Pravastatin

also known as Pravachol · Pravastatin sodium · C10AA03 · CS-514 · Dehypotin protect · Elisor · Eptastatin sodium · Lipemol · +12 more

Small molecule targets HMGCR via inhibition

Developed for: hyperlipidemia · cardiovascular disorder · coronary artery disorder · diabetes mellitus · hepatocellular carcinoma · Hutchinson-Gilford progeria syndrome · leukemia · lipodystrophy
+65 more
· preeclampsia · acute coronary syndrome · acute erythroid leukemia · acute megakaryoblastic leukemia in adult · acute myeloblastic leukemia with maturation · acute myeloblastic leukemia without maturation · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with minimal differentiation · acute myeloid leukemia with t(8;21)(q22;q22) translocation · acute myeloid leukemia, del(5q31-q32) · acute myeloid leukemia, inv(16)(p13.1;q22) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute myelomonocytic leukemia M4 · adult acute monocytic leukemia · breast cancer · chronic kidney disease · end stage renal failure · heart failure · hyperlipidemia, combined, 2 · hypertensive disorder · myocardial ischemia · statin toxicity · transient ischemic attack · acute myocardial infarction · atherosclerotic cardiovascular disease · autosomal dominant polycystic kidney disease · chronic myelomonocytic leukemia · chronic transplant rejection · coronary atherosclerosis · Crohn disease · endometriosis · endotheliitis · esophageal cancer · fetal growth restriction · gastric cancer · heart disorder · hyperlipoproteinemia · hyperlipoproteinemia type 3 · Kawasaki disease · liver cancer · lymphedema · metabolic syndrome X · myelodysplastic syndrome with excess blasts · myeloproliferative neoplasm, unclassifiable · nephrotic syndrome · placental insufficiency · platinum-induced ototoxicity · prediabetes syndrome · proteinuria · pulmonary fibrosis · pulmonary tuberculosis · relapsing-remitting multiple sclerosis · schizoaffective disorder · schizophrenia · small cell lung carcinoma · systemic lupus erythematosus · tuberculosis · Alzheimer disease · congestive heart failure · familial hypercholesterolemia · intermediate coronary syndrome · ischemic stroke · metabolic disease · type 2 diabetes mellitus · vascular disorder
Investigated by: Bristol-Myers Squibb · National Institute of Allergy and Infectious Diseases (NIAID) · National Cancer Institute (NCI) · National Heart, Lung, and Blood Institute (NHLBI) · Fred Hutchinson Cancer Center · Teva Pharmaceuticals USA
+114 more
· University of Colorado, Denver · American Heart Association · AstraZeneca · Boston Children's Hospital · Brigham and Women's Hospital · Centre Hospitalier Universitaire Dijon · Children's Mercy Hospital Kansas City · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Federation Francophone de Cancerologie Digestive · Merck Sharp & Dohme LLC · Ministry of Health, France · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Organon and Co · Pfizer · Schering-Plough · University Hospital, Bordeaux · ViiV Healthcare · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Akebia Therapeutics · American College of Gastroenterology · Amsterdam UMC, location VUmc · Arkansas Children's Hospital Research Institute · Assistance Publique Hopitaux De Marseille · Cedars-Sinai Medical Center · Children's Hospital Medical Center, Cincinnati · Chinese Hypertension League · Clinical Network Services (CNS) Pty Ltd · Complexa, Inc. · Daiichi Sankyo · Daiichi Sankyo Korea Co., Ltd. · Dana-Farber Cancer Institute · Dong-A University · Dr. Robert F. Casper · Dutch Kidney Foundation · Eiger BioPharmaceuticals · Eli Lilly and Company · Emory University · European Society of Hypertension · First Affiliated Hospital of Chongqing Medical University · French National Agency for Research on AIDS and Viral Hepatitis · French National Institute of Health and Medical Research · Garvan Institute of Medical Research · Genentech, Inc. · Gilead Sciences · Gustave Roussy, Cancer Campus, Grand Paris · Hennepin Healthcare Research Institute · Herlev and Gentofte Hospital · Hospital Clinic of Barcelona · Hospital Donostia · Hospital Universitari Vall d'Hebron Research Institute · Hyundai Hope On Wheels · Indiana Clinical and Translational Sciences Institute · Institut de Physiologie, Strasbourg, France · Institut du Cancer de Montpellier - Val d'Aurelle · Institute of Application-oriented Research and Clinical Trials GmbH · Integrium · Istituto Auxologico Italiano · Johns Hopkins University · Kirby Institute · Lakefront Biotherapeutics NV · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · M.D. Anderson Cancer Center · Matthias Schwab · Mayo Clinic · Medical Research Foundation, The Netherlands · Millennium Pharmaceuticals, Inc. · Minia University · Minia University Hospital · Ministry of Health, Labour and Welfare, Japan · Mitsukoshi Health and Welfare Foundation · Nantes University Hospital · National Center for Research Resources (NCRR) · National Human Genome Research Institute (NHGRI) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · all 120 on the full record

Regulatory milestones approvals, filings & regulatory actions · 15 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Pravafenix	—	2011-04-14	europa.eu ↗
Label expansions (13)	US (FDA)	PRAVACHOL	—	1996-03-22 – 2007-02-28	fda.gov ↗
Approved	US (FDA)	PRAVACHOL	—	1991-10-31	fda.gov ↗

Trials 101 · started per year

today

US approved 1991

EU approved 2011

19861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

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 129 trials
Phase 1	NCT06324396	Mar 2024 → Dec 2026 expected	congenital cardiovascular shunt	Children's Mercy Hospital Kansas City	Recruiting	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	NCT02547402	Dec 2015 → Jan 2016	acute kidney injury	Complexa, Inc.	Completed	No outcome recorded
Phase 1	NCT02621957	Dec 2015 → Feb 2016	breast cancer	Genentech, 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
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	No outcome recorded
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	NCT00000941	? → Mar 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00017758	—	HIV infectious disease, lipodystrophy	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 1/23 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
Phase 220 trials
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
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
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	No outcome recorded
Phase 2	NCT00879034	Mar → Apr 2009	Hutchinson-Gilford progeria syndrome	Boston Children's Hospital	Completed	No outcome recorded
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
Phase 3	NCT04385433	Dec 2020 → Apr 2023	breast cancer	Institut du Cancer de Montpellier - Val d'Aurelle	Terminated	No outcome recorded
Phase 3	NCT03944512	Jul 2019 → Jun 2021	preeclampsia	The George Washington University Biostatistics Center	Terminated	No outcome recorded
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	No outcome recorded
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	No outcome recorded
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	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 3	NCT00006412	? → May 2003	HIV infectious disease, lipodystrophy	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 423 trials
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	No outcome recorded
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	No outcome recorded
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	No outcome recorded
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	No outcome recorded

Phase not applicable10 trials
—	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	No outcome recorded
—	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

Also used as a comparator or background therapy in 64 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 18 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 210 trials
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 2/31 trial
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 314 trials
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	No outcome recorded
Phase 3	NCT02107898 Background	Mar 2014 → Jan 2015	hyperlipidemia	Sanofi	Completed	No outcome recorded
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	NCT00361699 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	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 424 trials
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	No outcome recorded
Phase 4	NCT01256476 Comparator	Oct 2010 → Jun 2011	hyperlipidemia, combined, 2	Kowa Research Institute, Inc.	Completed	No outcome recorded
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	No outcome recorded
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	NCT00850460 Comparator	Feb 2009 → Feb 2013	statin toxicity	Rockefeller University	Terminated	No outcome recorded
Phase 4	NCT02305355 Background	Feb 2009 → Feb 2011	hypertriglyceridemia, type 2 diabetes mellitus	Kuhnil Pharmaceutical Co., Ltd.	Completed	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

Phase not applicable7 trials
—	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

Press releases naming this drug 14 releases

Date	Issuer	Release
2008-02-01	Daiichi Sankyo	Analytical Results for Women from Large Scale Clinical Trial MEGA Study Employing the Hypercholesterolemia Drug Mevalotin(R) Published daiichisankyo.com ↗
2008-01-17	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Approval Of Pravastatin Sodium Tablets, 80 Mg tevapharm.com ↗
2006-04-25	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Receives First FDA Approval for Generic Pravachol®; Appellate Court Denies Apotex Request for Injunctive Relief tevapharm.com ↗
2006-04-23	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Provides Update on Generic Pravachol® tevapharm.com ↗
2006-04-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Stay of Approval for Generic Pravachol Lifted tevapharm.com ↗
2006-04-19	Teva Branded Pharmaceutical Products R&D, Inc.	District Court Denies Apotex's Request to Block Teva's Introduction of First Generic Pravachol® in the U.S.; Court Grants Stay of FDA Approval until After Close of Business Friday tevapharm.com ↗
2006-04-12	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Determination that Generic Pravachol Exclusivity Has Not Been Triggered tevapharm.com ↗
2006-03-16	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Provides Update on Generic Pravachol Exclusivity tevapharm.com ↗
2006-02-17	Daiichi Sankyo	Future Business Prospects of the Hyperlipidemia Drug Pravastatin in the United States daiichisankyo.com ↗
2005-11-17	Daiichi Sankyo	Large Scale Clinical Trial MEGA Study* Employing the Hyperlipidemia Drug Mevalotin® daiichisankyo.com ↗
2005-10-21	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Receives Favorable Court Ruling on Generic Pravachol® Exclusivity tevapharm.com ↗
2005-10-14	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Receives Favorable Ruling From Japanese Patent Office Regarding Pravastatin tevapharm.com ↗
2005-07-06	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Comments On Fda Letter Regarding Pravastatin Exclusivity tevapharm.com ↗
2002-05-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Tentative FDA Approval for Pravastatin Tablets tevapharm.com ↗

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 166 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 ↗ 161 “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 ↗ “All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin” NCT01634906 ↗ “Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)” NCT01972178 ↗ “or any other cholesterol-lowering drugs such as pravastatin 80 mg daily” NCT00127218 ↗ “Patient has 10mg oral administration of Pravastatin per day.” NCT00361530 ↗ “Patient has 10mg oral administration of Pravastatin per day.” NCT00361699 ↗ “Pravastatin 20mg PO q24h” NCT05565976 ↗ “Pravastatin 40 mg” NCT01715714 ↗ “Pravastatin” NCT01563731 ↗ “pravastatin” NCT01890967 ↗ NCT05852769 ↗ NCT01301066 ↗ NCT00006412 ↗ NCT01075555 ↗ NCT00549926 ↗ NCT00654537 ↗ NCT06494111 ↗ NCT01497483 ↗ NCT01857921 ↗ NCT00738972 ↗ NCT02456844 ↗ NCT01254461 ↗ NCT01845194 ↗ NCT00701285 ↗ NCT00382460 ↗ NCT01325818 ↗ NCT00384618 ↗ NCT01342887 ↗ NCT00843661 ↗ NCT01502904 ↗ NCT01256476 ↗ NCT00132717 ↗ NCT00879034 ↗ NCT01857843 ↗ NCT00456365 ↗ NCT02754739 ↗ NCT00211705 ↗ NCT01903694 ↗ NCT01845428 ↗ NCT00005117 ↗ NCT00107523 ↗ NCT02155530 ↗ NCT00631189 ↗ NCT00000539 ↗ NCT00000941 ↗ NCT00433498 ↗ NCT00221754 ↗ NCT01872845 ↗ NCT00738296 ↗ NCT00916747 ↗ NCT03801733 ↗ NCT01557075 ↗ NCT00402376 ↗ NCT00227500 ↗ NCT01268202 ↗ NCT02484261 ↗ NCT02305355 ↗ NCT03510715 ↗ NCT04425902 ↗ NCT01004237 ↗ NCT00467831 ↗ NCT02360826 ↗ NCT03073018 ↗ NCT02871687 ↗ NCT00599625 ↗ NCT02992548 ↗ NCT06324396 ↗ NCT00330980 ↗ NCT00529178 ↗ NCT00652327 ↗ NCT07098975 ↗ NCT00702130 ↗ NCT00017758 ↗ NCT02547402 ↗ NCT00214604 ↗ NCT00177580 ↗ NCT00731016 ↗ NCT00794963 ↗ NCT02229773 ↗ NCT01717586 ↗ NCT00755352 ↗ NCT06785727 ↗ NCT00305201 ↗ NCT00405717 ↗ NCT00000542 ↗ NCT01173939 ↗ NCT01057654 ↗ NCT01038154 ↗ NCT03944512 ↗ NCT00380939 ↗ NCT07217938 ↗ NCT04608344 ↗ NCT01357486 ↗ NCT04190433 ↗ NCT04719481 ↗ NCT00039663 ↗ NCT03273413 ↗ NCT00303277 ↗ NCT01788254 ↗ NCT04356209 ↗ NCT00464503 ↗ NCT03882177 ↗ NCT00639223 ↗ NCT02431013 ↗ NCT03131973 ↗ NCT00459745 ↗ NCT02079974 ↗ NCT00840177 ↗ NCT07704918 ↗ NCT01082588 ↗ NCT00982189 ↗ NCT03219372 ↗ NCT00830258 ↗ NCT01515813 ↗ NCT00697203 ↗ NCT01816997 ↗ NCT00117494 ↗ NCT06856772 ↗ NCT06357104 ↗ NCT00834379 ↗ NCT00571194 ↗ NCT01934569 ↗ NCT00166036 ↗ NCT00665717 ↗ NCT03456102 ↗ NCT01958489 ↗ NCT00221104 ↗ NCT03127631 ↗ NCT02266485 ↗ NCT04640571 ↗ NCT00257686 ↗ NCT01418729 ↗ NCT01856374 ↗ NCT00054938 ↗ NCT00000461 ↗ NCT00834847 ↗ NCT03648970 ↗ NCT00829309 ↗ NCT00688896 ↗ NCT00005010 ↗ NCT00630734 ↗ NCT04284657 ↗ NCT00688922 ↗ NCT05251129 ↗ NCT00362206 ↗ NCT00200655 ↗ NCT03510884 ↗ NCT02841774 ↗ NCT02166593 ↗ NCT05524246 ↗ NCT02621957 ↗ NCT01441908 ↗
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 ↗ 3 “40 mg Pravastatin (Pravachol)” NCT00330980 ↗ “Pravachol” NCT00532311 ↗ “Pravachol” NCT01293097 ↗
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 ↗ 2 “Drug: Pravastatin Sodium 80 MG” NCT04719481 ↗ NCT01831232 ↗
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 ↗