Drugs / Pravastatin
Pravastatin
also known as
Pravachol · Pravastatin sodium · C10AA03 · CS-514 · Dehypotin protect · Elisor · Eptastatin sodium · Lipemol · +12 more
Small molecule targets HMGCR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
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| Approved | EU (EMA) | Pravafenix | — | 2011-04-14 | europa.eu ↗ |
| Label expansions (10) | US (FDA) | PRAVACHOL | — | 1996-03-22 – 2007-02-28 | fda.gov ↗ |
| Approved | US (FDA) | PRAVACHOL | — | 1991-10-31 | fda.gov ↗ |
Trials 102 · started per year
today
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EU approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00702130 | Jun 2008 → Apr 2010 | — | University of Thessaly | Completed | No outcome recorded |
| Phase 130 trials · 1 met primary | ||||||
| Phase 1 | NCT06324396 | Mar 2024 → Dec 2026 expected | congenital cardiovascular shunt | Children's Mercy Hospital Kansas City | Recruiting | No outcome recorded |
| Phase 1 | NCT07838987 | Dec 2023 → Jun 2026 | — | Terns, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05852769 | May → Aug 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05524246 | Jan 2023 → Dec 2024 | disease related to hematopoietic stem cell transplant, endotheliitis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT04425902 | Dec 2020 → Mar 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04608344 | Nov 2020 → Jan 2021 | rheumatoid arthritis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT04092751 | Nov → Dec 2019 | — | Scynexis, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03801733 | Jun → Nov 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03131973 | May → Nov 2017 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02621957 | Dec 2015 → Feb 2016 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02547402 | Dec 2015 → Jan 2016 | acute kidney injury | Complexa, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02578277 | Nov → Dec 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02456844 | May → Jul 2015 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02484261 | May 2015 → May 2018 | leukemia | Reuven Schore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02360826 | Jun 2014 → Jul 2016 | — | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 1 | NCT02045966 | Feb → Apr 2014 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01958489 | Oct 2013 → Jan 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01934569 | Sep → Nov 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01845428 | May 2012 → Jan 2017 | hyperlipidemia, nephrotic syndrome | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT01788254 | Jan 2012 → May 2015 | — | Matthias Schwab | Completed | No outcome recorded |
| Phase 1 | NCT01254461 | Feb → Apr 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01845194 | Dec 2009 → Oct 2013 | mitochondrial membrane transport disorder | Institute of Application-oriented Research and Clinical Trials GmbH | Completed | No outcome recorded |
| Phase 1 | NCT00571194 | Sep 2007 → May 2009 | end stage renal failure | Arkansas Children's Hospital Research Institute | Terminated | No outcome recorded |
| Phase 1 | NCT00830258 | Apr 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00107523 | Jan → Oct 2005 | leukemia | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00039663 | May 2002 → Oct 2005 | HIV infectious disease | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT00834379 | Sep 2000 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00834847 | Aug → Sep 2000 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00017758 | — | HIV infectious disease, lipodystrophy | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000941 | ? → Mar 2002 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06553157 | Sep 2024 → Jul 2025 | cancer, platinum-induced ototoxicity | Minia University | Completed | No outcome recorded |
| Phase 1/2 | NCT01342887 | Apr 2011 → Mar 2012 | acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +8 | Fred Hutchinson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT00467831 | Apr 2007 → Nov 2012 | Hermansky-Pudlak syndrome, oculocutaneous albinism, platelet storage pool deficiency, pulmonary fibrosis | National Human Genome Research Institute (NHGRI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 220 trials · 2 met primary | ||||||
| Phase 2 | NCT07098975 | Jan 2026 → Nov 2027 expected | fetal growth restriction, placental insufficiency, preeclampsia | Sant Pau Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07217938 | Dec 2025 → Oct 2028 expected | head and neck cancer | Peter MacCallum Cancer Centre, Australia | Recruiting | No outcome recorded |
| Phase 2 | NCT06494111 | Feb 2025 → May 2029 expected | lymphedema | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04190433 | Sep 2020 → Apr 2023 | breast carcinoma, lymphoma, sarcoma | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03456102 | Mar 2020 → Aug 2022 | tuberculosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT03882177 | Feb 2020 → May 2022 | pulmonary tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT03219372 | Sep → Dec 2018 | cirrhosis of liver, hepatocellular carcinoma | Cedars-Sinai Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03648970 | Mar 2018 → Mar 2020 | preeclampsia | Universitas Airlangga | Unknown | No outcome recorded |
| Phase 2 | NCT01357486 | Nov 2011 → Apr 2017 | hepatocellular carcinoma | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 2 | NCT01515813 | Nov 2011 → Jul 2014 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Withdrawn | No outcome recorded |
| Phase 2 | NCT01268202 | Dec 2010 → Apr 2019 | — | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT00840177 | Dec 2009 → Dec 2018 | leukemia | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00916747 | Aug 2009 → Feb 2022 | Hutchinson-Gilford progeria syndrome | Boston Children's Hospital | Unknown | Met primary |
| Phase 2 | NCT00879034 | Mar → Apr 2009 | Hutchinson-Gilford progeria syndrome | Boston Children's Hospital | Completed | Met primary |
| Phase 2 | NCT00731016 | Oct 2008 → Apr 2013 | Hutchinson-Gilford progeria syndrome | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| Phase 2 | NCT00305201 | Apr 2006 → May 2007 | Kawasaki disease | Pontificia Universidad Catolica de Chile | Withdrawn | No outcome recorded |
| Phase 2 | NCT00166036 | Sep 2004 → Mar 2008 | diabetes mellitus, hyperlipoproteinemia, metabolic syndrome X | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT00054938 | Mar 2003 → Dec 2005 | systemic lupus erythematosus | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00221754 | Mar 2003 → Mar 2004 | HIV infectious disease, hyperlipidemia | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 2 | NCT00000461 | Dec 1986 → Nov 1992 | coronary artery disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 315 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT04385433 | Dec 2020 → Apr 2023 | breast cancer | Institut du Cancer de Montpellier - Val d'Aurelle | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03944512 | Jul 2019 → Jun 2021 | preeclampsia | The George Washington University Biostatistics Center | Terminated | Missed primary |
| Phase 3 | NCT02166593 | May 2014 → Jan 2018 | hyperlipidemia, combined, 2 | Yooyoung Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01903694 | Mar 2010 → Nov 2013 | hepatocellular carcinoma | Centre Hospitalier Universitaire Dijon | Completed | Missed primary |
| Phase 3 | NCT01075555 | Feb 2010 → Sep 2015 | liver cancer | Federation Francophone de Cancerologie Digestive | Completed | No outcome recorded |
| Phase 3 | NCT00459745 | Apr 2007 → Apr 2008 | hyperlipidemia, combined, 2 | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT00433498 | Jan 2007 → Jan 2012 | small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 3 | NCT00456365 | Nov 2006 → Oct 2012 | autosomal dominant polycystic kidney disease | University of Colorado, Denver | Completed | Met primary |
| Phase 3 | NCT00214604 | Feb 2005 → Feb 2007 | hyperlipoproteinemia type 3 | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00132717 | Jan 2005 → Jun 2007 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00200655 | Dec 2004 → Nov 2007 | relapsing-remitting multiple sclerosis | Nantes University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03073018 | Apr 1998 → Jun 2003 | cardiovascular disorder, proteinuria | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 3 | NCT00000542 | Aug 1993 → Mar 2002 | coronary artery disorder, diabetes mellitus, heart failure, hyperlipidemia +3 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 3 | NCT00006412 | ? → May 2003 | HIV infectious disease, lipodystrophy | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00005010 | ? → Mar 2004 | chronic transplant rejection, end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 423 trials · 3 met primary · 1 missed | ||||||
| Phase 4 | NCT06856772 | Feb 2025 → Mar 2028 expected | atherosclerotic cardiovascular disease | Tor Biering-Sørensen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06785727 | Feb 2025 → Dec 2028 expected | transient ischemic attack | Prof. dr. Nathalie van der Velde | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06357104 | Feb → Mar 2024 | — | Pachankis, Yang I., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT04719481 | Nov 2021 | postmenopausal osteoporosis | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04640571 | Apr → Nov 2021 | — | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT02992548 | Sep 2015 → Dec 2018 | chronic kidney disease | Dong-A University | Completed | No outcome recorded |
| Phase 4 | NCT02754739 | Apr 2014 → Aug 2017 | diabetes mellitus, prediabetes syndrome | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01563731 | Apr 2013 → Dec 2020 | hypertensive disorder, transient ischemic attack | Istituto Auxologico Italiano | Completed | No outcome recorded |
| Phase 4 | NCT01038154 | Nov 2009 → Nov 2011 | esophageal cancer, gastric cancer | Hospital Donostia | Unknown | No outcome recorded |
| Phase 4 | NCT00688922 | Jul 2008 → Jun 2010 | acute myocardial infarction | Osaka Acute Coronary Insufficiency Study Group | Unknown | No outcome recorded |
| Phase 4 | NCT00630734 | Feb 2008 → Oct 2009 | HIV infectious disease, hyperlipidemia | University of Colorado, Denver | Completed | Missed primary |
| Phase 4 | NCT00402376 | Apr 2007 → ? | heart failure | University Hospital, Strasbourg, France | Terminated | No outcome recorded |
| Phase 4 | NCT00405717 | Feb 2006 → May 2008 | acute coronary syndrome | Shenyang Northern Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00652327 | Dec 2005 → Jul 2007 | hyperlipidemia | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00117494 | Oct 2005 → Mar 2007 | HIV infectious disease, hyperlipidemia | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 4 | NCT00177580 | Jul 2003 → Jan 2007 | schizoaffective disorder, schizophrenia | University of Pittsburgh | Completed | No outcome recorded |
| Phase 4 | NCT00529178 | Dec 2002 → Mar 2005 | hyperlipidemia | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT00227500 | Jul 2001 → Oct 2004 | HIV infectious disease, cardiovascular disorder, glucose metabolism disease, lipodystrophy | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT00384618 | May 2001 → Aug 2005 | chronic kidney disease | Amsterdam UMC, location VUmc | Terminated | Met primary |
| Phase 4 | NCT00382460 | Nov 2000 → Dec 2003 | acute coronary syndrome | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT00330980 | Apr 2000 → Mar 2004 | hyperlipidemia | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT00380939 | Apr 1999 → Dec 2000 | coronary atherosclerosis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00211705 | Feb 1994 → Mar 2004 | hyperlipidemia | Mitsukoshi Health and Welfare Foundation | Completed | Met primary |
| Phase not applicable10 trials · 1 missed | ||||||
| — | NCT07704918 | Dec 2026 → Dec 2027 expected | melanoma | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| — | NCT02079974 | Jul 2014 | endometriosis | Dr. Robert F. Casper | Withdrawn | No outcome recorded |
| — | NCT01872845 | Jun 2013 → May 2017 | coronary artery disorder | Yonsei University | Completed | No outcome recorded |
| — | NCT01831232 | May 2013 → Feb 2015 | acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +11 | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| — | NCT01634906 | Jul 2012 → Mar 2013 | atherosclerosis, hyperlipidemia | Sint Franciscus Gasthuis | Completed | No outcome recorded |
| — | NCT01259791 | Sep 2010 → Aug 2013 | statin toxicity | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | Missed primary |
| — | NCT00982189 | Sep 2009 → Dec 2010 | HIV infectious disease, cardiovascular disorder | Hennepin Healthcare Research Institute | Completed | No outcome recorded |
| — | NCT00464503 | Sep → Oct 2007 | statin toxicity | University of Antwerp | Completed | No outcome recorded |
| — | NCT00599625 | Oct 2004 → Dec 2011 | Crohn disease | University of Virginia | Unknown | No outcome recorded |
| — | NCT00005117 | — | heart disorder | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Comparator or background therapy64 trials | ||||||
| Phase 1 | NCT02871687 Comparator | Apr 2016 → Mar 2021 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02431013 Comparator | Apr → Aug 2015 | hyperlipidemia, peripheral arterial disease | Ajou University School of Medicine | Unknown | No outcome recorded |
| Phase 1 | NCT01717586 Comparator | Aug 2012 → Feb 2024 | preeclampsia | The University of Texas Medical Branch, Galveston | Completed | No outcome recorded |
| Phase 1 | NCT01497483 Comparator | Dec 2011 → May 2013 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00665717 Comparator | May → Sep 2008 | HIV infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00829309 Comparator | Mar 2005 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT02229773 Comparator | Jan → May 2000 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02266485 Comparator | Jul → Sep 1998 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT04356209 Background | Jan 2020 → Jan 2026 overdue | breast cancer | Institut du Cancer de Montpellier - Val d'Aurelle | Recruiting | No outcome recorded |
| Phase 2 | NCT04284657 Comparator | Jan 2019 → Aug 2025 | autosomal dominant polycystic kidney disease | University of Southern California | Completed | No outcome recorded |
| Phase 2 | NCT02841774 Comparator | Nov 2016 → Jun 2021 | HIV infectious disease, coronary artery disorder | Matthew Feinstein | Completed | No outcome recorded |
| Phase 2 | NCT02072161 Background | Mar 2014 → Jan 2015 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01972178 Background | Nov 2013 → Jul 2014 | hyperlipidemia | Pronova BioPharma | Terminated | No outcome recorded |
| Phase 2 | NCT01890967 Background | Jun 2013 → Apr 2014 | hyperlipoproteinemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01418729 Comparator | Sep 2011 → Dec 2015 | hepatocellular carcinoma | Hospital Donostia | Completed | No outcome recorded |
| Phase 2 | NCT00639223 Comparator | Jan → Jul 2008 | hyperlipidemia, statin toxicity | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00697203 Background | Jul 2005 → May 2006 | hyperlipidemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00688896 Comparator | Jun 2002 → Apr 2003 | hyperlipidemia | Akros Pharma Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT05565976 Background | Aug 2020 → Dec 2024 | cognitive impairment with or without cerebellar ataxia, ischemic stroke, metabolic syndrome X, vascular dementia | Jaime Daniel Mondragon | Unknown | No outcome recorded |
| Phase 3 | NCT03510715 Background | Aug 2018 → Feb 2020 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03510884 Background | May 2018 → Jan 2021 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT02107898 Background | Mar 2014 → Jan 2015 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT00738972 Comparator | Jan 2008 → Aug 2010 | hypertensive disorder | Fundación Lindavista del Corazón AC | Terminated | No outcome recorded |
| Phase 3 | NCT00532311 Comparator | Jul 2007 → Apr 2008 | hyperlipidemia | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00362206 Comparator | Sep 2006 → Sep 2008 | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00257686 Comparator | Sep 2005 → May 2006 | hyperlipidemia | Kowa Research Europe | Completed | No outcome recorded |
| Phase 3 | NCT00221104 Comparator | Mar 2004 → Jul 2014 | ischemic stroke | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 3 | NCT00361530 Comparator | Mar 2004 → Jul 2014 | ischemic stroke | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 3 | NCT00361699 Comparator | Mar 2004 → Jul 2014 | ischemic stroke | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 3 | NCT00127218 Background | Sep 2003 → Dec 2008 | atherosclerosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 3 | NCT00654537 Comparator | Apr 2001 → Oct 2004 | familial hypercholesterolemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01057654 Comparator | Jan → Apr 1996 | hyperlipidemia, hyperlipoproteinemia | University Hospital, Bonn | Completed | No outcome recorded |
| Phase 3 | NCT00000539 Background | Sep 1992 → Mar 1999 | arterial occlusion, diabetes mellitus, heart disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 4 | NCT03273413 Comparator | Aug 2017 → Mar 2024 overdue | autosomal dominant polycystic kidney disease | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04061824 Comparator | May 2016 → Dec 2018 | hyperlipidemia, hypertensive disorder | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01715714 Comparator | Nov 2012 → Apr 2019 | coronary artery disorder | University of Cologne | Completed | No outcome recorded |
| Phase 4 | NCT01816997 Comparator | Jan 2012 → Dec 2017 | diabetes mellitus | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT01856374 Comparator | Aug 2011 → Mar 2014 | intermediate coronary syndrome | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01502943 Background | May → Dec 2011 | intermediate coronary syndrome | Liaoning University of Traditional Chinese Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01325818 Comparator | Mar 2011 | coronary artery disorder, hyperlipoproteinemia | Yokohama City University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01301066 Comparator | Dec 2010 → Mar 2013 | hyperlipidemia | Kowa Research Institute, Inc. | Completed | Met primary |
| Phase 4 | NCT01256476 Comparator | Oct 2010 → Jun 2011 | hyperlipidemia, combined, 2 | Kowa Research Institute, Inc. | Completed | Met primary |
| Phase 4 | NCT01557075 Comparator | Jul 2010 → Aug 2015 | — | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01502904 Comparator | Jul 2010 → May 2015 | myocardial ischemia | Yonsei University | Completed | Met primary |
| Phase 4 | NCT01293097 Background | Jun 2010 → Oct 2011 | acute coronary syndrome, myocardial infarction | Peking University First Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01082588 Comparator | Jun 2010 → Sep 2012 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01004237 Comparator | Nov 2009 → Apr 2012 | hypertensive disorder | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01857843 Comparator | Nov 2009 → Nov 2013 | acute coronary syndrome | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00843661 Comparator | Mar 2009 → Dec 2011 | HIV infectious disease, hyperlipidemia | Ospedale di Circolo - Fondazione Macchi | Unknown | No outcome recorded |
| Phase 4 | NCT02305355 Background | Feb 2009 → Feb 2011 | hypertriglyceridemia, type 2 diabetes mellitus | Kuhnil Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 4 | NCT00850460 Comparator | Feb 2009 → Feb 2013 | statin toxicity | Rockefeller University | Terminated | No outcome recorded |
| Phase 4 | NCT00701285 Comparator | Jul 2008 → May 2013 | congestive heart failure | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00631189 Comparator | Oct 2007 → Oct 2008 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00549926 Comparator | Oct 2007 → Feb 2010 | coronary artery disorder, hyperlipidemia | Yokohama City University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00738296 Comparator | Apr → Dec 2005 | cardiovascular disorder | Hospital Universitario 12 de Octubre | Completed | No outcome recorded |
| Phase 4 | NCT00755352 Background | Nov 2002 → Jun 2003 | hyperlipidemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00303277 Comparator | Aug 2002 → Apr 2005 | Alzheimer disease | Seattle Institute for Biomedical and Clinical Research | Completed | No outcome recorded |
| — | NCT05251129 Comparator | Jan 2025 → Jun 2030 | vascular disorder | Montefiore Medical Center | Withdrawn | No outcome recorded |
| — | NCT03127631 Comparator | Oct 2015 → Dec 2026 expected | cardiovascular disorder, prostate cancer | McMaster University | Active not recruiting | No outcome recorded |
| — | NCT02155530 Comparator | Jun 2014 → May 2016 | coronary artery disorder | Yonsei University | Completed | No outcome recorded |
| — | NCT01441908 Comparator | Jun 2011 → Apr 2012 | hyperlipidemia | MaiHealth Inc | Unknown | No outcome recorded |
| — | NCT01857921 Comparator | Dec 2010 → Apr 2018 | coronary artery disorder | Yonsei University | Completed | No outcome recorded |
| — | NCT01173939 Comparator | Jul 2010 → Jun 2014 | hyperlipoproteinemia, hypertensive disorder, type 2 diabetes mellitus | Positive Trial Group | Terminated | No outcome recorded |
| — | NCT00794963 Background | Nov 2008 → May 2010 | metabolic syndrome X | Northwell Health | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2013-06-17 | Eli Lilly and Company | Results New Data Showed LIVALO® (pitavastatin) 4 mg had Neutral Effects on Fasting Serum Glucose and HbA1c Levels in HIV-infected Adults with Dyslipidemia lilly.com ↗
The results of this pre-specified safety analysis, presented yesterday at the Endocrine Society's 95th Annual Meeting & Expo in San Francisco, CA, showed neutral effects of pitavastatin 4 mg and pravastatin 40 mg on fasting serum glucose (FSG) and HbA1c levels over 12 weeks. |
| 2013-03-07 | Eli Lilly and Company | Results New Superiority Trial Showed LIVALO® (pitavastatin) 4 mg Provided Significantly Greater LDL-C Reduction in HIV-Infected Adults with Dyslipidemia versus Pravastatin 40 mg lilly.com ↗
Results showed that, after 12 weeks of therapy, pitavastatin had a significantly greater decrease in LDL-C compared with pravastatin (pitavastatin -49.4 mg/dL and pravastatin -33.6 mg/dL, 31% vs 21% reduction in LDL-C, respectively, p < 0.001). |
| 2012-05-31 | Eli Lilly and Company | Results New Data Showed LIVALO® (pitavastatin) Met Primary Endpoint of LDL-C Reduction When Compared with Pravastatin lilly.com ↗
LIVALO 4 mg showed superior LDL-C reduction compared with pravastatin 40 mg after 12 weeks of therapy. |
| 2008-02-01 | Daiichi Sankyo | Results Analytical Results for Women from Large Scale Clinical Trial MEGA Study Employing the Hypercholesterolemia Drug Mevalotin(R) Published daiichisankyo.com ↗
Mevalotin(R) Lowers the Risk of Cardiovascular Disease for Postmenopausal Women |
| 2008-01-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Pravastatin Sodium Tablets, 80 Mg tevapharm.com ↗
Jerusalem, Israel, January 17, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Pravastatin Sodium Tablets, 80 mg. |
| 2006-04-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives First FDA Approval for Generic Pravachol®; Appellate Court Denies Apotex Request for Injunctive Relief tevapharm.com ↗
Today's approval follows an order by the U.S. Court of Appeals for the DC Circuit dissolving an administrative injunction issued April 20, 2006 and denying Apotex's motion for injunctive relief pending appeal. |
| 2006-04-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Stay of Approval for Generic Pravachol Lifted tevapharm.com ↗
the Court has granted that motion and vacated the stay of approval. |
| 2006-04-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Determination that Generic Pravachol Exclusivity Has Not Been Triggered tevapharm.com ↗
The July 23, 2004 Apotex-Bristol dismissal does not contain such a holding. |
| 2005-11-17 | Daiichi Sankyo | Results Large Scale Clinical Trial MEGA Study* Employing the Hyperlipidemia Drug Mevalotin® daiichisankyo.com ↗
Onset of coronary artery disease was significantly suppressed by 33% (p=0.010). |
| 2005-07-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Comments On Fda Letter Regarding Pravastatin Exclusivity tevapharm.com ↗
Teva will immediately pursue legal action to obtain reversal of the decision. |
| 2002-05-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative FDA Approval for Pravastatin Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted tentative approval for the company's ANDA for Pravastatin Sodium Tablets, 10 mg, 20 mg and 40 mg. |
All press releases naming this drug 17 releases
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 167 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pravastatin | “One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824 ↗162“Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20...” NCT00850460 ↗ “Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin)...” NCT02578277 ↗ “Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin...” NCT02072161 ↗ “Cocktail = Caffeine 200 mg, Metoprolol 50 mg, Montelukast 10 mg, Flurbiprofen 50 mg, Omeprazole 40 mg, Midazolam 5 mg, Digoxin 0.25 mg, and Pravastatin 40 mg” NCT02045966 ↗ “Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.” NCT02107898 ↗ “can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously” NCT01259791 ↗ “patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor” NCT01502943 ↗ “Statins include atorvastatin , fluvastatin , lovastatin , pitavastatin , pravastatin, rosuvastatin and simvastatin.” NCT06553157 ↗ “Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects” NCT04092751 ↗ “Daily pravastatin (40mg/d) during 12 months (pravastatin initiation: first day of radiotherapy).” NCT04385433 ↗ |
| Known as | C10AA03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | CS-514 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Dehypotin protect | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Elisor | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Eptastatin sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Lipemol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Liplat | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Lipostat | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | mevalotin | “2. Pravastatin 20mg (mevalotin®, BMS)” NCT01857843 ↗ |
| Known as | NSC-759253 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Pravachol | “The two statins that will be used in this study, pravastatin (Pravachol ®) and atorvastatin (Lipitor®), are approved for use in people with a high cholesterol level or heart disease.” NCT00166036 ↗ |
| Known as | Pravasine | “Pravastatin-Pravasine” NCT00464503 ↗ |
| Known as | Pravastatin (Mevalotin) | “Pravastatin (Mevalotin)” NCT01816997 ↗ |
| Known as | pravastatin (Pravachol) | “pravastatin (Pravachol)” NCT00127218 ↗ |
| Known as | Pravastatin sodium | “Pravastatin sodium is a medication that is approved by the Food and Drug Administration (FDA) for treating high cholesterol.” NCT01515813 ↗ |
| Known as | Pravastatin sodium component of pravigard pac | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Pravastatina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Pravastatine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | Pravator | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Known as | SQ-31,000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1144 ↗ |
| Action | Inhibit | “pravastatin (a HMG CoA reductase inhibitor)” NCT00000542 ↗ |
| Modality | Small molecule | “Statin” NCT00384618 ↗ |
| Route | Oral | “Patients receive oral pravastatin once daily” NCT00107523 ↗ |
| Target | HMGCR | “Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor” NCT01038154 ↗ |