Fluvastatin

also known as Lescol · fluvastatin (Lescol) · fluvastatin XL

Developed for: hyperlipidemia · atherosclerosis · hyperlipidemia, combined, 2 · hypertensive disorder · chronic hepatitis C virus infection · coronary artery disorder · metabolic syndrome X · myocardial infarction
+19 more
· transient ischemic attack · Alport syndrome · antiphospholipid syndrome · aortic valve stenosis · breast cancer · familial hypercholesterolemia · hepatitis C virus infection · hyperlipoproteinemia · inherited lipid metabolism disorder · melanoma · platinum-induced ototoxicity · prostate cancer · schizophrenia · statin toxicity · type 2 diabetes mellitus · vasculogenic impotence · chronic kidney disease · disease related to transplantation · proteinuria
Investigated by: Novartis · Bader, Ted, M.D. · Novartis Pharmaceuticals · US Department of Veterans Affairs · University Hospital Schleswig-Holstein · University Medical Centre Ljubljana
+31 more
· University of California, San Francisco · Beijing Anzhen Hospital · Case Comprehensive Cancer Center · Chinese Hypertension League · Corcept Therapeutics · European Society of Hypertension · Hospital for Special Surgery, New York · Istituto Auxologico Italiano · Kitasato University · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Mario Negri Institute for Pharmacological Research · Minia University · Minia University Hospital · Ministry of Health, Czech Republic · National Cancer Institute (NCI) · Organon and Co · Prof. dr. Nathalie van der Velde · Sint Franciscus Gasthuis · St. Marianna University School of Medicine · Tokai University · University Health Network, Toronto · University Hospital, Saarland · University of Basel · University of Bologna · University of Chicago · University of Leipzig · University of Maryland, Baltimore · University of Texas · University of Zurich · VU University of Amsterdam · Yokohama City University Medical Center

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (2)	US (FDA)	LESCOL XL	—	2003-05-27 – 2006-04-10	fda.gov ↗
Label expansions (5)	US (FDA)	LESCOL	—	1996-03-20 – 2000-12-18	fda.gov ↗
Approved	US (FDA)	LESCOL	—	1993-12-31	fda.gov ↗

Trials 39

today

US approved 1993

NCT06785727 · Ph 4 NCT06553157 · Ph 1/2 NCT04285749 · Ph 0 NCT04029584 · Ph 4 NCT03189511 · Ph 4 NCT03393377 · not/applicable NCT01992042 · Ph 2 NCT01563731 · Ph 4 NCT03309618 · not/applicable NCT01681199 · Ph 4 NCT01634906 · not/applicable NCT01514682 · not/applicable NCT01551173 · Ph 4 NCT01259791 · not/applicable NCT00814606 · Ph 2 NCT00752843 · Ph 1 NCT00674297 · Ph 2 NCT00487318 · Ph 2 NCT00489424 · Ph 4 NCT00382161 · Ph 3 NCT00407680 · Ph 4 NCT00441493 · not/applicable NCT00664742 · Ph 4 NCT00385658 · Ph 4 NCT00416403 · Ph 2 NCT00821574 · Ph 4 NCT00136799 · Ph 3 NCT00125125 · Ph 4 NCT00223028 · Ph 4 NCT00132717 · Ph 3 NCT00421005 · Ph 4 NCT00138528 · Ph 4 NCT00171262 · Ph 4 NCT00171327 · Ph 4 NCT00223015 · Ph 4 NCT00309257 · Ph 2 NCT00171275 · Ph 4 NCT00176410 · Ph 2 NCT00171236 · Ph 3

1993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT04285749	Nov 2020 → Apr 2021	melanoma	Case Comprehensive Cancer Center	Withdrawn	No outcome recorded
Phase 11 trial
Phase 1	NCT00752843	Sep → Nov 2008	—	Corcept Therapeutics	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT06553157	Sep 2024 → Jul 2025	cancer, platinum-induced ototoxicity	Minia University	Completed	No outcome recorded
Phase 27 trials
Phase 2	NCT01992042	Feb 2014 → Oct 2016	prostate cancer	University Health Network, Toronto	Completed	No outcome recorded
Phase 2	NCT00814606	Feb → Oct 2010	hepatitis C virus infection	University of Chicago	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT00674297	May 2008 → Jul 2011	antiphospholipid syndrome	Hospital for Special Surgery, New York	Completed	No outcome recorded
Phase 2	NCT00487318	Jun 2007 → Oct 2010	chronic hepatitis C virus infection	Bader, Ted, M.D.	Completed	No outcome recorded
Phase 2	NCT00416403	Jul 2006 → Sep 2007	breast cancer	University of California, San Francisco	Completed	No outcome recorded
Phase 2	NCT00309257	Jan 2004 → Jun 2008	Alport syndrome	Mario Negri Institute for Pharmacological Research	Completed	No outcome recorded
Phase 2	NCT00176410	Jan 2003 → Sep 2009	aortic valve stenosis	University of Leipzig	Unknown	No outcome recorded
Phase 34 trials
Phase 3	NCT00382161	Oct 2006 → Dec 2007	vasculogenic impotence	University Hospital, Saarland	Withdrawn	No outcome recorded
Phase 3	NCT00136799	Jun 2005 → Apr 2006	hyperlipidemia, combined, 2, hyperlipoproteinemia	Novartis	Completed	No outcome recorded
Phase 3	NCT00132717	Jan 2005 → Jun 2007	hyperlipidemia	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00171236	Oct 2001 → Mar 2005	familial hypercholesterolemia, hyperlipidemia, combined, 2	Novartis	Completed	No outcome recorded
Phase 419 trials · 1 missed
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	NCT04029584	Apr 2019 → Apr 2020	—	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT03189511	May 2017 → Jan 2018	—	University of Zurich	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	NCT01681199	Jul 2012 → Apr 2014	atherosclerosis, coronary artery disorder	Beijing Anzhen Hospital	Unknown	No outcome recorded
Phase 4	NCT01551173	Jan 2012 → May 2013	inherited lipid metabolism disorder	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT00489424	Jun → Dec 2007	osteoporosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT00407680	Oct 2006 → Mar 2009	hypertensive disorder, type 2 diabetes mellitus	Kitasato University	Unknown	No outcome recorded
Phase 4	NCT00664742	Sep 2006 → Oct 2007	metabolic syndrome X	Novartis	Completed	No outcome recorded
Phase 4	NCT00385658	Aug 2006 → Mar 2007	hyperlipidemia	Novartis	Completed	No outcome recorded
Phase 4	NCT00821574	Jul 2005 → Mar 2007	hyperlipidemia, combined, 2	Novartis	Completed	No outcome recorded
Phase 4	NCT00125125	May → Dec 2005	hyperlipidemia	Novartis	Completed	No outcome recorded
Phase 4	NCT00223028	Apr → Jul 2005	—	University Hospital Schleswig-Holstein	Completed	No outcome recorded
Phase 4	NCT00421005	Nov 2004 → Nov 2008	hyperlipidemia	University of Bologna	Unknown	No outcome recorded
Phase 4	NCT00138528	Oct 2004 → Feb 2006	metabolic syndrome X	Novartis	Completed	No outcome recorded
Phase 4	NCT00171262	Aug 2004 → Jun 2007	hyperlipidemia	Novartis	Completed	No outcome recorded
Phase 4	NCT00171327	Jul 2004 → Sep 2005	hyperlipidemia, hypertensive disorder	Novartis	Completed	No outcome recorded
Phase 4	NCT00223015	May 2004 → Apr 2005	—	University Hospital Schleswig-Holstein	Completed	No outcome recorded
Phase 4	NCT00171275	Nov 2003 → Feb 2007	coronary artery disorder, myocardial infarction	Novartis	Completed	Missed primary

Phase not applicable6 trials · 1 missed
—	NCT03393377	Sep 2014 → Jun 2015	atherosclerosis	University Medical Centre Ljubljana	Completed	No outcome recorded
—	NCT03309618	Nov 2012 → Nov 2013	myocardial infarction	University Medical Centre Ljubljana	Completed	No outcome recorded
—	NCT01634906	Jul 2012 → Mar 2013	atherosclerosis, hyperlipidemia	Sint Franciscus Gasthuis	Completed	No outcome recorded
—	NCT01514682	Jun 2012 → Apr 2017	schizophrenia	University of Maryland, Baltimore	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
—	NCT00441493	Sep 2006 → Mar 2007	chronic hepatitis C virus infection	Bader, Ted, M.D.	Completed	No outcome recorded
Comparator or background therapy17 trials
Phase 2	NCT01890967 Background	Jun 2013 → Apr 2014	hyperlipoproteinemia	Eli Lilly and Company	Completed	No outcome recorded
Phase 2	NCT01045512 Comparator	Oct 2009 → Sep 2014	—	Martin-Luther-University Halle-Wittenberg	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT00223041 Comparator	Apr 2003 → Nov 2009	—	University Hospital Schleswig-Holstein	Terminated	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	NCT00532311 Comparator	Jul 2007 → Apr 2008	hyperlipidemia	Takeda	Terminated	No outcome recorded
Phase 3	NCT00127218 Background	Sep 2003 → Dec 2008	atherosclerosis	Johns Hopkins University	Completed	No outcome recorded
Phase 3	NCT00171288 Background	Aug 2003 → Aug 2005	hyperlipidemia	Novartis	Completed	No outcome recorded
Phase 3	NCT00199927 Comparator	Mar 2003 → Dec 2007	chronic kidney disease, hypertensive disorder, proteinuria	Mario Negri Institute for Pharmacological Research	Completed	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	NCT01293097 Background	Jun 2010 → Oct 2011	acute coronary syndrome, myocardial infarction	Peking University First Hospital	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	NCT00404287 Comparator	Oct 2006 → Nov 2014	aortic valve stenosis	AORTICA Group	Terminated	No outcome recorded Stop: Business
Phase 4	NCT00814723 Comparator	Sep 2005 → Sep 2007	hyperlipoproteinemia	Medical University of Graz	Completed	No outcome recorded
Phase 4	NCT00565474 Comparator	Sep 2001 → Oct 2007	disease related to transplantation	Novartis Pharmaceuticals	Completed	No outcome recorded

Press releases naming this drug 1 release

Date	Issuer	Release
2021-07-12	Lannett Company, Inc.	Lannett Launches Fluvastatin Sodium ER Tablets investorroom.com ↗

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 57 sources stand behind the page.

Field	Value	Cited text
Known as	Fluvastatin	“One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824 ↗ 53 “3. Fluvastatin, 40 mgs/day. Fluvastatin is a lipid-lowering drugs, which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA).” NCT01514682 ↗ “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 ↗ “Statins include atorvastatin , fluvastatin , lovastatin , pitavastatin , pravastatin, rosuvastatin and simvastatin.” NCT06553157 ↗ “Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis” NCT00127218 ↗ “All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin” NCT01634906 ↗ “Fluvastatin 80 mg” NCT01715714 ↗ “Fluvastatin” NCT01563731 ↗ “fluvastatin” NCT01890967 ↗ NCT00223015 ↗ Show 43 more sources
Known as	fluvastatin (Lescol)	“fluvastatin (Lescol)” NCT00127218 ↗
Known as	fluvastatin XL	“This study was designed to assess the efficacy and tolerability of extended-release fluvastatin (fluvastatin XL) and ezetimibe alone or in combination in patients with previous...” PMID 18312764 ↗ Dec 2007
Known as	Lescol	“one oral dose of fluvastatin (Lescol®) 20mg capsule” NCT04029584 ↗ 2 “Lescol” NCT00532311 ↗ “Lescol” NCT01293097 ↗
Action	Inhibit	“statins (HMG CoA reductase inhibitors)” NCT00176410 ↗
Modality	Other / unclassified	“Fluvastatin is a lipid-lowering drugs” NCT01514682 ↗
Route	Oral	“Given orally” NCT00416403 ↗