pravastatin

Trade name: pravachol

Small moleculeapproved

Approved

Oct 31, 1991

Pravastatin (marketed as Pravachol or Selektine) is a member of the drug class of statins, used in combination with diet, exercise, and weight loss for lowering cholesterol and preventing cardiovascular disease. Pravastatin acts as a lipoprotein-lowering drug through two pathways. In the major pathway, pravastatin inhibits the function of hydroxymethylglutaryl-CoA (HMG-CoA) reductase. As a reversible competitive inhibitor, pravastatin sterically hinders the action of HMG-CoA reductase by occupying the active site of the enzyme. Taking place primarily in the liver, this enzyme is responsible for the conversion of HMG-CoA to mevalonate in the rate-limiting step of the biosynthetic pathway for cholesterol. Pravastatin also inhibits the synthesis of very-low-density lipoproteins, which are the precursor to low-density lipoproteins (LDL). These reductions increase the number of cellular LDL receptors, thus LDL uptake increases, removing it from the bloodstream. Pravastatin is primarily used for the treatment of dyslipidemia and the prevention of cardiovascular disease. It is recommended to be used only after other measures, such as diet, exercise, and weight reduction, have not improved cholesterol levels. The evidence for the use of pravastatin is generally weaker than for other statins. The antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT), failed to demonstrate a difference in all-cause mortality or nonfatal myocardial infarction/fatal coronary heart disease rates between patients receiving pravastatin 40 mg daily (a common starting dose) and those receiving usual care. Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of Pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant. — NCATS

Clinical trial activity

157 trials · 166 clinical orgs · 24 marketing orgs

Phase 1
43
Phase 2
60
Phase 3
29
Phase 4
42

Earliest trial started Dec 1, 1986 (NCT00000461)

Timeline

1980s

  1. Jan 1, 1986

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Oct 31, 1991

    Bristol-Myers Squibb — Earliest FDA Approval

  2. Oct 31, 1991

    Bristol-Myers Squibb — NDA Organization

  3. Jan 1, 1992

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Sep 30, 2003

    Ranbaxy — Marketing Organization

  2. Apr 24, 2006

    Teva — Marketing Organization

  3. Oct 23, 2006

    Apotex — Marketing Organization

  4. Oct 23, 2006

    Apnar Pharma — Marketing Organization

  5. Oct 23, 2006

    Cipla — Marketing Organization

  6. Oct 23, 2006

    Dr. Reddy's Laboratories — Marketing Organization

  7. Oct 23, 2006

    Mylan — Marketing Organization

  8. Oct 23, 2006

    Sandoz — Marketing Organization

  9. Oct 23, 2006

    Watson Pharmaceuticals — Marketing Organization

  10. Oct 23, 2006

    Novartis — Marketing Organization

  11. Oct 23, 2006

    PHARMOBEDIENT — Marketing Organization

  12. Nov 21, 2006

    Pliva — Marketing Organization

  13. Nov 21, 2006

    Barr Laboratories — Marketing Organization

  14. May 11, 2007

    Glenmark Pharmaceuticals — Marketing Organization

  15. Jan 8, 2008

    Lupin — Marketing Organization

  16. Feb 11, 2008

    Senores Pharms — Marketing Organization

  17. Apr 30, 2008

    Zydus Discovery DMCC — Marketing Organization

2010s

  1. Nov 17, 2016

    Accord Research — Marketing Organization

  2. Feb 2, 2017

    Aurobindo Pharma — Marketing Organization

  3. Apr 13, 2018

    Chartwell Pharmaceuticals — Marketing Organization

  4. Apr 13, 2018

    Appco Pharma — Marketing Organization

  5. Apr 13, 2018

    Biocon Limited — Marketing Organization

  6. Nov 23, 2018

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedOct 31, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H](C)C(=O)O[C@H]1C[C@H](O)C=C2C=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(=O)O)[C@H]21
Mol. weight
424.53 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (+)-(3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(s)-2-methylbutyryl]oxy}-1,2,6,7,8,8a-hexahydro-1-naphthyl]heptanoic acid
  • (+)-(3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(s)-2-methylbutyryl]oxy}-1,2,6,7,8,8a-hexahydro-1-naphthyl]heptanoic acid
  • cs-514
  • cs-514
  • dehypotin
  • elisor
  • elisor
  • eptastatin
  • eptastatin sodium
  • eptastatin sodium
  • fenofibrate / pravastatin
  • hgp0816
  • lipemol
  • lipemol
  • liplat
  • liplat
  • lipostat
  • lipostat
  • mevalothin
  • pravachol
  • pravachol
  • pravachol
  • pravachol
  • pravachol
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatin
  • pravastatina
  • pravastatina
  • pravastatin acid
  • pravastatin acid
  • pravastatin acid
  • pravastatine
  • pravastatine
  • pravastatin sodium
  • pravastatin sodium
  • pravastatin sodium
  • pravastatin sodium
  • pravastatinum
  • pravastatinum
  • sq-31000
  • sq-31000

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07217938Phase 2Dec 1, 2025Peter MacCallum Cancer Centre
NCT07098975Phase 2Sep 30, 2025Universidad Autonoma de Barcelona, University of Barcelona
NCT06912763Phase 2Aug 8, 2025University of Texas at Houston
NCT06856772Phase 4Feb 28, 2025University of Copenhagen
NCT06785727Phase 4Feb 1, 2025University of Amsterdam
NCT06494111Phase 2Nov 29, 2024University of Texas at Houston
NCT06324396Phase 1Mar 1, 2024Indiana University, University of Kansas
NCT05852769Phase 1May 31, 2023Bristol-Myers Squibb
NCT05524246Phase 1Nov 30, 2022University of Cincinnati
NCT04719481Phase 4Nov 30, 2021Peking University
NCT04608344Phase 1Nov 4, 2020Galapagos NV, Gilead Sciences
NCT04356209Phase 2Jun 30, 2020University of Montpellier
NCT04425902Phase 1Jun 16, 2020ViiV Healthcare
NCT04190433Phase 2Jan 1, 2020Mayo Clinic
NCT04092751Phase 1Oct 22, 2019Clinical Network Services, Scynexis, Inc.
NCT03944512Phase 3Jun 30, 2019George Washington University, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Texas, Galveston
NCT03882177Phase 2Jun 15, 2019Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID), University of the Witwatersrand
NCT03456102Phase 2Feb 1, 2019Johns Hopkins University
NCT04284657Phase 2Jan 30, 2019University of Southern California
NCT03510715Phase 3Sep 3, 2018Regeneron, Sanofi
Showing 20 of 157 trials
Page 1 / 8

Organizations

Research & Development (166)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Yonsei UniversityAcademic/Hospital8732009
National Heart, Lung, and Blood Institute (NHLBI)Government7331986
Bristol-Myers SquibbFor profit6432000
Harvard UniversityAcademic/Hospital6531986
MerckFor profit6232005
National Institute of Allergy and Infectious Diseases (NIAID)Government6531999
Hanmi PharmaceuticalFor profit5522014
RegeneronFor profit5012012
SanofiFor profit5512012
AstraZenecaFor profit4432001
National Cancer Institute (NCI)Government4022009
TevaFor profit4412000
University of WashingtonAcademic/Hospital4442002
Daiichi SankyoFor profit3111994
KowaFor profit3322005
National Institutes of Health (NIH)Government3132002
Pharma MedicaFor profit3012000
University of Colorado, DenverAcademic/Hospital3322006
AAIPharmaFor profit2012002
American Heart AssociationAcademic/Hospital2022009
166 organizations
Page 1 / 9

Marketing (30)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGNov 17, 2016
Apnar PharmaFor profitMKTGOct 23, 2006
ApotexFor profitSYNOct 23, 2006
ApotexFor profitMKTGOct 23, 2006
Appco PharmaFor profitMKTGApr 13, 2018
Aurobindo PharmaFor profitMKTGFeb 2, 2017
Aurobindo PharmaFor profitSYNFeb 2, 2017
Aurobindo PharmaFor profitSYNApr 24, 2006
Barr LaboratoriesFor profitMKTGNov 21, 2006
Biocon LimitedFor profitMKTGApr 13, 2018
Bristol-Myers SquibbFor profitNDAOct 31, 1991
Chartwell PharmaceuticalsFor profitMKTGApr 13, 2018
CiplaFor profitMKTGOct 23, 2006
Dr. Reddy's LaboratoriesFor profitMKTGOct 23, 2006
Glenmark PharmaceuticalsFor profitMKTGMay 11, 2007
Glenmark PharmaceuticalsFor profitSYNMay 11, 2007
LupinFor profitMKTGJan 8, 2008
MylanFor profitMKTGOct 23, 2006
MylanFor profitSYNMay 27, 2010
NovartisFor profitMKTGOct 23, 2006
PHARMOBEDIENTFor profitMKTGOct 23, 2006
PlivaFor profitMKTGNov 21, 2006
RanbaxyFor profitMKTGSep 30, 2003
SandozFor profitMKTGOct 23, 2006
Senores PharmsFor profitMKTGFeb 11, 2008
TevaFor profitMKTGApr 24, 2006
TevaFor profitSYNJan 15, 2008
Watson PharmaceuticalsFor profitMKTGOct 23, 2006
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGNov 23, 2018
Zydus Discovery DMCCFor profitMKTGApr 30, 2008