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esomeprazole

Trade name: nexium

Small moleculeapproved

Approved

Feb 20, 2001

Esomeprazole, sold under the brand name Nexium [or Neksium] among others, is a medication which reduces stomach acid. It is used to treat gastroesophageal reflux disease, peptic ulcer disease, and Zollinger–Ellison syndrome. Its effectiveness is similar to that of other proton pump inhibitors (PPIs). It is taken by mouth or injection into a vein. — Wikipedia

Clinical trial activity

460 trials · 329 clinical orgs · 49 marketing orgs

Phase 1
111
Phase 2
131
Phase 3
97
Phase 4
162

Earliest trial started Dec 1, 1998 (NCT00473980)

Timeline

2000s

  1. Jan 1, 2000

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  2. Feb 20, 2001

    AstraZeneca — Earliest FDA Approval

  3. Feb 20, 2001

    AstraZeneca — Marketing Organization

  4. Feb 20, 2001

    AstraZeneca — NDA Organization

  5. Jan 1, 2002

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 30, 2010

    Horizon Pharma — Marketing Organization

  2. Apr 30, 2010

    Horizon Pharma — NDA Secondary Org

  3. Aug 6, 2013

    R2 Pharma LLC — NDA Secondary Org

  4. Aug 6, 2013

    Belcher Pharmaceuticals — Marketing Organization

  5. Aug 6, 2013

    Hanmi Pharmaceutical — Marketing Organization

  6. Aug 6, 2013

    Belcher Pharmaceuticals — NDA Secondary Org

  7. Jan 26, 2015

    Teva — Marketing Organization

  8. Aug 3, 2015

    Mylan — Marketing Organization

  9. Sep 21, 2015

    Hetero Labs Ltd — Marketing Organization

  10. Sep 25, 2015

    Accord Research — Marketing Organization

  11. Sep 25, 2015

    Dr. Reddy's Laboratories — Marketing Organization

  12. Oct 19, 2015

    Torrent Pharmaceuticals Limited — Marketing Organization

  13. Apr 21, 2016

    Aurobindo Pharma — Marketing Organization

  14. Aug 10, 2016

    Eugia Pharma — Marketing Organization

  15. Mar 6, 2017

    Deva Holding A.S. — Marketing Organization

  16. May 17, 2017

    PHARMOBEDIENT — Marketing Organization

  17. Aug 18, 2017

    Perrigo — Marketing Organization

  18. Sep 1, 2017

    Lannett Company, Inc. — Marketing Organization

  19. Oct 20, 2017

    Alkem Labs Ltd — Marketing Organization

  20. Apr 30, 2018

    Sun Pharmaceuticals — Marketing Organization

  21. May 18, 2018

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  22. Mar 5, 2019

    P&L Development — Marketing Organization

  23. Mar 5, 2019

    Actavis — Marketing Organization

  24. Apr 10, 2019

    Amneal Pharmaceuticals — Marketing Organization

  25. May 10, 2019

    Glenmark Pharmaceuticals — Marketing Organization

  26. May 22, 2019

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Mar 23, 2020

    Cipla — Marketing Organization

  2. Apr 1, 2020

    Gland Pharma Ltd — Marketing Organization

  3. Apr 1, 2020

    Fosun — Marketing Organization

  4. Sep 22, 2020

    Cisen Pharmaceutical — Marketing Organization

  5. Oct 2, 2020

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  6. Oct 20, 2020

    Dexcel Pharma Technologies Ltd. — Marketing Organization

  7. Oct 20, 2020

    Dexcel Pharma Technologies Ltd. — NDA Secondary Org

  8. Nov 18, 2020

    Amta — Marketing Organization

  9. Nov 18, 2020

    GUANGZHOU NOVAKEN — Marketing Organization

  10. Feb 26, 2021

    Indchemie Health — Marketing Organization

  11. Mar 19, 2021

    Graviti Pharmaceuticals — Marketing Organization

  12. Mar 31, 2021

    Ethypharm — Marketing Organization

  13. Feb 10, 2022

    Hainan Poly Pharm — Marketing Organization

  14. Feb 10, 2022

    SLATE RUN PHARMA — Marketing Organization

  15. Aug 24, 2022

    AbbVie — Marketing Organization

  16. Oct 6, 2022

    Ajanta Pharma Ltd — Marketing Organization

  17. Mar 15, 2023

    Guardian Drug — Marketing Organization

  18. Mar 15, 2023

    ANDA Repository — Marketing Organization

  19. Mar 28, 2023

    Prinston Inc — Marketing Organization

  20. Sep 29, 2023

    Marksans Pharma — Marketing Organization

  21. Oct 11, 2023

    Sciegen Pharmaceticals — Marketing Organization

  22. Oct 18, 2023

    Granules India — Marketing Organization

  23. Dec 27, 2023

    Zhejiang Yongtai — Marketing Organization

  24. Oct 23, 2024

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  25. Jan 8, 2025

    Epic Pharma Llc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • vimovo

    with naproxen

    Also known as hcp1004, rld2401

Approval history

  • approvedPriority reviewFeb 20, 2001

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2[n-]c([S@@+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1.[Na+]
Mol. weight
367.41 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Prodrug

Sources

Also known as

  • esomelone
  • esomeprazol
  • esomeprazol
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • esomeprazole
  • ésoméprazole
  • ésoméprazole
  • esomeprazole magnesium
  • esomeprazole magnesium
  • esomeprazole magnesium
  • esomeprazole magnesium
  • esomeprazole magnesium dihydrate
  • esomeprazole magnesium dihydrate
  • esomeprazole magnesium dihydrate
  • esomeprazole magnesium dihydrate
  • esomeprazole magnesium dihydrate
  • esomeprazole magnesium dihydrate
  • esomeprazole magnesium hydrate
  • esomeprazole magnesium hydrate
  • esomeprazole (magnesium trihydrate)
  • esomeprazole mg
  • esomeprazole sodium
  • esomeprazole sodium
  • esomeprazole sodium
  • esomeprazole sodium
  • esomeprazole (sodium)
  • esomeprazole strontium
  • esomeprazole strontium
  • esomeprazole strontium
  • esomeprazole strontium
  • esomeprazolum
  • esomeprazolum
  • fm0f67
  • fm0f67
  • h199/18 magnesium trihydrate
  • h199/18 magnesium trihydrate
  • h199/18 sodium
  • h199/18 sodium
  • nexium
  • nexium
  • nexium
  • nexium
  • nexium control
  • nexium control
  • nexium control
  • nexium iv
  • nexium iv
  • nexium i.v.
  • (-)-omeprazole
  • perprazole
  • perprazole
  • (s)-esomeprazole
  • (s)-omeprazole
  • (s)-omeprazole
  • (s)-omeprazole
  • (s)-(−)-omeprazole
  • (s)-(−)-omeprazole
  • ventra

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07312370Phase 4Jan 20, 2026LanZhou University
NCT07248722N/ADec 31, 2025People's Liberation Army of China
NCT07139366Phase 4Sep 30, 2025People's Liberation Army of China
NCT07294846Phase 1Sep 8, 2025Sinorda Biomedicine
NCT07144657Phase 2Sep 1, 2025National Taiwan University
NCT07018635Phase 1Jul 16, 2025Incyte
NCT07268820Phase 4Jul 7, 2025Incheon St.Mary's Hospital
NCT06953986N/AJun 7, 2025Asian Institute of Gastroenterology
NCT06955520N/AApr 30, 2025Asian Institute of Gastroenterology
NCT06903585Phase 2Apr 30, 2025American University of Beirut
NCT06959368Phase 4Mar 25, 2025Asian Institute of Gastroenterology
NCT06851468N/AMar 15, 2025Government of China
NCT06783257Phase 2Feb 28, 2025Shandong New Time Pharmaceutical Co., LTD
NCT06811207Phase 3Feb 1, 2025Chang Gung University
NCT06793943Phase 1Jan 23, 2025Takeda
NCT06733675Phase 1Jan 7, 2025Department of Health and Human Services, VenatoRx Pharmaceuticals, Inc.
NCT06720610Phase 4Dec 9, 2024University of Indonesia
NCT06850480Phase 3Dec 5, 2024Livzon Pharmaceutical Group Inc.
NCT06717269Phase 1Nov 30, 2024Nurix Therapeutics, Inc.
NCT06595004Phase 3Nov 20, 2024Hanmi Pharmaceutical
Showing 20 of 460 trials
Page 1 / 23

Organizations

Research & Development (329)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit1099252000
Seoul National UniversityAcademic/Hospital16652003
Jiao Tong UniversityAcademic/Hospital151312010
People's Liberation Army of ChinaGovernment131222014
POZENFor profit131122007
IQVIAFor profit10032008
TakedaFor profit101032007
Chinese University of Hong KongAcademic/Hospital9832002
Kaohsiung Medical UniversityAcademic/Hospital9322007
National Taiwan UniversityAcademic/Hospital9942004
The University of Hong KongAcademic/Hospital9832003
Shandong UniversityAcademic/Hospital8722013
Yonsei UniversityAcademic/Hospital8432013
CJ HealthCare Corp.For profit7742011
Hanmi PharmaceuticalFor profit7722018
Chang Gung UniversityAcademic/Hospital6532010
Chong Kun Dang PharmaceuticalFor profit6622017
Livzon Pharmaceutical Group Inc.For profit6632010
PfizerFor profit6632008
Taichung Veterans General HospitalAcademic/Hospital6532007
329 organizations
Page 1 / 17

Marketing (64)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGMar 15, 2023
AbbVieFor profitMKTGAug 24, 2022
Accord ResearchFor profitMKTGSep 25, 2015
ActavisFor profitSYNAug 24, 2022
ActavisFor profitMKTGMar 5, 2019
Ajanta Pharma LtdFor profitMKTGOct 6, 2022
Alkem Labs LtdFor profitMKTGOct 20, 2017
Amneal PharmaceuticalsFor profitMKTGApr 10, 2019
AmtaFor profitMKTGNov 18, 2020
AstraZenecaFor profitSYNFeb 20, 2001
AstraZenecaFor profitMKTGFeb 20, 2001
AstraZenecaFor profitNDAFeb 20, 2001
Aurobindo PharmaFor profitSYNOct 16, 2017
Aurobindo PharmaFor profitMKTGApr 21, 2016
Belcher PharmaceuticalsFor profitMKTGAug 6, 2013
Belcher PharmaceuticalsFor profitNDA2Aug 6, 2013
CiplaFor profitMKTGMar 23, 2020
Cisen PharmaceuticalFor profitMKTGSep 22, 2020
Deva Holding A.S.For profitMKTGMar 6, 2017
Dexcel Pharma Technologies Ltd.For profitMKTGOct 20, 2020
Dexcel Pharma Technologies Ltd.For profitSYNOct 20, 2020
Dexcel Pharma Technologies Ltd.For profitNDA2Oct 20, 2020
Dr. Reddy's LaboratoriesFor profitSYNSep 25, 2015
Dr. Reddy's LaboratoriesFor profitMKTGSep 25, 2015
Epic Pharma LlcFor profitMKTGJan 8, 2025
EthypharmFor profitMKTGMar 31, 2021
Eugia PharmaFor profitMKTGAug 10, 2016
FosunFor profitMKTGApr 1, 2020
GUANGZHOU NOVAKENFor profitMKTGNov 18, 2020
Gland Pharma LtdFor profitMKTGApr 1, 2020
Gland Pharma LtdFor profitSYNApr 1, 2020
Glenmark PharmaceuticalsFor profitMKTGMay 10, 2019
Glenmark PharmaceuticalsFor profitSYNMay 10, 2019
Granules IndiaFor profitMKTGOct 18, 2023
Graviti PharmaceuticalsFor profitMKTGMar 19, 2021
Guardian DrugFor profitMKTGMar 15, 2023
Hainan Poly PharmFor profitMKTGFeb 10, 2022
Hanmi PharmaceuticalFor profitMKTGAug 6, 2013
Hetero Labs LtdFor profitMKTGSep 21, 2015
Horizon PharmaFor profitMKTGApr 30, 2010
Horizon PharmaFor profitNDA2Apr 30, 2010
Indchemie HealthFor profitMKTGFeb 26, 2021
Lannett Company, Inc.For profitMKTGSep 1, 2017
Macleods Pharmaceuticals, LtdFor profitMKTGOct 23, 2024
Marksans PharmaFor profitMKTGSep 29, 2023
MylanFor profitSYNAug 3, 2015
MylanFor profitSYNMay 17, 2017
MylanFor profitMKTGAug 3, 2015
P&L DevelopmentFor profitMKTGMar 5, 2019
PHARMOBEDIENTFor profitMKTGMay 17, 2017
PerrigoFor profitMKTGAug 18, 2017
Prinston IncFor profitMKTGMar 28, 2023
R2 Pharma LLCFor profitNDA2Aug 6, 2013
SLATE RUN PHARMAFor profitMKTGFeb 10, 2022
Sciegen PharmaceticalsFor profitMKTGOct 11, 2023
Shijiazhuang Pharma Group (CSPC)For profitMKTGOct 2, 2020
Sun PharmaceuticalsFor profitSYNApr 30, 2018
Sun PharmaceuticalsFor profitSYNMar 18, 2013
Sun PharmaceuticalsFor profitMKTGApr 30, 2018
Sunshine Lake Pharma Co., Ltd.For profitMKTGMay 18, 2018
TevaFor profitMKTGJan 26, 2015
Torrent Pharmaceuticals LimitedFor profitMKTGOct 19, 2015
Zhejiang YongtaiFor profitMKTGDec 27, 2023
Zydus Discovery DMCCFor profitMKTGMay 22, 2019