CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

lovastatin

Trade name: mevacor

Small moleculeapproved

Approved

Aug 31, 1987

Lovastatin acid is an active metabolite of hypolipidemic drug Lovastatin. Lovastatin acid inhibits HMG-CoA reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin has been shown to reduce both normal and elevated low-density lipoprotein cholesterol (LDL-C). Lovastatin in approved for prevention of cardiovascular events and hypercholesterolemia. Off-label use of lovastatin includes treatmetn of diabetic dyslipidemia, familial dysbetalipoproteinemia, familial combined hyperlipidemia, or nephrotic hyperlipidemia. Lovastatin was tested in clinical trials agains radioation injury during therapy of prostate cancer. — NCATS

Clinical trial activity

57 trials · 70 clinical orgs · 17 marketing orgs

Phase 1
11
Phase 2
38
Phase 3
11
Phase 4
6

Earliest trial started Jan 1, 1984 (NCT00000512)

Timeline

1980s

  1. Jan 1, 1984

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1985

    Merck — Earliest Phase 2 Sponsor(trial)

  3. Aug 31, 1987

    Merck — Earliest FDA Approval

  4. Aug 31, 1987

    Merck — NDA Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Dec 17, 2001

    Epic Pharma Llc — Marketing Organization

  3. Dec 17, 2001

    Actavis — Marketing Organization

  4. Dec 17, 2001

    Beximco — Marketing Organization

  5. Dec 17, 2001

    Mylan — Marketing Organization

  6. Dec 17, 2001

    Sandoz — Marketing Organization

  7. Dec 17, 2001

    Teva — Marketing Organization

  8. Dec 17, 2001

    Chartwell Pharmaceuticals — Marketing Organization

  9. Dec 17, 2001

    Aurobindo Pharma — Marketing Organization

  10. Jun 5, 2002

    Ionis Pharmaceuticals, Inc. — Marketing Organization

  11. Jun 26, 2002

    Covis — NDA Secondary Org

  12. Jun 26, 2002

    Covis — Marketing Organization

  13. Jun 26, 2002

    Azurity — Marketing Organization

  14. Apr 14, 2006

    Sun Pharmaceuticals — Marketing Organization

  15. Feb 28, 2007

    Apotex — Marketing Organization

  16. Feb 28, 2007

    Corepharma — Marketing Organization

  17. Feb 28, 2007

    Impax Laboratories — Marketing Organization

  18. Nov 1, 2007

    Lupin — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 31, 1987

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H](C)C(=O)O[C@H]1C[C@@H](C)C=C2C=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(O)=O)[C@@H]12
Mol. weight
422.5549 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

First in classProdrug

Sources

Also known as

  • (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(2r,4r)-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl (s)-2-methyl-butyrate
  • (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(2r,4r)-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl (s)-2-methyl-butyrate
  • 2beta,6alpha-dimethyl-8alpha-(2-methyl-1-oxobutoxy)-mevinic acid lactone
  • 2beta,6alpha-dimethyl-8alpha-(2-methyl-1-oxobutoxy)-mevinic acid lactone
  • 6-alpha-methylcompactin
  • 6-alpha-methylcompactin
  • 6alpha-methylcompactin
  • 6alpha-methylcompactin
  • 6α-methylcompactin
  • 6α-methylcompactin
  • altoprev
  • altoprev
  • lostatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatin
  • lovastatina
  • lovastatina
  • lovastatine
  • lovastatine
  • lovastatinum
  • lovastatinum
  • mevacor
  • mevacor
  • mevacor
  • mevacor
  • mevacor
  • mevinacor
  • mevinacor
  • mevinacor 10
  • mevinacor 40
  • mevinolin
  • mevinolin
  • mevinolin
  • mk0803
  • mk-803
  • mk-803
  • ml-530b
  • ml-530b

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07282756N/AJul 11, 2025Silesian University of Medicine
NCT06636734Phase 2Oct 21, 2024Emory University, National Cancer Institute (NCI)
NCT04297033Phase 2Jan 1, 2021Capital Medical University
NCT04359823Phase 1/Phase 2 (Phase 2)Jul 1, 2020Medical University of South Carolina
NCT06789497N/AJan 12, 2020University of Coimbra
NCT03826940N/AFeb 19, 2019University of Coimbra
NCT03504501Phase 2Oct 31, 2018Technical University of Munich
NCT03510715Phase 3Sep 3, 2018Regeneron, Sanofi
NCT03510884Phase 3May 31, 2018Regeneron, Sanofi
NCT03981601Phase 2Feb 22, 2018Azad University
NCT03242499Phase 2May 15, 2017National Taiwan University
NCT03470376Phase 4Jan 15, 2017University of Perugia
NCT02964884Phase 2Nov 1, 2016National Institutes of Health (NIH), Vanderbilt University
NCT02680379Phase 2Mar 1, 2016Centre de Recherche Clinique du CHUS, FRAXA Research Foundation, University of Sherbrooke
NCT02642653Phase 4Jan 1, 2016University of California, Davis
NCT02998151Phase 2Jan 1, 2016National Institutes of Health (NIH), University of Cincinnati
NCT03178526Phase 2/Phase 3 (Phase 3)Dec 24, 2015Azad University
NCT02603770Phase 1Nov 1, 2015Luye Pharma
NCT02563860Phase 2Jul 1, 2015Rett Syndrome Research Trust, Yeshiva University
NCT02389868Phase 2Feb 1, 2015University of Sherbrooke
Showing 20 of 57 trials
Page 1 / 3

Organizations

Research & Development (70)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government5321984
Kos PharmaceuticalsFor profit3222003
MerckFor profit3311985
National Cancer Institute (NCI)Government3112007
National Institutes of Health (NIH)Government3022010
University of IowaAcademic/Hospital3312001
Azad UniversityAcademic/Hospital2222015
Columbia UniversityAcademic/Hospital2222005
Mutual PharmaceuticalFor profit2212004
National Taiwan UniversityAcademic/Hospital2222012
RegeneronFor profit2012018
SanofiFor profit2212018
University of ChicagoAcademic/Hospital2112008
University of CincinnatiAcademic/Hospital2112009
University of CoimbraAcademic/Hospital2212019
University of SherbrookeAcademic/Hospital2212015
University of WashingtonAcademic/Hospital2121984
Virginia Commonwealth UniversityAcademic/Hospital2212007
Wake Forest UniversityAcademic/Hospital2011988
Washington University in St. LouisAcademic/Hospital2122007
70 organizations
Page 1 / 4

Marketing (19)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGDec 17, 2001
ApotexFor profitMKTGFeb 28, 2007
Aurobindo PharmaFor profitMKTGDec 17, 2001
AzurityFor profitMKTGJun 26, 2002
BeximcoFor profitMKTGDec 17, 2001
Chartwell PharmaceuticalsFor profitMKTGDec 17, 2001
CorepharmaFor profitMKTGFeb 28, 2007
CovisFor profitNDA2Jun 26, 2002
CovisFor profitMKTGJun 26, 2002
Epic Pharma LlcFor profitMKTGDec 17, 2001
Epic Pharma LlcFor profitSYNDec 17, 2001
Impax LaboratoriesFor profitMKTGFeb 28, 2007
Ionis Pharmaceuticals, Inc.For profitMKTGJun 5, 2002
LupinFor profitMKTGNov 1, 2007
MerckFor profitNDAAug 31, 1987
MylanFor profitMKTGDec 17, 2001
SandozFor profitMKTGDec 17, 2001
Sun PharmaceuticalsFor profitMKTGApr 14, 2006
TevaFor profitMKTGDec 17, 2001