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amlodipine

Trade name: norvasc

Small moleculeapproved

Approved

Jul 31, 1992

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular mooth muscle cells than on cardiac muscle cells. Amlodipine is indicated for the treatment of hypertension and coronary artery disease. — NCATS

Clinical trial activity

594 trials · 386 clinical orgs · 68 marketing orgs

Phase 1
168
Phase 2
188
Phase 3
162
Phase 4
186

Earliest trial started Aug 1, 1985 (NCT00000522)

Timeline

1980s

  1. Jan 1, 1985

    Earliest Phase 2 Sponsor(trial)

1990s

  1. Jul 31, 1992

    Pfizer — Earliest FDA Approval

  2. Jul 31, 1992

    Pfizer — NDA Organization

  3. Jul 31, 1992

    Viatris — Marketing Organization

  4. Jul 31, 1992

    Upjohn — Marketing Organization

  5. Jul 31, 1992

    Viatris — NDA Secondary Org

  6. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  7. Mar 3, 1995

    Novartis — Marketing Organization

  8. Mar 3, 1995

    Novartis — NDA Secondary Org

  9. Mar 3, 1995

    Sandoz — NDA Secondary Org

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Oct 31, 2003

    Dr. Reddy's Laboratories — NDA Secondary Org

  3. Jan 30, 2004

    Pharmacia — NDA Secondary Org

  4. Sep 15, 2006

    Dr. Reddy's Laboratories — Marketing Organization

  5. Mar 22, 2007

    Gedeon Richter Ltd. — Marketing Organization

  6. Apr 25, 2007

    Genpharm — Marketing Organization

  7. May 23, 2007

    Apotex — Marketing Organization

  8. May 23, 2007

    Corepharma — Marketing Organization

  9. May 23, 2007

    Impax Laboratories — Marketing Organization

  10. Jun 27, 2007

    Byondis — NDA Secondary Org

  11. Jun 27, 2007

    Byondis — Marketing Organization

  12. Jun 28, 2007

    Teva — Marketing Organization

  13. Jul 9, 2007

    Upsher-Smith Laboratories — Marketing Organization

  14. Jul 9, 2007

    West-Ward Pharmaceutical — Marketing Organization

  15. Jul 9, 2007

    Medarex — Marketing Organization

  16. Jul 11, 2007

    Strides Pharma Science — Marketing Organization

  17. Jul 12, 2007

    Lupin — Marketing Organization

  18. Jul 17, 2007

    Aurobindo Pharma — Marketing Organization

  19. Jul 19, 2007

    Watson Pharmaceuticals — Marketing Organization

  20. Jul 20, 2007

    Chartwell Pharmaceuticals — Marketing Organization

  21. Jul 20, 2007

    Changchun Changsheng Life Science and Technology Co., Ltd. — Marketing Organization

  22. Jul 20, 2007

    Yiling Pharmaceutical Inc. — Marketing Organization

  23. Aug 28, 2007

    Invagen Pharms — Marketing Organization

  24. Sep 4, 2007

    Puracap Pharmaceutical — Marketing Organization

  25. Sep 6, 2007

    Wockhardt — Marketing Organization

  26. Sep 10, 2007

    Fosun — Marketing Organization

  27. Sep 26, 2007

    Cosette — NDA Secondary Org

  28. Sep 26, 2007

    Cipla — Marketing Organization

  29. Sep 26, 2007

    Daiichi Sankyo — Marketing Organization

  30. Nov 30, 2007

    Sun Pharmaceuticals — Marketing Organization

  31. Jan 16, 2008

    Amneal Pharmaceuticals — Marketing Organization

  32. Apr 8, 2009

    Epic Pharma Llc — Marketing Organization

  33. May 4, 2009

    Alkem Labs Ltd — Marketing Organization

  34. Jul 2, 2009

    Orchid Pharma — Marketing Organization

  35. Jul 2, 2009

    Orbion Pharms — Marketing Organization

  36. Oct 16, 2009

    Boehringer Ingelheim — Marketing Organization

  37. Oct 16, 2009

    Boehringer Ingelheim — NDA Secondary Org

2010s

  1. Apr 7, 2010

    Oxford Pharmaceuticals — Marketing Organization

  2. May 21, 2010

    Mylan — Marketing Organization

  3. Jul 29, 2010

    Par Pharmaceuticals — Marketing Organization

  4. Mar 7, 2011

    Matrix Laboratories Limited — Marketing Organization

  5. Apr 12, 2011

    Hikma — Marketing Organization

  6. Apr 15, 2011

    China Resources Zizhu Pharmaceutical Co., Ltd. — Marketing Organization

  7. Apr 13, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  8. Apr 29, 2013

    Accord Research — Marketing Organization

  9. Oct 21, 2013

    Unichem — Marketing Organization

  10. Jan 8, 2014

    Torrent Pharmaceuticals Limited — Marketing Organization

  11. Jan 21, 2015

    Adhera — NDA Secondary Org

  12. Jan 21, 2015

    Adhera — Marketing Organization

  13. Mar 30, 2015

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  14. Apr 3, 2015

    Alembic — Marketing Organization

  15. Jul 23, 2015

    Sovereign Pharmaceuticals — Marketing Organization

  16. Jul 11, 2016

    Polygen Pharmaceuticals — Marketing Organization

  17. Sep 16, 2016

    Hetero Labs Ltd — Marketing Organization

  18. Oct 26, 2016

    Bristol-Myers Squibb — Marketing Organization

  19. Oct 26, 2016

    Neogen — Marketing Organization

  20. Oct 28, 2016

    Ajanta Pharma Ltd — Marketing Organization

  21. May 15, 2017

    Jubilant Innovation Ltd. — Marketing Organization

  22. Jul 5, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  23. Sep 22, 2017

    Zydus Discovery DMCC — Marketing Organization

  24. Nov 2, 2017

    Micro Labs Ltd India — Marketing Organization

  25. May 4, 2018

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  26. May 31, 2018

    Purple Biotech — NDA Secondary Org

  27. May 31, 2018

    Coeptis — NDA Secondary Org

  28. May 31, 2018

    Purple Biotech — Marketing Organization

  29. Dec 3, 2018

    Sciegen Pharmaceticals — Marketing Organization

  30. Jul 8, 2019

    Azurity — Marketing Organization

  31. Jul 8, 2019

    Silvergate Pharmaceuticals — Marketing Organization

  32. Jul 8, 2019

    Azurity — NDA Secondary Org

2020s

  1. Feb 24, 2022

    CMP Therapeutics Ltd — Marketing Organization

  2. Feb 24, 2022

    CMP Therapeutics Ltd — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 31, 1992

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)C1=C(COCCN)NC(C)=C(C1C2=CC=CC=C2Cl)C(=O)OC
Mol. weight
408.876 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

  • 3-ethyl-5-methyl (+-)-2-(2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
  • 3-ethyl-5-methyl (+-)-2-(2-aminoethoxymethyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
  • 3-ethyl 5-methylester, (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
  • 3-ethyl 5-methylester, (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
  • agsav301
  • aliskiren / amlodipine
  • aliskiren / amlodipine / hydrochlorothiazide
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine
  • amlodipine (as besylate) / valsartan
  • amlodipine/atorvastatin
  • amlodipine besilate
  • amlodipine besilate
  • amlodipine besilate
  • amlodipine besilate / valsartan
  • amlodipine besylate
  • amlodipine besylate
  • amlodipine besylate
  • amlodipine besylate
  • amlodipine besylate
  • amlodipine besylate / valsartan / hydrochlorothiazide
  • amlodipine camsylate
  • amlodipine camsylate
  • amlodipine free base
  • amlodipine free base
  • amlodipine maleate
  • amlodipine maleate
  • amlodipine maleate
  • amlodipine maleate
  • amlodipine maleate
  • amlodipine mesilate
  • amlodipine mesylate
  • amlodipine mixture with valsartan
  • amlodipine orotate
  • amlodipine orotate
  • amlodipine / valsartan
  • amlodipine / valsartan / hydrochlorothiazide
  • amlodipino
  • amlodipino
  • amlodipinum
  • amlodipinum
  • amlopidine
  • amlopres
  • amosartan
  • amvaz
  • amvaz
  • astudal 5
  • cj-30060
  • cj-30060
  • d086
  • dp-r212
  • gsk3074477
  • hcp0605
  • hgp0904
  • istin
  • istin
  • lodivikar
  • norvas
  • norvas
  • norvasc
  • norvasc
  • norvasc
  • norvasc
  • racemic amlodipine
  • (rs)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
  • (rs)-3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
  • telmisartan / amlodipine
  • telmisartan /amlodipine besilate
  • ui15aml055mt
  • uk-4834011
  • uk-4834011
  • uk-48340-11
  • uk-48340-11
  • uk-4834026
  • uk-4834026
  • uk-48340-26
  • uk-48340-26
  • yhp1701

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07075965Phase 1Oct 1, 2025University of Rochester
NCT06942377Phase 2Jul 15, 2025Peking University
NCT06646354Phase 3Jan 31, 2025Hyundai
NCT06523465Phase 4Sep 10, 2024People's Liberation Army of China
NCT06424834Phase 2/Phase 3 (Phase 3)Aug 29, 2024American Heart Association, Stanford University
NCT06826872Phase 2Jun 12, 2024Shin Poong Pharmaceuticals
NCT06193044Phase 1May 7, 2024Mahidol University
NCT06618079Phase 1Apr 20, 2024Chonbuk National University, Huons Co.,Ltd.
NCT06236061Phase 3Apr 8, 2024Novartis
NCT06285201Phase 1Mar 27, 2024Jinlin University
NCT06288542N/AMar 1, 2024Cairo University
NCT06150560Phase 3Dec 31, 2023Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)
NCT06112678Phase 1Dec 7, 2023Chong Kun Dang Pharmaceutical
NCT06167265Phase 1Nov 28, 2023Cliantha Research Limited, Genovate Biotechnology Co., Ltd.,
NCT05917275Phase 4Oct 31, 2023Radboud University
NCT06275763Phase 4Oct 20, 2023Instituto Nacional de Cardiologia de Laranjeiras, Medical University of Warsaw
NCT05842525Phase 2Oct 1, 2023Central South University, Hutchison MediPharma
NCT06041529Phase 4Sep 14, 2023Catholic University of Korea, Yuhan Pharmaceutical Company
NCT06012487Phase 1Sep 1, 2023Cedars-Sinai Medical Center
NCT05976438N/AAug 31, 2023University of Cambridge, University of London
Showing 20 of 594 trials
Page 1 / 30

Organizations

Research & Development (386)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit848242001
Chong Kun Dang PharmaceuticalFor profit343442011
Boehringer IngelheimFor profit333331998
Hanmi PharmaceuticalFor profit232142007
PfizerFor profit221832001
Seoul National UniversityAcademic/Hospital19652007
CJ HealthCare Corp.For profit151542012
Yuhan Pharmaceutical CompanyFor profit141332014
Boryung Pharmaceutical CompanyFor profit131242009
Daiichi SankyoFor profit131232002
Jiao Tong UniversityAcademic/Hospital131042009
University of UlsanAcademic/Hospital13142011
Yonsei UniversityAcademic/Hospital13342007
MerckFor profit12932000
Korea UniversityAcademic/Hospital10242007
Peking UniversityAcademic/Hospital10442006
Sponsor GmbHAcademic/Hospital10022003
Catholic University of KoreaAcademic/Hospital8042011
Chungnam National UniversityAcademic/Hospital8032011
Dr. Reddy's LaboratoriesFor profit8812002
386 organizations
Page 1 / 20

Marketing (100)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGApr 29, 2013
Accord ResearchFor profitSYNAug 30, 2018
AdheraFor profitNDA2Jan 21, 2015
AdheraFor profitMKTGJan 21, 2015
Ajanta Pharma LtdFor profitMKTGOct 28, 2016
AlembicFor profitMKTGApr 3, 2015
AlembicFor profitSYNApr 3, 2015
Alkem Labs LtdFor profitMKTGMay 4, 2009
Alkem Labs LtdFor profitSYNAug 14, 2017
Amneal PharmaceuticalsFor profitMKTGJan 16, 2008
Amneal PharmaceuticalsFor profitSYNJun 13, 2023
ApotexFor profitMKTGMay 23, 2007
ApotexFor profitSYNDec 30, 2013
Aurobindo PharmaFor profitMKTGJul 17, 2007
Aurobindo PharmaFor profitSYNSep 5, 2012
AzurityFor profitMKTGJul 8, 2019
AzurityFor profitNDA2Jul 8, 2019
Boehringer IngelheimFor profitMKTGOct 16, 2009
Boehringer IngelheimFor profitNDA2Oct 16, 2009
Bristol-Myers SquibbFor profitMKTGOct 26, 2016
ByondisFor profitNDA2Jun 27, 2007
ByondisFor profitMKTGJun 27, 2007
CMP Therapeutics LtdFor profitMKTGFeb 24, 2022
CMP Therapeutics LtdFor profitNDA2Feb 24, 2022
Changchun Changsheng Life Science and Technology Co., Ltd.For profitMKTGJul 20, 2007
Chartwell PharmaceuticalsFor profitMKTGJul 20, 2007
China Resources Zizhu Pharmaceutical Co., Ltd.For profitMKTGApr 15, 2011
CiplaFor profitMKTGSep 26, 2007
CoeptisGovernmentNDA2May 31, 2018
CorepharmaFor profitMKTGMay 23, 2007
CosetteFor profitNDA2Sep 26, 2007
Daiichi SankyoFor profitMKTGSep 26, 2007
Dr. Reddy's LaboratoriesFor profitNDA2Oct 31, 2003
Dr. Reddy's LaboratoriesFor profitSYNMar 7, 2014
Dr. Reddy's LaboratoriesFor profitMKTGSep 15, 2006
Epic Pharma LlcFor profitMKTGApr 8, 2009
FosunFor profitMKTGSep 10, 2007
Gedeon Richter Ltd.For profitMKTGMar 22, 2007
GenpharmFor profitMKTGApr 25, 2007
Glenmark PharmaceuticalsFor profitMKTGJul 5, 2017
Hetero Labs LtdFor profitMKTGSep 16, 2016
HikmaFor profitSYNJul 9, 2007
HikmaFor profitMKTGApr 12, 2011
Impax LaboratoriesFor profitMKTGMay 23, 2007
Invagen PharmsFor profitMKTGAug 28, 2007
Jubilant Innovation Ltd.For profitMKTGMay 15, 2017
LupinFor profitSYNJan 8, 2014
LupinFor profitSYNFeb 5, 2010
LupinFor profitMKTGJul 12, 2007
Macleods Pharmaceuticals, LtdFor profitMKTGApr 13, 2012
Matrix Laboratories LimitedFor profitMKTGMar 7, 2011
MedarexFor profitMKTGJul 9, 2007
Micro Labs Ltd IndiaFor profitMKTGNov 2, 2017
MylanFor profitMKTGMay 21, 2010
MylanFor profitSYNOct 3, 2005
NeogenFor profitMKTGOct 26, 2016
NovartisFor profitMKTGMar 3, 1995
NovartisFor profitNDA2Mar 3, 1995
Novel Anti-Infective Technologies, LLCFor profitMKTGMar 30, 2015
Orbion PharmsFor profitMKTGJul 2, 2009
Orchid PharmaFor profitMKTGJul 2, 2009
Oxford PharmaceuticalsFor profitMKTGApr 7, 2010
Par PharmaceuticalsFor profitMKTGJul 29, 2010
Par PharmaceuticalsFor profitSYNMar 28, 2013
PfizerFor profitNDAJul 31, 1992
PharmaciaFor profitNDA2Jan 30, 2004
Polygen PharmaceuticalsFor profitMKTGJul 11, 2016
Puracap PharmaceuticalFor profitMKTGSep 4, 2007
Purple BiotechFor profitNDA2May 31, 2018
Purple BiotechFor profitMKTGMay 31, 2018
SandozFor profitNDA2Mar 3, 1995
Sciegen PharmaceticalsFor profitMKTGDec 3, 2018
Silvergate PharmaceuticalsFor profitMKTGJul 8, 2019
Sovereign PharmaceuticalsFor profitMKTGJul 23, 2015
Strides Pharma ScienceFor profitMKTGJul 11, 2007
Strides Pharma ScienceFor profitSYNJul 11, 2007
Sun PharmaceuticalsFor profitMKTGNov 30, 2007
Sun PharmaceuticalsFor profitSYNJul 9, 2007
Sun PharmaceuticalsFor profitSYNJan 31, 2008
Sunshine Lake Pharma Co., Ltd.For profitMKTGMay 4, 2018
Sunshine Lake Pharma Co., Ltd.For profitSYNMay 4, 2018
TevaFor profitMKTGJun 28, 2007
TevaFor profitSYNMay 18, 2007
TevaFor profitSYNMar 30, 2015
Torrent Pharmaceuticals LimitedFor profitMKTGJan 8, 2014
Torrent Pharmaceuticals LimitedFor profitSYNSep 22, 2008
UnichemFor profitMKTGOct 21, 2013
UnichemFor profitSYNOct 21, 2013
UpjohnFor profitMKTGJul 31, 1992
Upsher-Smith LaboratoriesFor profitMKTGJul 9, 2007
ViatrisFor profitMKTGJul 31, 1992
ViatrisFor profitNDA2Jul 31, 1992
Watson PharmaceuticalsFor profitMKTGJul 19, 2007
Watson PharmaceuticalsFor profitSYNJul 5, 2011
West-Ward PharmaceuticalFor profitMKTGJul 9, 2007
WockhardtFor profitMKTGSep 6, 2007
Yiling Pharmaceutical Inc.For profitMKTGJul 20, 2007
Zydus Discovery DMCCFor profitMKTGSep 22, 2017
Zydus Discovery DMCCFor profitSYNJul 9, 2007
Zydus Discovery DMCCFor profitSYNMar 28, 2013