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simvastatin

Trade name: zocor

Small moleculeapproved

Approved

Dec 23, 1991

Simvastatin is a HMG-CoA Reductase Inhibitor that is FDA approved for the treatment of hypercholesterolemia and for the reduction in the risk of cardiac heart disease mortality and cardiovascular events. It reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL). Common adverse reactions include abdominal pain, constipation, nausea, headache, upper respiratory infection. Cases of myopathy/rhabdomyolysis have been observed with simvastatin co-administered with lipid-modifying doses ( ≥ 1 g/day niacin) of niacin-containing products. The risk of myopathy, including rhabdomyolysis, is increased by concomitant administration of amiodarone, dronedarone, ranolazine, or calcium channel blockers such as verapamil, diltiazem, or amlodipine. — NCATS

Clinical trial activity

556 trials · 400 clinical orgs · 27 marketing orgs

Phase 1
114
Phase 2
247
Phase 3
164
Phase 4
122

Earliest trial started Jun 1, 1991 (NCT00471549)

Timeline

1990s

  1. Dec 23, 1991

    Merck — Earliest FDA Approval

  2. Dec 23, 1991

    Organon — NDA Secondary Org

  3. Dec 23, 1991

    Merck — NDA Organization

  4. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jul 23, 2004

    Merck — Marketing Organization

  3. Jun 23, 2006

    Teva — Marketing Organization

  4. Jun 23, 2006

    Sun Pharmaceuticals — Marketing Organization

  5. Dec 20, 2006

    Chartwell Pharmaceuticals — Marketing Organization

  6. Dec 20, 2006

    Aurobindo Pharma — Marketing Organization

  7. Dec 20, 2006

    Biocon Limited — Marketing Organization

  8. Dec 20, 2006

    Dr. Reddy's Laboratories — Marketing Organization

  9. Dec 20, 2006

    Zydus Discovery DMCC — Marketing Organization

  10. Dec 20, 2006

    Fosun — Marketing Organization

  11. May 11, 2007

    Lupin — Marketing Organization

  12. Oct 9, 2007

    Byondis — NDA Secondary Org

  13. Feb 26, 2008

    Accord Research — Marketing Organization

2010s

  1. Jun 8, 2010

    Mylan — Marketing Organization

  2. Aug 30, 2010

    Oxford Pharmaceuticals — Marketing Organization

  3. Sep 16, 2011

    Viva Healthcare — Marketing Organization

  4. Sep 16, 2011

    Micro Labs Ltd India — Marketing Organization

  5. Nov 25, 2014

    Hetero Labs Ltd — Marketing Organization

  6. Apr 21, 2016

    Tcg Fluent Pharma — Marketing Organization

  7. Apr 21, 2016

    Tcg Fluent Pharma — NDA Secondary Org

  8. Apr 26, 2017

    Ani Pharmaceuticals — Marketing Organization

  9. Apr 26, 2017

    Watson Pharmaceuticals — Marketing Organization

  10. Apr 26, 2017

    Allergan PLC (2015) — Marketing Organization

  11. Nov 13, 2017

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  12. Nov 13, 2017

    Invagen Pharms — Marketing Organization

  13. Nov 21, 2017

    Amneal Pharmaceuticals — Marketing Organization

  14. Dec 22, 2017

    Alkem Labs Ltd — Marketing Organization

  15. Jun 27, 2019

    Glenmark Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 23, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CCC(C)(C)C(=O)O[C@H]1C[C@@H](C)C=C2C=C[C@H](C)[C@H](CC[C@@H]3C[C@@H](O)CC(=O)O3)[C@@H]12
Mol. weight
418.5662 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

Prodrug

Sources

Also known as

  • 2,2-dimethylbutyric acid, 8-ester with (4r,6r)-6-(2-((1s,2s,6r,8s,8ar)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2h-pyran-2-one
  • 2,2-dimethylbutyric acid, 8-ester with (4r,6r)-6-(2-((1s,2s,6r,8s,8ar)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2h-pyran-2-one
  • fenofibrate / simvastatin
  • lacersa
  • mk0733
  • mk-733
  • mk-733
  • ranzolont
  • simvador
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatin
  • simvastatina
  • simvastatina
  • simvastatine
  • simvastatine
  • simvastatin hydroxy acid
  • simvastatinum
  • simvastatinum
  • simvastol
  • sinvacor
  • synvinolin
  • synvinolin
  • synvinolin
  • zocor
  • zocor
  • zocor
  • zocor
  • zocor heart-pro

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07213557Phase 2Nov 30, 2025Fondazione Giovanni Pascale
NCT07102979N/ASep 1, 2025Chang Gung University
NCT07003815Phase 2Jun 30, 2025Huazhong University of Science and Technology
NCT06948747Phase 1May 6, 2025AstraZeneca
NCT06856772Phase 4Feb 28, 2025University of Copenhagen
NCT06785727Phase 4Feb 1, 2025University of Amsterdam
NCT07031778Early Phase 1 (Phase 1)Jan 7, 2025University of Granada
NCT07194447N/AOct 3, 2024University of Baghdad
NCT06399783Phase 4Oct 1, 2024Assiut University
NCT06523465Phase 4Sep 10, 2024People's Liberation Army of China
NCT06431919N/AAug 31, 2024Indian Council of Medical Research, Postgraduate Institute of Medical Education and Research
NCT06566794N/AAug 20, 2024University of Helsinki
NCT06379958Phase 1Apr 8, 2024Modern Biosciences plc
NCT06273111Early Phase 1 (Phase 1)Apr 1, 2024Stanford University
NCT06338241Phase 4Mar 2, 2024Universidad de Murcia, University of Santiago de Compostela
NCT06178640Phase 1Feb 29, 2024Mahidol University
NCT05771675Early Phase 1 (Phase 1)Jan 31, 2024Cedars-Sinai Medical Center, Department of Defense
NCT06186622Phase 1Jan 2, 2024Eli Lilly
NCT06030622Phase 1/Phase 2 (Phase 2)Dec 1, 2023State University of New York, Brooklyn
NCT05821556Phase 2Jun 12, 2023Fondazione Giovanni Pascale
Showing 20 of 556 trials
Page 1 / 28

Organizations

Research & Development (400)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit936651998
AstraZenecaFor profit161432001
Department of Veteran AffairsGovernment13842005
SanofiFor profit121022008
National Heart, Lung, and Blood Institute (NHLBI)Government11341994
RegeneronFor profit11122012
Eli LillyFor profit101022010
Sungkyunkwan UniversityAcademic/Hospital101032005
Ain Shams UniversityAcademic/Hospital9942014
GlaxoSmithKlineFor profit9822005
Harvard UniversityAcademic/Hospital9742002
PfizerFor profit9831999
University of LondonAcademic/Hospital9822005
University of BarcelonaAcademic/Hospital8632004
AbbottFor profit7522002
Johns Hopkins UniversityAcademic/Hospital7622000
National Cancer Institute (NCI)Government7222006
University of Sao PauloAcademic/Hospital7522005
Mahidol UniversityAcademic/Hospital6642008
Schering-PloughFor profit6022003
400 organizations
Page 1 / 20

Marketing (38)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGFeb 26, 2008
Alkem Labs LtdFor profitMKTGDec 22, 2017
Allergan PLC (2015)For profitMKTGApr 26, 2017
Amneal PharmaceuticalsFor profitMKTGNov 21, 2017
Ani PharmaceuticalsFor profitMKTGApr 26, 2017
Ani PharmaceuticalsFor profitSYNApr 26, 2017
Aurobindo PharmaFor profitMKTGDec 20, 2006
Aurobindo PharmaFor profitSYNDec 17, 2020
Biocon LimitedFor profitMKTGDec 20, 2006
Biocon LimitedFor profitSYNDec 20, 2006
ByondisFor profitNDA2Oct 9, 2007
Chartwell PharmaceuticalsFor profitMKTGDec 20, 2006
Dr. Reddy's LaboratoriesFor profitMKTGDec 20, 2006
Dr. Reddy's LaboratoriesFor profitSYNApr 26, 2017
FosunFor profitMKTGDec 20, 2006
Glenmark PharmaceuticalsFor profitMKTGJun 27, 2019
Hetero Labs LtdFor profitMKTGNov 25, 2014
Invagen PharmsFor profitMKTGNov 13, 2017
LupinFor profitMKTGMay 11, 2007
MerckFor profitSYNOct 7, 2011
MerckFor profitMKTGJul 23, 2004
MerckFor profitNDADec 23, 1991
Micro Labs Ltd IndiaFor profitMKTGSep 16, 2011
MylanFor profitSYNDec 17, 2020
MylanFor profitSYNOct 14, 2015
MylanFor profitMKTGJun 8, 2010
OrganonFor profitNDA2Dec 23, 1991
Oxford PharmaceuticalsFor profitMKTGAug 30, 2010
Sun PharmaceuticalsFor profitMKTGJun 23, 2006
Tcg Fluent PharmaFor profitMKTGApr 21, 2016
Tcg Fluent PharmaFor profitNDA2Apr 21, 2016
TevaFor profitMKTGJun 23, 2006
TevaFor profitSYNDec 30, 2005
TevaFor profitSYNDec 20, 2006
Viva HealthcareFor profitMKTGSep 16, 2011
Watson PharmaceuticalsFor profitMKTGApr 26, 2017
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGNov 13, 2017
Zydus Discovery DMCCFor profitMKTGDec 20, 2006