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valsartan

Trade name: diovan

Small moleculeapproved

Approved

Dec 23, 1996

There is no information in the literature about pharmacological and biological application of definite isomer of valsatran, R – form (also known as VALSARTAN, D- or CGP-49309). However there were found, that in the tablets of valsartan, which are used to treat high blood pressure and to heart failure, the R-enantiomer was an impurity. — NCATS

Clinical trial activity

398 trials · 300 clinical orgs · 41 marketing orgs

Phase 1
52
Phase 2
146
Phase 3
114
Phase 4
165

Earliest trial started Jan 1, 1996 (NCT00367562)

Timeline

1990s

  1. Dec 23, 1996

    Novartis — Earliest FDA Approval

  2. Dec 23, 1996

    Novartis — NDA Organization

  3. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 10, 2012

    Torrent Pharmaceuticals Limited — Marketing Organization

  2. Sep 21, 2012

    Mylan — Marketing Organization

  3. Sep 25, 2012

    Teva — Marketing Organization

  4. Mar 21, 2013

    Alembic — Marketing Organization

  5. Mar 21, 2013

    Apotex — Marketing Organization

  6. Mar 21, 2013

    Aurobindo Pharma — Marketing Organization

  7. Mar 21, 2013

    Lupin — Marketing Organization

  8. Mar 28, 2013

    Par Pharmaceuticals — Marketing Organization

  9. Mar 28, 2013

    Strides Pharma Science — Marketing Organization

  10. Apr 19, 2013

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  11. Apr 19, 2013

    Neogen — Marketing Organization

  12. Jun 26, 2014

    Ohm Laboratories, Inc. — Marketing Organization

  13. Jun 26, 2014

    Sun Pharmaceuticals — Marketing Organization

  14. Jan 5, 2015

    Hetero Labs Ltd — Marketing Organization

  15. Jan 5, 2015

    Jubilant Innovation Ltd. — Marketing Organization

  16. Jan 5, 2015

    Watson Pharmaceuticals — Marketing Organization

  17. Jan 5, 2015

    Actavis — Marketing Organization

  18. Mar 30, 2015

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  19. Jun 9, 2015

    Prinston Inc — Marketing Organization

  20. Jul 7, 2015

    Novartis — Marketing Organization

  21. Jan 4, 2016

    Ivax — Marketing Organization

  22. Jan 11, 2016

    Amneal Pharmaceuticals — Marketing Organization

  23. Jun 3, 2016

    Allergan — Marketing Organization

  24. Jun 3, 2016

    Allergan — NDA Secondary Org

  25. Jun 3, 2016

    AbbVie — NDA Secondary Org

  26. Sep 16, 2016

    Invagen Pharms — Marketing Organization

  27. Nov 1, 2016

    Huaren Pharmaceutical Co Ltd — Marketing Organization

  28. Dec 19, 2017

    Carmel Biosciences — NDA Secondary Org

  29. Apr 9, 2018

    Square Pharmaceuticals — Marketing Organization

  30. May 4, 2018

    Unichem — Marketing Organization

  31. Mar 12, 2019

    Alkem Labs Ltd — Marketing Organization

  32. Mar 15, 2019

    Zydus Discovery DMCC — Marketing Organization

  33. Mar 15, 2019

    Cadila Healthcare — Marketing Organization

2020s

  1. Oct 5, 2021

    Dr. Reddy's Laboratories — Marketing Organization

  2. Oct 27, 2021

    Sciegen Pharmaceticals — Marketing Organization

  3. Nov 2, 2021

    Novitium Pharma — Marketing Organization

  4. Nov 2, 2021

    Ani Pharmaceuticals — Marketing Organization

  5. May 28, 2024

    Crystal Life Sciences — Marketing Organization

  6. May 28, 2024

    Laurus Labs Ltd — Marketing Organization

  7. Jul 24, 2024

    MSN Laboratories — Marketing Organization

  8. Aug 5, 2024

    RYAN LABS — Marketing Organization

  9. Aug 30, 2024

    Biocon Limited — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 23, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=NN3)[C@@H](C(C)C)C(O)=O
Mol. weight
435.5188 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

Black box warning

Sources

Also known as

  • amlodipine (as besylate) / valsartan
  • amlodipine besilate / valsartan
  • amlodipine besylate / valsartan / hydrochlorothiazide
  • amlodipine mixture with valsartan
  • amlodipine / valsartan
  • amlodipine / valsartan / hydrochlorothiazide
  • angiotensin
  • angiotensin
  • cardopan
  • cgp 48933
  • cgp-48933
  • cgp-48933
  • cgp-48933
  • diovan
  • diovan
  • diovan
  • diovan
  • diovan
  • diovan
  • diovan
  • diovan
  • exforge
  • exforge
  • exforge
  • n-pentanoyl-n-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-l-valine
  • n-pentanoyl-n-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-l-valine
  • n-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)-n-valeryl-l-valine
  • n-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)-n-valeryl-l-valine
  • orosartan
  • sacubitril / valsartan
  • (s)-n-valeryl-n-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]-methyl}-valine
  • (s)-n-valeryl-n-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]-methyl}-valine
  • valsartan
  • valsartan
  • valsartan
  • valsartan
  • valsartan
  • valsartan
  • valsartan
  • valsartan
  • valsartan
  • valsartanin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07139405Phase 2Feb 28, 2026Myopharm Limited
NCT07192341N/ASep 27, 2025Kafrelsheikh University
NCT06930885Phase 3Jun 12, 2025Hcor Research Institute, Hospital do Coracao
NCT06917664Phase 4Jun 5, 2025Chinese Academy of Medical Sciences
NCT06704633Phase 4Mar 1, 2025Ifakara Health Institute, University of Basel
NCT06863987Phase 3Feb 5, 2025Shandong New Time Pharmaceutical Co., LTD
NCT06712030Phase 3Jan 31, 2025Autonomous University of Madrid
NCT06771245Phase 3Jan 24, 2025Shijiazhuang Pharma Group (CSPC)
NCT06536309Phase 4Dec 31, 2024Harvard University
NCT06693674Phase 3Dec 31, 2024Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)
NCT06716970Phase 3Dec 30, 2024Wuhan Createrna Science and Technology Co., Ltd
NCT06549504Phase 1Aug 31, 2024Ahn-Gook Pharmaceuticals Co.,Ltd
NCT06501651Phase 4Aug 1, 2024Chongqing Medical University, Dazhou Central Hospital, Nanchong Central Hospital, People's Hospital of Leshan, Sichuan University
NCT06193044Phase 1May 7, 2024Mahidol University
NCT06236061Phase 3Apr 8, 2024Novartis
NCT06266988Phase 1Mar 31, 2024Viatris
NCT06053580Phase 2Jan 1, 2024National Heart, Lung, and Blood Institute (NHLBI), University of Washington
NCT06142383Phase 2Dec 14, 2023Novartis
NCT06149104Phase 3Dec 4, 2023Novartis
NCT06035978Phase 4Nov 30, 2023University of Ostrava
Showing 20 of 398 trials
Page 1 / 20

Organizations

Research & Development (300)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit14112452002
Sponsor GmbHAcademic/Hospital13022003
University of UlsanAcademic/Hospital10442006
CJ HealthCare Corp.For profit9922012
Boehringer IngelheimFor profit8721998
Harvard UniversityAcademic/Hospital7532010
Jiao Tong UniversityAcademic/Hospital7722018
National Heart, Lung, and Blood Institute (NHLBI)Government7131999
IlDong Pharmaceutical Co LtdFor profit6622013
LGFor profit6632009
Seoul National UniversityAcademic/Hospital6032008
Yonsei UniversityAcademic/Hospital6432008
Boryung Pharmaceutical CompanyFor profit5432008
Korea UniversityAcademic/Hospital5132007
Sungkyunkwan UniversityAcademic/Hospital5232009
Ahn-Gook Pharmaceuticals Co.,LtdFor profit4422012
BayerFor profit4312001
Catholic University of KoreaAcademic/Hospital4032008
Damanhour UniversityAcademic/Hospital4422012
Inje UniversityAcademic/Hospital4032008
300 organizations
Page 1 / 15

Marketing (56)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Jun 3, 2016
ActavisFor profitMKTGJan 5, 2015
AlembicFor profitMKTGMar 21, 2013
AlembicFor profitSYNMar 21, 2013
Alkem Labs LtdFor profitMKTGMar 12, 2019
AllerganFor profitMKTGJun 3, 2016
AllerganFor profitNDA2Jun 3, 2016
Amneal PharmaceuticalsFor profitMKTGJan 11, 2016
Ani PharmaceuticalsFor profitMKTGNov 2, 2021
ApotexFor profitMKTGMar 21, 2013
Aurobindo PharmaFor profitMKTGMar 21, 2013
Aurobindo PharmaFor profitSYNApr 22, 2016
Biocon LimitedFor profitMKTGAug 30, 2024
Cadila HealthcareFor profitMKTGMar 15, 2019
Carmel BiosciencesFor profitNDA2Dec 19, 2017
Crystal Life SciencesFor profitMKTGMay 28, 2024
Dr. Reddy's LaboratoriesFor profitMKTGOct 5, 2021
Hetero Labs LtdFor profitMKTGJan 5, 2015
Hetero Labs LtdFor profitSYNSep 16, 2016
Huaren Pharmaceutical Co LtdFor profitMKTGNov 1, 2016
Invagen PharmsFor profitMKTGSep 16, 2016
IvaxFor profitMKTGJan 4, 2016
Jubilant Innovation Ltd.For profitMKTGJan 5, 2015
Laurus Labs LtdFor profitMKTGMay 28, 2024
LupinFor profitSYNMar 30, 2015
LupinFor profitMKTGMar 21, 2013
MSN LaboratoriesFor profitMKTGJul 24, 2024
Macleods Pharmaceuticals, LtdFor profitMKTGApr 19, 2013
MylanFor profitMKTGSep 21, 2012
MylanFor profitSYNJan 5, 2015
NeogenFor profitMKTGApr 19, 2013
NovartisFor profitNDADec 23, 1996
NovartisFor profitMKTGJul 7, 2015
Novel Anti-Infective Technologies, LLCFor profitMKTGMar 30, 2015
Novitium PharmaFor profitMKTGNov 2, 2021
Ohm Laboratories, Inc.For profitMKTGJun 26, 2014
Par PharmaceuticalsFor profitSYNJun 1, 2015
Par PharmaceuticalsFor profitMKTGMar 28, 2013
Prinston IncFor profitMKTGJun 9, 2015
RYAN LABSFor profitMKTGAug 5, 2024
Sciegen PharmaceticalsFor profitMKTGOct 27, 2021
Square PharmaceuticalsFor profitMKTGApr 9, 2018
Square PharmaceuticalsFor profitMKTGApr 9, 2018
Strides Pharma ScienceFor profitMKTGMar 28, 2013
Sun PharmaceuticalsFor profitMKTGJun 26, 2014
TevaFor profitSYNSep 25, 2012
TevaFor profitSYNMar 30, 2015
TevaFor profitSYNMar 21, 2013
TevaFor profitMKTGSep 25, 2012
Torrent Pharmaceuticals LimitedFor profitSYNJan 5, 2015
Torrent Pharmaceuticals LimitedFor profitMKTGApr 10, 2012
UnichemFor profitMKTGMay 4, 2018
UnichemFor profitSYNMay 4, 2018
Watson PharmaceuticalsFor profitMKTGJan 5, 2015
Zydus Discovery DMCCFor profitMKTGMar 15, 2019
Zydus Discovery DMCCFor profitSYNMar 15, 2019