the NUSTENDI™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. |
| 2020-03-28 | Esperion Therapeutics, Inc. | Results Esperion Announces Three Data Presentations of the NEXLETOL™ (bempedoic acid) Tablet and the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology esperion.com ↗
The poster highlighted that in the Phase 2 (1002-058) study, NEXLIZET significantly lowered LDL-Cholesterol (LDL-C) by a mean 40% compared to placebo, reduced high-sensitivity C-reactive protein (hsCRP) by 25% compared to baseline and resulted in no worsening of glycemic control. |
| 2020-02-26 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine esperion.com ↗
Esperion (NASDAQ:ESPR) today announced that the U.S. Food and Drug Administration (FDA) approved NEXLIZET™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C), lowering medicine. |
| 2020-02-17 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths. |
| 2020-01-31 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application for Bempedoic Acid for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
“This is the first Positive Regulatory Agency acceptance for an ACL inhibitor and for our medicines,” said Ashley Hall, chief development officer of Esperion. |
| 2020-01-31 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application for the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
Esperion (NASDAQ: ESPR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the MAA for the bempedoic acid / ezetimibe fixed dose combination tablet, recommending approval for the treatment of hypercholesterolemia and mixed dyslipidemia. |
| 2019-08-29 | Esperion Therapeutics, Inc. | Results Esperion Announces Positive Top-Line Results from Phase 2 Study of Bempedoic Acid / Ezetimibe Combination Tablet in Patients with Hypercholesterolemia and Type 2 Diabetes esperion.com ↗
Esperion (NASDAQ: ESPR) today announced positive top-line results from the Phase 2 bempedoic acid / ezetimibe combination tablet study (1002-058). |
| 2019-05-05 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review esperion.com ↗
Esperion (Nasdaq: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review. |
| 2019-04-24 | Hanmi Pharmaceutical Company Limited | Results <보도자료> “아모잘탄패밀리-로수젯, 고혈압ㆍ고지혈증의 확고한 치료 옵션” hanmi.co.kr ↗
이어 두 번째 연자로 나선 이무용 교수는 국내 이상지질혈증 환자 410명을 대상으로 진행한 로수젯 3상 임상 ‘MRS-ROZE’의 사후 분석 결과를 발표했다. |
| 2019-02-28 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Submissions of Two NDAs and Official Completion of Two MAA Validations for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet esperion.com ↗
Esperion also announced that the European Medicines Agency (EMA) has completed formal validation of Esperion’s two Marketing Authorization Applications (MAAs) and officially started the review procedure for both bempedoic acid and the bempedoic acid / ezetimibe combination tablet. |
| 2018-08-27 | Esperion Therapeutics, Inc. | Results Esperion Announces Positive Top-Line Results from Pivotal Phase 3 Bempedoic Acid / Ezetimibe Combination Pill Study esperion.com ↗
Esperion (NASDAQ: ESPR) today announced positive top-line results from the pivotal Phase 3 bempedoic acid / ezetimibe combination pill study (1002-053). |
| 2017-06-13 | Sun Pharmaceutical Industries, Inc. | Regulatory US FDA approval for generic Zetia® tablets sunpharma.com ↗ |
| 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. |
| 2016-02-15 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Complete Response Letter from the U.S. FDA for ZETIA® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. |
| 2015-11-27 | Hanmi Pharmaceutical Company Limited | Results <보도자료> ‘로수젯’ 런칭 심포지엄, 대구•부산 잇따라 개최 hanmi.co.kr ↗
한편, 한미약품이 국내 고지혈증 환자 410명을 대상으로 실시한 로수젯과 로수바스타틴 단일제를 투여한 3상에서는 로수젯이 단일제 대비 LDL-C, TG(Triglyceride, 중성지방) 감소율이 우월한 것으로 나타났다. |
| 2015-09-01 | Merck Sharp & Dohme LLC | Results New Analyses from the IMPROVE-IT Study with VYTORIN® (ezetimibe and simvastatin) merck.com ↗
Merck (NYSE:MRK), known as MSD in the United States and Canada, today announced results from new analyses from the IMPROVE-IT study. |
| 2015-06-03 | Merck Sharp & Dohme LLC | Results Results from Investigational IMPROVE-IT Study of VYTORIN® (ezetimibe and simvastatin) Published in the New England Journal of Medicine merck.com ↗
Merck (NYSE: MRK ), known as MSD outside the United States and Canada, today announced that the New England Journal of Medicine published the results of the IMPROVE-IT trial, an investigational study comparing treatment with VYTORIN ® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes. |
| 2015-03-16 | Merck Sharp & Dohme LLC | Results New Analysis from Investigational IMPROVE-IT Study Shows VYTORIN® (ezetimibe/simvastatin) Reduced Total (Initial and Recurrent) Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes merck.com ↗
VYTORIN reduced total events by 9% vs. simvastatin alone (incidence-rate ratio [IRR] 0.91, 95% CI 0.85-0.97, p=0.007). |
| 2014-11-17 | Merck Sharp & Dohme LLC | Results VYTORIN® (ezetimibe/simvastatin) Significantly Reduced Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes in the Investigational IMPROVE-IT Study merck.com ↗
In IMPROVE-IT, at seven years, 32.7 percent of patients taking VYTORIN experienced a primary endpoint event compared to 34.7 percent of patients taking simvastatin alone (hazard ratio of 0.936, p=0.016). |
| 2014-01-14 | Merck Sharp & Dohme LLC | Regulatory Merck Voluntarily Recalls All Lots of LIPTRUZET™ in the United States From Wholesalers Due to Packaging Defects merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling all lots of LIPTRUZET™ (ezetimibe and atorvastatin) 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets in the United States, including Puerto Rico, due to packaging defects. |
| 2013-05-03 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s LIPTRUZET™ (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. |
| 2013-01-02 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. |
| 2012-03-05 | Merck Sharp & Dohme LLC | Regulatory Merck Provides U.S. Regulatory Update on Investigational Ezetimibe/Atorvastatin Tablets merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s new drug application for ezetimibe and atorvastatin tablets, an investigational combination medicine. |
| 2012-01-25 | Merck Sharp & Dohme LLC | Regulatory New FDA Approved Labeling For VYTORIN® (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease merck.com ↗ |
| 2011-11-02 | Merck Sharp & Dohme LLC | Regulatory FDA Advisory Committee Unanimously Recommends Approval of Merck’s VYTORIN® (ezetimibe/simvastatin) for Use in Patients with Pre-Dialysis Chronic Kidney Disease merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck’s VYTORIN® (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease. |
| 2011-07-28 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical holds ‘Vytorin Together Symposium’ daewoong.co.kr ↗
Vytorin achieves 20% reduction of cardiovascular diseases in chronic renal patients |
All press releases naming this drug 67 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 395 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ezetimibe | “Preliminary data are also available data that the combination of statin to ezetimibe (EZE), a cholesterol absorption inhibitor, produces an additional decrease in LDL...” NCT00861731 ↗386“Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fed condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10...” NCT06050291 ↗ “This study will test the safety and effectiveness of SCH-58235 (Ezetimibe) in lowering sitosterol, plant sterol and cholesterol blood levels in patients with homozygous...” NCT00045812 ↗ “A total of 293 patients were randomly assigned into four groups receiving 2 mg pitavastatin, 4 mg pitavastatin, 2 mg pitavastatin/10 mg ezetimibe (K-924 LD), and 4 mg...” PMID 36908150 ↗ Mar 2023 “Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of...” NCT04433533 ↗ “Ezetimibe or PCSK-9 inhibitor may be considered in patients who could not achieve target LDL-cholesterol level even with the maximum dose of study drugs (atorvastatin 80mg) by...” NCT05361421 ↗ “Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual...” PMID 38775910 ↗ May 2024 “All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to...” PMID 22085343 ↗ Nov 2011 “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 ↗ “The initial recommended therapy is 20mg atorvastatin/10mg rosuvastatin plus Ezetimibe or PCSK9i, and the type and dosage of drugs can be adjusted according to the situation.” NCT06896708 ↗ “Participants received either 10-mg ezetimibe/5-mg atorvastatin (EZE10/ATV5), 10-mg ezetimibe (EZE10), 5-mg atorvastatin (ATV5), or 10-mg atorvastatin (ATV10).” PMID 40251695 ↗ Apr 2025 |
| Known as | Acotral | “Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of...” NCT01597700 ↗ |
| Known as | EZE | “The aim of this study was to evaluate whether the combination of low-dose statin (LDS) plus ezetimibe (EZE) or LDS plus nutraceutical (Armolipid Plus [ALP] containing red yeast...” PMID 30420184 ↗ Oct 20187“Combination of ezetimibe (EZE) with a statin represents an attractive strategy for cholesterol-lowering treatment, as it inhibits the two main sources of cholesterol:...” PMID 17407633 ↗ Apr 2007 “Preliminary data are also available data that the combination of statin to ezetimibe (EZE), a cholesterol absorption inhibitor, produces an additional decrease in LDL...” NCT00861731 ↗ “The purpose of this study was to examine the efficacy and safety of ezetimibe (EZE) coadministered with simvastatin (SIMVA) in a large cohort of African Americans with primary...” PMID 16749654 ↗ May 2006 “To assess if ezetimibe (EZE), a sterol-absorption inhibitor, improves platelet (PLT) count and size relative to its effect on plasma plant sterol (PS) in patients with...” PMID 25444527 ↗ Oct 2014 “Ezetimibe (EZE) is a cholesterol-lowering drug that inhibits absorption of dietary and biliary cholesterol” PMID 15811480 ↗ Feb 2005 “Bempedoic acid (BA)/ezetimibe (EZE) fixed dose combination (FDC) with rosuvastatin or atorvastatin” NCT07474649 ↗ “ezetimibe 10 mg (EZE)” PMID 27206943 ↗ Jan 2016 |
| Known as | Ezetimibe (Zetia) | “Ezetimibe (Zetia)” NCT02244944 ↗ |
| Known as | Ezetrol | “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 ↗2“administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15” NCT00810303 ↗ “Ezetrol (Ezetimibe)” NCT00926055 ↗ |
| Known as | MK0653 | “MK0653, ezetimibe / Duration of Treatment: 28 weeks” NCT00092716 ↗17“MK0653, ezetimibe / Duration of Treatment: 30 Weeks” NCT00551876 ↗ “MK0653, ezetimibe / Duration of Treatment: 27 Weeks” NCT00551447 ↗ “MK0653; ezetimibe / Duration of Treatment: 12 weeks” NCT00157911 ↗ “MK0653, ezetimibe / Duration of Treatment: 4 Weeks” NCT00457275 ↗ “MK0653, ezetimibe / Duration of Treatment: 6 Weeks” NCT00395473 ↗ “Ezetimibe (MK0653) 10 mg once daily for 3 years.” NCT00092833 ↗ “MK-0653, ezetimibe” NCT00328523 ↗ “MK0653, ezetimibe” NCT00092612 ↗ “MK0653, ezetimibe” NCT00092638 ↗ “MK0653, ezetimibe” NCT00092573 ↗ |
| Known as | SCH 58235 | “Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)” NCT03884452 ↗4“A Comparison of Treatment With Ezetimibe (SCH 58235) and Simvastatin Coadministration Versus Simvastatin” NCT00551447 ↗ |
| Known as | Zetia | “Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of...” NCT01597700 ↗5“Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)” NCT00079638 ↗ “Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients” NCT04508907 ↗ “Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]” NCT01043380 ↗ “Ezetimibe (Zetia) 10 mg per day” NCT02244944 ↗ “ezetimibe \[Zetia\]” NCT00477204 ↗ |
| Action | Inhibit | “Ezetimibe inhibits cholesterol absorption” PMID 23040830 ↗ Sep 2012 |
| Route | Oral | “take a 10-mg pill of ezetimibe daily” NCT00099996 ↗ |
| Target | NPC1L1 | “Recent studies suggest that NPC1L1 (Nieman-Pick C1 Like 1 protein) has a critical role in intestinal cholesterol absorption, being established as a direct target for the action...” NCT00481351 ↗ |