fluvastatin

Trade name: lescol

Small moleculeapproved

Approved

Dec 31, 1993

Fluvastatin is an antilipemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin is marketed under the trade names Lescol, Canef, Vastin. LESCOL/LESCOL XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD Slow the progression of atherosclerosis in patients with CHD. Fluvastatin selectively and competitively inhibits the hepatic enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase is responsible for converting HMG-CoA to mevalonate, the rate-limiting step in cholesterol biosynthesis. Inhibition results in a decrease in hepatic cholesterol levels which stimulates the synthesis of LDL receptors and increases hepatic uptake of LDL cholesterol. The end result is decreased levels of plasma total and LDL cholesterol. — NCATS

Clinical trial activity

51 trials · 42 clinical orgs · 7 marketing orgs

Phase 1
4
Phase 2
21
Phase 3
13
Phase 4
22

Earliest trial started Sep 1, 2001 (NCT00565474)

Timeline

1990s

  1. Dec 31, 1993

    Earliest FDA Approval

  2. Dec 31, 1993

    Novartis — NDA Secondary Org

2000s

  1. Oct 6, 2000

    Sandoz — Marketing Organization

  2. Jan 1, 2001

    Novartis — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  5. Sep 15, 2009

    Par Pharmaceuticals — Marketing Organization

2010s

  1. Apr 11, 2012

    Mylan — Marketing Organization

  2. Jun 12, 2012

    Teva — Marketing Organization

  3. Sep 11, 2015

    PHARMOBEDIENT — Marketing Organization

2020s

  1. Apr 26, 2021

    Beijing Pearl Biotechnology Limited Liability Company — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedDec 31, 1993

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)n1c(/C=C/C(O)CC(O)CC(=O)O)c(-c2ccc(F)cc2)c2ccccc21
Mol. weight
411.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (3s,5s)-fluvastatin
  • 7-(3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl)-3,5-dihydroxy-6-heptenoate
  • dorisin xl
  • fluindostatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatin
  • fluvastatina
  • fluvastatina
  • fluvastatine
  • fluvastatine
  • fluvastatin sodium
  • fluvastatin sodium
  • fluvastatin sodium
  • fluvastatin sodium
  • fluvastatin sodium
  • fluvastatin sodium hydrate
  • fluvastatin sodium salt
  • fluvastatin sodium salt
  • fluvastatinum
  • fluvastatinum
  • leschol
  • lescol
  • lescol
  • lescol
  • lescol
  • lescol
  • lescol
  • lescol
  • luvinsta xl
  • nandovar xl
  • pinmactil
  • stefluvin xl
  • xu 62320
  • xu 62-320
  • xu-62320
  • xu-62320
  • xu-62320
  • xu-62-320

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06785727Phase 4Feb 1, 2025University of Amsterdam
NCT06679036Phase 1/Phase 2 (Phase 2)Nov 25, 2024Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT04285749Early Phase 1 (Phase 1)May 6, 2020Case Western Reserve University
NCT03510715Phase 3Sep 3, 2018Regeneron, Sanofi
NCT03510884Phase 3May 31, 2018Regeneron, Sanofi
NCT03189511Phase 4May 31, 2017University of Basel, University of Zurich
NCT03393377N/ASep 30, 2014University of Ljubljana
NCT02115074Phase 1Jun 1, 2014Reliable Cancer Therapies, University of Lille
NCT02107898Phase 3Mar 1, 2014Regeneron, Sanofi
NCT01992042Phase 2Feb 1, 2014University of Toronto
NCT03309618N/ANov 30, 2012University of Ljubljana
NCT01715714Phase 4Oct 1, 2012German Federal Ministry of Education and Research, University of Cologne
NCT01681199Phase 4Jul 1, 2012Capital Medical University, Novartis
NCT01644175Phase 3Jul 1, 2012Regeneron, Sanofi
NCT01514682N/AJun 1, 2012University of Maryland
NCT01507831Phase 3Jan 1, 2012Regeneron, Sanofi
NCT01551173Phase 4Jan 1, 2012Novartis
NCT00814606Phase 2Feb 1, 2010University of Chicago
NCT01045512Phase 2Oct 1, 2009Martin Luther University, Novartis
NCT00752843Phase 1Sep 1, 2008Corcept Therapeutics, MDS Pharma
Showing 20 of 51 trials
Page 1 / 3

Organizations

Research & Development (42)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit181432001
RegeneronFor profit5012012
SanofiFor profit5512012
Universitaetsklinikum Schleswig-HolsteinAcademic/Hospital3322003
Department of Veteran AffairsGovernment2222006
Mario Negri InstituteAcademic/Hospital2222003
University of LjubljanaAcademic/Hospital2212012
University of OklahomaAcademic/Hospital2022006
Yokohama City UniversityAcademic/Hospital2112006
AORTICA GroupFor profit1112006
Capital Medical UniversityAcademic/Hospital1112012
Case Western Reserve UniversityAcademic/Hospital1112020
Corcept TherapeuticsFor profit1112008
German Federal Ministry of Education and ResearchGovernment1012012
Government of Czech RepublicGovernment1012003
Kitasato UniversityAcademic/Hospital1112006
Martin Luther UniversityAcademic/Hospital1112009
MDS PharmaFor profit1012008
Medical University of GrazAcademic/Hospital1112005
MerckFor profit1112005
42 organizations
Page 1 / 3

Marketing (10)

OrganizationOrg typeRelationshipDate
Beijing Pearl Biotechnology Limited Liability CompanyGovernmentMKTGApr 26, 2021
MylanFor profitMKTGApr 11, 2012
MylanFor profitSYNSep 11, 2015
NovartisFor profitNDA2Dec 31, 1993
PHARMOBEDIENTFor profitMKTGSep 11, 2015
Par PharmaceuticalsFor profitMKTGSep 15, 2009
SandozFor profitNDA
SandozFor profitMKTGOct 6, 2000
TevaFor profitMKTGJun 12, 2012
TevaFor profitSYNJan 27, 2016