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losartan

Trade name: cozaar

Small moleculeapproved

Approved

Apr 14, 1995

Losartan is a selective, competitive angiotensin II receptor type 1 (AT1) antagonist. Losartant is recommended as one of several preferred agents for the initial management of hypertension. Administration of losartan reduces the risk of stroke in patients with hypertension and left ventricular hypertrophy. Losartan is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. — NCATS

Clinical trial activity

380 trials · 310 clinical orgs · 33 marketing orgs

Phase 1
75
Phase 2
154
Phase 3
92
Phase 4
93

Earliest trial started Dec 1, 1990 (NCT00882440)

Timeline

1990s

  1. Jan 1, 1990

    Merck — Earliest Phase 3 Sponsor(trial)

  2. Apr 14, 1995

    Merck — Earliest FDA Approval

  3. Apr 14, 1995

    Organon — NDA Secondary Org

  4. Apr 14, 1995

    Merck — NDA Organization

  5. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Apr 6, 2010

    Mylan — Marketing Organization

  2. Apr 6, 2010

    Teva — Marketing Organization

  3. Apr 6, 2010

    Torrent Pharmaceuticals Limited — Marketing Organization

  4. Apr 6, 2010

    West-Ward Pharmaceutical — Marketing Organization

  5. Apr 6, 2010

    Hikma — Marketing Organization

  6. May 21, 2010

    Lupin — Marketing Organization

  7. Aug 11, 2010

    Apotex — Marketing Organization

  8. Aug 19, 2010

    Sandoz — Marketing Organization

  9. Aug 19, 2010

    Novartis — Marketing Organization

  10. Oct 6, 2010

    Alembic — Marketing Organization

  11. Oct 6, 2010

    Aurobindo Pharma — Marketing Organization

  12. Oct 6, 2010

    Strides Pharma Science — Marketing Organization

  13. Oct 6, 2010

    Upsher-Smith Laboratories — Marketing Organization

  14. Oct 6, 2010

    Watson Pharmaceuticals — Marketing Organization

  15. Oct 6, 2010

    Zydus Discovery DMCC — Marketing Organization

  16. Oct 6, 2010

    AiPing Pharm Inc — Marketing Organization

  17. Oct 6, 2010

    Chartwell Pharmaceuticals — Marketing Organization

  18. Jun 6, 2011

    Prinston Inc — Marketing Organization

  19. May 30, 2012

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  20. Sep 18, 2012

    Cadista — Marketing Organization

  21. Sep 18, 2012

    Jubilant Innovation Ltd. — Marketing Organization

  22. Sep 24, 2012

    Viva Healthcare — Marketing Organization

  23. Sep 24, 2012

    Micro Labs Ltd India — Marketing Organization

  24. Mar 1, 2013

    IPCA Laboratories Ltd. — Marketing Organization

  25. Aug 12, 2015

    Hetero Labs Ltd — Marketing Organization

  26. Oct 14, 2015

    Unichem — Marketing Organization

  27. Apr 4, 2019

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

2020s

  1. Feb 23, 2023

    Granules India — Marketing Organization

  2. Aug 14, 2023

    MSN Laboratories — Marketing Organization

  3. Mar 13, 2025

    SCIENTURE — Marketing Organization

  4. Sep 19, 2025

    Graviti Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedApr 14, 1995

Chemistry & pharmacology

Loading structure…

SMILES

CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1
Mol. weight
422.92 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • (2-butyl-4-chloro-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazol-5-yl)methanol
  • (2-butyl-4-chloro-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazol-5-yl)methanol
  • 2-n-butyl-4-chloro-5-hydroxymethyl-1-[(2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl]imidazole
  • 2-n-butyl-4-chloro-5-hydroxymethyl-1-[(2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl]imidazole
  • allisartan
  • cozaar
  • cozaar
  • cozaar
  • cozaar
  • dup-753
  • dup-753
  • dup 89
  • dup 89
  • hgp0608
  • hydrochlorothiazide - losartan
  • hydrochlorothiazide, losartan drug combination
  • hydrochlorothiazide - losartan potassium
  • hydrochlorothiazide, losartan potassium drug combination
  • hyzaar
  • hyzaar
  • hyzaar
  • lorsartan
  • lortaan
  • lorzaar
  • lorzaar
  • losaprex
  • losaprex
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan
  • losartan monopotassium
  • losartan monopotassium
  • losartan monopotassium salt
  • losartan potassium
  • losartan potassium
  • losartan potassium
  • losartan potassium
  • losartan potassium
  • mk-0954
  • mk-0954
  • mk0954a
  • mk1809
  • mk-954h
  • preminent

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07265739Phase 2Apr 30, 2026American Cancer Society, Inc., Harvard University
NCT07300670Phase 1Feb 28, 2026University of Helsinki, University of Turku
NCT07135687Phase 4Oct 31, 2025Rush University
NCT06933706Phase 2Oct 1, 2025Harvard University, United States Army, University of Kentucky
NCT07160361Phase 4Oct 1, 2025Jiao Tong University, Qinghai University, Shaanxi Provincial People's Hospital
NCT07017023Early Phase 1 (Phase 1)Jul 8, 2025University of Oxford
NCT07099859Phase 4Jul 1, 2025Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo
NCT06831864Phase 1Feb 15, 2025Government of India, University of New South Wales, Washington University in St. Louis
NCT06624904Early Phase 1 (Phase 1)Aug 19, 2024Oxford Health Biomedical Research Centre, University of Oxford
NCT06628154Early Phase 1 (Phase 1)Aug 14, 2024Oxford Health Biomedical Research Centre, University of Oxford
NCT06491940N/AAug 1, 2024RESnTEC, Institute of Research
NCT06539806N/AJul 20, 2024Tanta University
NCT06333522Phase 4Jul 1, 2024New York University
NCT06364176Phase 2Jun 3, 2024University of Kansas
NCT05893108Phase 1/Phase 2 (Phase 2)Mar 30, 2024Gadjah Mada University
NCT06438172Phase 3Mar 25, 2024Dongguk University, Hanmi Pharmaceutical
NCT06636812Early Phase 1 (Phase 1)Mar 7, 2024Oxford Health Biomedical Research Centre, University of Oxford
NCT06329076N/AMar 5, 2024University of Electronic Science and Technology of China
NCT06329050N/AMar 5, 2024University of Electronic Science and Technology of China
NCT06150560Phase 3Dec 31, 2023Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)
Showing 20 of 380 trials
Page 1 / 19

Organizations

Research & Development (310)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit493851990
Hanmi PharmaceuticalFor profit282642007
Harvard UniversityAcademic/Hospital141052007
Seoul National UniversityAcademic/Hospital10332007
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government9331995
Boehringer IngelheimFor profit8821998
Jiao Tong UniversityAcademic/Hospital8722004
University of OxfordAcademic/Hospital8732016
National Cancer Institute (NCI)Government7032009
University of Electronic Science and Technology of ChinaAcademic/Hospital7712018
Yonsei UniversityAcademic/Hospital7142007
National Heart, Lung, and Blood Institute (NHLBI)Government6141997
University of MinnesotaAcademic/Hospital6531997
Daiichi SankyoFor profit5522002
Department of DefenseGovernment5322018
Dongguk UniversityAcademic/Hospital5022008
University of CincinnatiAcademic/Hospital5412012
University of Sao PauloAcademic/Hospital5421999
Johns Hopkins UniversityAcademic/Hospital4322008
Korea UniversityAcademic/Hospital4122008
310 organizations
Page 1 / 16

Marketing (39)

OrganizationOrg typeRelationshipDate
AiPing Pharm IncFor profitMKTGOct 6, 2010
AlembicFor profitMKTGOct 6, 2010
ApotexFor profitMKTGAug 11, 2010
ApotexFor profitSYNOct 6, 2010
Aurobindo PharmaFor profitMKTGOct 6, 2010
CadistaFor profitMKTGSep 18, 2012
Chartwell PharmaceuticalsFor profitMKTGOct 6, 2010
Granules IndiaFor profitMKTGFeb 23, 2023
Granules IndiaFor profitSYNSep 29, 2023
Graviti PharmaceuticalsFor profitMKTGSep 19, 2025
Hetero Labs LtdFor profitMKTGAug 12, 2015
HikmaFor profitMKTGApr 6, 2010
HikmaFor profitSYNApr 6, 2010
IPCA Laboratories Ltd.For profitMKTGMar 1, 2013
Jubilant Innovation Ltd.For profitMKTGSep 18, 2012
LupinFor profitMKTGMay 21, 2010
MSN LaboratoriesFor profitMKTGAug 14, 2023
Macleods Pharmaceuticals, LtdFor profitMKTGMay 30, 2012
MerckFor profitNDAApr 14, 1995
Micro Labs Ltd IndiaFor profitMKTGSep 24, 2012
MylanFor profitMKTGApr 6, 2010
NovartisFor profitMKTGAug 19, 2010
OrganonFor profitNDA2Apr 14, 1995
Prinston IncFor profitMKTGJun 6, 2011
SCIENTUREFor profitMKTGMar 13, 2025
SandozFor profitMKTGAug 19, 2010
Strides Pharma ScienceFor profitMKTGOct 6, 2010
Strides Pharma ScienceFor profitSYNOct 6, 2010
TevaFor profitMKTGApr 6, 2010
TevaFor profitSYNApr 6, 2010
Torrent Pharmaceuticals LimitedFor profitMKTGApr 6, 2010
UnichemFor profitMKTGOct 14, 2015
UnichemFor profitSYNOct 14, 2015
Upsher-Smith LaboratoriesFor profitMKTGOct 6, 2010
Viva HealthcareFor profitMKTGSep 24, 2012
Watson PharmaceuticalsFor profitMKTGOct 6, 2010
West-Ward PharmaceuticalFor profitMKTGApr 6, 2010
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGApr 4, 2019
Zydus Discovery DMCCFor profitMKTGOct 6, 2010