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omeprazole

Trade name: prilosec

Small moleculeapproved

Approved

Sep 14, 1989

Omeprazole, sold under the brand names Prilosec and Losec among others, is a medication used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger–Ellison syndrome. It is also used to prevent upper gastrointestinal bleeding in people who are at high risk. Omeprazole is a proton-pump inhibitor (PPI) and its effectiveness is similar to that of other PPIs. It can be taken by mouth or by injection into a vein. It is also available in the fixed-dose combination medication omeprazole/sodium bicarbonate as Zegerid and as Konvomep. — Wikipedia

Clinical trial activity

439 trials · 382 clinical orgs · 38 marketing orgs

Phase 1
213
Phase 2
101
Phase 3
64
Phase 4
87

Earliest trial started Feb 3, 1983 (NCT00001191)

Timeline

1980s

  1. Jan 1, 1983

    Earliest Phase 2 Sponsor(trial)

  2. Sep 14, 1989

    Astra — Earliest FDA Approval

  3. Sep 14, 1989

    AstraZeneca — NDA Secondary Org

  4. Sep 14, 1989

    AstraZeneca — Marketing Organization

  5. Sep 14, 1989

    Astra — NDA Organization

1990s

  1. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Nov 1, 2002

    Lannett Company, Inc. — Marketing Organization

  2. Dec 23, 2002

    Sandoz — Marketing Organization

  3. Dec 23, 2002

    Novartis — Marketing Organization

  4. May 29, 2003

    Mylan — Marketing Organization

  5. Jun 15, 2004

    Salix — NDA Secondary Org

  6. Dec 21, 2004

    Santarus — Marketing Organization

  7. Dec 21, 2004

    Santarus — NDA Secondary Org

  8. Oct 22, 2007

    Dr. Reddy's Laboratories — Marketing Organization

  9. Oct 22, 2007

    Impax Laboratories — Marketing Organization

  10. Oct 22, 2007

    Apotex — Marketing Organization

  11. Dec 4, 2007

    Dexcel Pharma Technologies Ltd. — NDA Secondary Org

  12. Mar 20, 2008

    Covis — Marketing Organization

  13. Mar 20, 2008

    Covis — NDA Secondary Org

  14. Dec 1, 2009

    Bayer — Marketing Organization

  15. Dec 1, 2009

    RILEY CONSUMER — NDA Secondary Org

2010s

  1. May 25, 2010

    Strides Pharma Science — Marketing Organization

  2. May 25, 2010

    Par Pharmaceuticals — Marketing Organization

  3. Feb 8, 2011

    Cumberland Pharmaceuticals — Marketing Organization

  4. Feb 8, 2011

    Cumberland Pharmaceuticals — NDA Secondary Org

  5. Oct 31, 2014

    Glenmark Pharmaceuticals — Marketing Organization

  6. Jul 30, 2015

    Perrigo — Marketing Organization

  7. Aug 19, 2015

    Aurobindo Pharma — Marketing Organization

  8. Aug 25, 2015

    Lupin — Marketing Organization

  9. Jul 15, 2016

    Actavis — Marketing Organization

  10. Jul 15, 2016

    Ajanta Pharma Ltd — Marketing Organization

  11. Jul 15, 2016

    Unicorn Pacific Corporation — Marketing Organization

  12. Jul 15, 2016

    Chartwell Pharmaceuticals — Marketing Organization

  13. Sep 14, 2016

    Genus Oncology, LLC — Marketing Organization

  14. Sep 14, 2016

    Genus Oncology, LLC — NDA Secondary Org

  15. Dec 6, 2016

    Sciegen Pharmaceticals — Marketing Organization

  16. Jun 13, 2017

    Teva — Marketing Organization

  17. Jul 3, 2017

    Esteve Labs — Marketing Organization

  18. Jul 5, 2017

    Dexcel Pharma Technologies Ltd. — Marketing Organization

  19. Mar 16, 2018

    Zydus Discovery DMCC — Marketing Organization

  20. Oct 12, 2018

    Sun Pharmaceuticals — Marketing Organization

  21. Sep 26, 2019

    Hetero Labs Ltd — Marketing Organization

  22. Nov 1, 2019

    RedHill Biopharma — NDA Secondary Org

2020s

  1. Apr 30, 2020

    Guardian Drug — Marketing Organization

  2. Jun 1, 2020

    P&L Development — Marketing Organization

  3. Dec 10, 2020

    Exeltis — Marketing Organization

  4. Aug 30, 2022

    Azurity — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewSep 14, 1989

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2[n-]c([S+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1.COc1ccc2[n-]c([S+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1.[Mg+2]
Mol. weight
713.14 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Over the Counter

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • antra
  • antra
  • emozul
  • h 168/68
  • h 168/68
  • h-168/68
  • h-168/68
  • h 168/68 magnesium
  • h 168/68 magnesium
  • h 168/68 sodium
  • h 168/68 sodium
  • losec
  • losec
  • losec mups
  • losec sodium
  • losec sodium
  • mezzopram
  • mopral
  • mopral
  • omep
  • omep
  • omeprazol
  • omeprazol
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • omeprazole
  • (−)-omeprazole
  • (−)-omeprazole
  • omeprazole magnesium
  • omeprazole magnesium
  • omeprazole magnesium
  • omeprazole magnesium
  • omeprazole s-form
  • omeprazole s-form
  • omeprazole sodium
  • omeprazole sodium
  • omeprazole sodium
  • omeprazole sodium
  • omeprazole sodium
  • omeprazole sodium bicarbonate
  • omeprazolum
  • omeprazolum
  • omeptrazole
  • omeran
  • prilosec
  • prilosec
  • prilosec
  • prilosec otc
  • prilosec otc
  • vecam
  • zanprol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07269756Phase 1Dec 31, 2025Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT07267221Phase 1Dec 1, 2025Daewoong Pharmaceutical Co. LTD.
NCT07223671Phase 1Nov 12, 2025Bristol-Myers Squibb
NCT07260851Phase 1Nov 5, 2025Daewoong Pharmaceutical Co. LTD.
NCT07235748Phase 1Oct 7, 2025Servier
NCT07149415Phase 1Sep 2, 2025Biogen
NCT07142486N/ASep 1, 2025BIO-CAT Inc., McGill University
NCT07156201Phase 1Aug 28, 2025Actio Biosciences, Inc.
NCT07040839Phase 4Jul 31, 2025Rehman Medical Institute - RMI
NCT06943482Phase 4Jul 1, 2025National University of Singapore
NCT07012785N/AJun 30, 2025Southeast University
NCT07010744N/AJun 30, 2025Dhaka Medical College
NCT06999577Phase 4Jun 4, 2025National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Diego
NCT07068841Phase 1May 18, 2025NeuroDawn Pharmaceutical Co., Ltd.
NCT06948006Phase 1Apr 23, 2025AstraZeneca, Parexel
NCT06917963N/AApr 10, 2025Medical University of Gdansk
NCT06383338Phase 1Mar 31, 2025Murdoch University
NCT06690164Phase 4Jan 31, 2025National University of Singapore
NCT06682000Phase 3Jan 1, 2025Daewoong Pharmaceutical Co. LTD.
NCT06671392Phase 3Dec 31, 2024Daewoong Pharmaceutical Co. LTD.
Showing 20 of 439 trials
Page 1 / 22

Organizations

Research & Development (382)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit181731998
Boehringer IngelheimFor profit141322005
Bristol-Myers SquibbFor profit14922006
Johnson and JohnsonFor profit11722004
Eli LillyFor profit9922013
SanofiFor profit9722009
National Cancer Institute (NCI)Government8341995
PfizerFor profit8822003
BayerFor profit7732008
Hengrui Therapeutics, Inc.For profit7712019
Bausch Health CompaniesFor profit6222002
Dr. Reddy's LaboratoriesFor profit6522006
GlaxoSmithKlineFor profit6612006
POZENFor profit6622006
Daewoong Pharmaceutical Co. LTD.For profit5522023
IQVIAFor profit5012010
Isfahan UniversityAcademic/Hospital5522010
Mayo ClinicAcademic/Hospital5432008
MerckFor profit5412007
Tel Aviv UniversityAcademic/Hospital5432007
382 organizations
Page 1 / 20

Marketing (59)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJul 15, 2016
ActavisFor profitSYNJul 31, 2002
Ajanta Pharma LtdFor profitMKTGJul 15, 2016
ApotexFor profitMKTGOct 22, 2007
ApotexFor profitSYNFeb 11, 2019
AstraFor profitNDASep 14, 1989
AstraZenecaFor profitNDA2Sep 14, 1989
AstraZenecaFor profitMKTGSep 14, 1989
Aurobindo PharmaFor profitSYNAug 19, 2016
Aurobindo PharmaFor profitMKTGAug 19, 2015
Aurobindo PharmaFor profitSYNAug 19, 2015
AzurityFor profitNDA2Aug 30, 2022
BayerFor profitMKTGDec 1, 2009
Chartwell PharmaceuticalsFor profitMKTGJul 15, 2016
CovisFor profitMKTGMar 20, 2008
CovisFor profitNDA2Mar 20, 2008
Cumberland PharmaceuticalsFor profitMKTGFeb 8, 2011
Cumberland PharmaceuticalsFor profitNDA2Feb 8, 2011
Dexcel Pharma Technologies Ltd.For profitNDA2Dec 4, 2007
Dexcel Pharma Technologies Ltd.For profitMKTGJul 5, 2017
Dr. Reddy's LaboratoriesFor profitMKTGOct 22, 2007
Dr. Reddy's LaboratoriesFor profitSYNNov 5, 2018
Esteve LabsFor profitMKTGJul 3, 2017
Esteve LabsFor profitSYNJul 3, 2017
ExeltisFor profitMKTGDec 10, 2020
Genus Oncology, LLCFor profitMKTGSep 14, 2016
Genus Oncology, LLCFor profitNDA2Sep 14, 2016
Glenmark PharmaceuticalsFor profitMKTGOct 31, 2014
Guardian DrugFor profitMKTGApr 30, 2020
Hetero Labs LtdFor profitMKTGSep 26, 2019
Impax LaboratoriesFor profitMKTGOct 22, 2007
Lannett Company, Inc.For profitMKTGNov 1, 2002
LupinFor profitMKTGAug 25, 2015
MylanFor profitMKTGMay 29, 2003
MylanFor profitSYNJun 29, 2018
NovartisFor profitMKTGDec 23, 2002
P&L DevelopmentFor profitMKTGJun 1, 2020
Par PharmaceuticalsFor profitMKTGMay 25, 2010
PerrigoFor profitMKTGJul 30, 2015
PerrigoFor profitSYNMay 24, 2022
RILEY CONSUMERFor profitNDA2Dec 1, 2009
RedHill BiopharmaFor profitNDA2Nov 1, 2019
RedHill BiopharmaFor profitSYNNov 1, 2019
SalixFor profitNDA2Jun 15, 2004
SandozFor profitMKTGDec 23, 2002
SantarusFor profitMKTGDec 21, 2004
SantarusFor profitSYNJun 15, 2004
SantarusFor profitNDA2Dec 21, 2004
Sciegen PharmaceticalsFor profitMKTGDec 6, 2016
Strides Pharma ScienceFor profitMKTGMay 25, 2010
Sun PharmaceuticalsFor profitSYNOct 12, 2018
Sun PharmaceuticalsFor profitSYNJul 20, 2018
Sun PharmaceuticalsFor profitMKTGOct 12, 2018
TevaFor profitMKTGJun 13, 2017
TevaFor profitSYNJan 20, 2023
Unicorn Pacific CorporationFor profitMKTGJul 15, 2016
Zydus Discovery DMCCFor profitMKTGMar 16, 2018
Zydus Discovery DMCCFor profitSYNNov 19, 2012
Zydus Discovery DMCCFor profitSYNMar 16, 2018