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olmesartan

Trade name: benicar

Small moleculeapproved

Approved

Apr 25, 2002

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Oral olmesartan medoxomil 10-40 mg once daily is recommended for the treatment of adult patients with hypertension, this dosage has consistently helped achieve a double-digit reduction both in systolic and diastolic blood pressure, a reduction which is maintained for one year. Extensive clinical evidence from several large well designed trials and the clinical practice setting has confirmed the antihypertensive efficacy and good tolerability profile of oral olmesartan medoxomil, as monotherapy in patients with hypertension. Olmesartan medoxomil has shown no clinically important pharmacokinetic interactions with digoxin, warfarin or antacid (aluminium magnesium hydroxide). Adverse events were infrequent in clinical studies of olmesartan medoxomil and were similar to those attributed to placebo. — NCATS

Clinical trial activity

128 trials · 111 clinical orgs · 32 marketing orgs

Phase 1
23
Phase 2
59
Phase 3
50
Phase 4
40

Earliest trial started Mar 1, 2000 (NCT00295542)

Timeline

2000s

  1. Jan 1, 2000

    Daiichi Sankyo — Earliest Phase 3 Sponsor(trial)

  2. Apr 25, 2002

    Earliest FDA Approval

  3. Apr 25, 2002

    Cosette — NDA Secondary Org

  4. Apr 25, 2002

    Daiichi Sankyo — NDA Secondary Org

  5. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2005

    Daiichi Sankyo — Earliest Phase 1 Sponsor(trial)

  7. Sep 16, 2009

    Sandoz — Marketing Organization

2010s

  1. Mar 7, 2011

    Matrix Laboratories Limited — Marketing Organization

  2. Dec 2, 2015

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  3. Oct 26, 2016

    Rising Pharmaceuticals — Marketing Organization

  4. Oct 26, 2016

    Amneal Pharmaceuticals — Marketing Organization

  5. Oct 26, 2016

    Mylan — Marketing Organization

  6. Oct 26, 2016

    Par Pharmaceuticals — Marketing Organization

  7. Oct 26, 2016

    Teva — Marketing Organization

  8. Oct 26, 2016

    Torrent Pharmaceuticals Limited — Marketing Organization

  9. Oct 26, 2016

    Bristol-Myers Squibb — Marketing Organization

  10. Oct 26, 2016

    Neogen — Marketing Organization

  11. Oct 28, 2016

    Ajanta Pharma Ltd — Marketing Organization

  12. Apr 24, 2017

    Accord Research — Marketing Organization

  13. Apr 24, 2017

    Alembic — Marketing Organization

  14. Apr 24, 2017

    Alkem Labs Ltd — Marketing Organization

  15. Apr 24, 2017

    Aurobindo Pharma — Marketing Organization

  16. Apr 24, 2017

    Jubilant Innovation Ltd. — Marketing Organization

  17. Apr 24, 2017

    Prinston Inc — Marketing Organization

  18. Apr 24, 2017

    Zydus Discovery DMCC — Marketing Organization

  19. Apr 27, 2017

    Lupin — Marketing Organization

  20. May 25, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  21. Nov 2, 2017

    Micro Labs Ltd India — Marketing Organization

  22. Jun 29, 2018

    Sciegen Pharmaceticals — Marketing Organization

  23. Jan 10, 2019

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  24. Feb 22, 2019

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  25. Jul 18, 2019

    Umedica Labs Pvt Ltd — Marketing Organization

2020s

  1. Apr 13, 2020

    Novartis — Marketing Organization

  2. May 18, 2020

    Inventia Hlthcare — Marketing Organization

  3. Jan 18, 2023

    MSN Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedApr 25, 2002

Chemistry & pharmacology

Loading structure…

SMILES

CCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NN=NN4)C(O)=O)C(C)(C)O
Mol. weight
446.5016 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
  • 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
  • 4-(hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl)methyl)-1h-imidazole-5-carboxylic acid
  • 4-(hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
  • 4-(hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylic acid
  • benicar
  • benicar
  • benicar
  • benicar
  • cs-088
  • cs866
  • cs-866
  • cs-866
  • cs-866
  • cs-866
  • olmesartaan medoxomil
  • olmesartan
  • olmesartan
  • olmesartan
  • olmesartan
  • olmesartan
  • olmesartan
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmesartan medoxomil
  • olmetec
  • olmetec
  • olmetec
  • olmetec
  • omesartan
  • rnh 6270
  • rnh-6270
  • rnh-6270
  • sevikar
  • sevikar

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05917275Phase 4Oct 31, 2023Radboud University
NCT06275763Phase 4Oct 20, 2023Instituto Nacional de Cardiologia de Laranjeiras, Medical University of Warsaw
NCT05110898Phase 3Apr 1, 2022Brainfarma Industria Química e Farmacêutica S/A
NCT05103332Phase 2Oct 26, 2021Alnylam Pharmaceuticals
NCT05017987Phase 1Jun 19, 2021Autotelicbio, Yangji Hospital
NCT04856969Phase 1Mar 30, 2021Autotelicbio
NCT05189015Phase 4Jan 1, 2021Seoul National University
NCT05033535Phase 2Jul 1, 2020Shenzhen University
NCT04418297Phase 1Jun 30, 2020Celltrion
NCT04161001Phase 3Nov 20, 2019Daewoong Pharmaceutical Co. LTD.
NCT04138888Phase 1Oct 25, 2019Altasciences Company Inc., Pharmtechnology LLC
NCT04174456Phase 4Sep 1, 2019Dong-A University
NCT04120753Phase 4Aug 26, 2019Daewoong Pharmaceutical Co. LTD.
NCT03951051Phase 1May 6, 2019Altasciences Company Inc., Pharmtechnology LLC
NCT03655964Phase 2Aug 20, 2018Aristotle University of Thessaloniki
NCT03753477Phase 1Dec 22, 2017Daewoong Pharmaceutical Co. LTD., Paik hospital
NCT02483936Phase 3Jun 1, 2017EMS S/A
NCT02493322Phase 3Jun 1, 2017EMS S/A
NCT03009487Phase 3Nov 1, 2016Daewoong Pharmaceutical Co. LTD.
NCT03024476Phase 2Sep 1, 2016Daiichi Sankyo, Seoul National University
Showing 20 of 128 trials
Page 1 / 7

Organizations

Research & Development (111)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Daiichi SankyoFor profit433752000
Daewoong Pharmaceutical Co. LTD.For profit111032010
SankyoFor profit10822001
TakedaFor profit8822004
NovartisFor profit7722007
Yonsei UniversityAcademic/Hospital7432011
Catholic University of KoreaAcademic/Hospital4122010
MylanFor profit4412005
PRACSFor profit4012005
Torrent Pharmaceuticals LimitedFor profit4412010
IMFORM GmbHFor profit3012003
Seoul National UniversityAcademic/Hospital3232013
Sungkyunkwan UniversityAcademic/Hospital3132013
Altasciences Company Inc.For profit2012019
Aristotle University of ThessalonikiAcademic/Hospital2222014
AutotelicbioFor profit2212021
Chonbuk National UniversityAcademic/Hospital2022013
Dong-A UniversityAcademic/Hospital2122013
EMS S/AFor profit2212017
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital2012003
111 organizations
Page 1 / 6

Marketing (42)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGApr 24, 2017
Accord ResearchFor profitSYNAug 30, 2018
Ajanta Pharma LtdFor profitMKTGOct 28, 2016
AlembicFor profitSYNApr 24, 2017
AlembicFor profitMKTGApr 24, 2017
Alkem Labs LtdFor profitMKTGApr 24, 2017
Amneal PharmaceuticalsFor profitMKTGOct 26, 2016
Amneal PharmaceuticalsFor profitSYNJul 11, 2023
Aurobindo PharmaFor profitSYNApr 24, 2017
Aurobindo PharmaFor profitMKTGApr 24, 2017
Bristol-Myers SquibbFor profitMKTGOct 26, 2016
CosetteFor profitNDA2Apr 25, 2002
Daiichi SankyoFor profitNDA2Apr 25, 2002
Glenmark PharmaceuticalsFor profitMKTGMay 25, 2017
Inventia HlthcareFor profitMKTGMay 18, 2020
Jubilant Innovation Ltd.For profitMKTGApr 24, 2017
LupinFor profitMKTGApr 27, 2017
MSN LaboratoriesFor profitMKTGJan 18, 2023
Macleods Pharmaceuticals, LtdFor profitMKTGDec 2, 2015
Matrix Laboratories LimitedFor profitMKTGMar 7, 2011
Micro Labs Ltd IndiaFor profitSYNSep 17, 2019
Micro Labs Ltd IndiaFor profitMKTGNov 2, 2017
MylanFor profitSYNOct 26, 2016
MylanFor profitMKTGOct 26, 2016
NeogenFor profitMKTGOct 26, 2016
NovartisFor profitMKTGApr 13, 2020
Par PharmaceuticalsFor profitMKTGOct 26, 2016
Prinston IncFor profitMKTGApr 24, 2017
Qilu Pharmaceutical Co., Ltd.For profitSYNJan 10, 2019
Qilu Pharmaceutical Co., Ltd.For profitMKTGJan 10, 2019
Rising PharmaceuticalsFor profitSYNOct 26, 2016
Rising PharmaceuticalsFor profitMKTGOct 26, 2016
SandozFor profitSYNApr 13, 2020
SandozFor profitMKTGSep 16, 2009
SankyoFor profitNDA—
Sciegen PharmaceticalsFor profitMKTGJun 29, 2018
Sunshine Lake Pharma Co., Ltd.For profitMKTGFeb 22, 2019
Sunshine Lake Pharma Co., Ltd.For profitSYNFeb 22, 2019
TevaFor profitMKTGOct 26, 2016
Torrent Pharmaceuticals LimitedFor profitMKTGOct 26, 2016
Umedica Labs Pvt LtdFor profitMKTGJul 18, 2019
Zydus Discovery DMCCFor profitMKTGApr 24, 2017