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Esomeprazole

Generic Name
Esomeprazole
Brand Names
Nexium, Vimovo, Nexium Control
Drug Type
Small Molecule
Chemical Formula
C17H19N3O3S
CAS Number
119141-88-7
Unique Ingredient Identifier
N3PA6559FT

Overview

Esomeprazole, sold under the brand name Nexium, is a proton pump inhibitor (PPI) medication used for the management of gastroesophageal reflux disease (GERD), for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs, and for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome. It can also be found in quadruple regimens for the treatment of H. pylori infections along with other antibiotics including Amoxicillin, Clarithromycin, and Metronidazole, for example. Its efficacy is considered similar to other medications within the PPI class including Omeprazole, Pantoprazole, Lansoprazole, Dexlansoprazole, and Rabeprazole. Esomeprazole is the s-isomer of Omeprazole, which is a racemate of the S- and R-enantiomer. Esomeprazole has been shown to inhibit acid secretion to a similar extent as Omeprazole, without any significant differences between the two compounds in vitro. Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect persists longer than 24 hours. PPIs such as esomeprazole have also been shown to inhibit the activity of dimethylarginine dimethylaminohydrolase (DDAH), an enzyme necessary for cardiovascular health. DDAH inhibition causes a consequent accumulation of the nitric oxide synthase inhibitor asymmetric dimethylarginie (ADMA), which is thought to cause the association of PPIs with increased risk of cardiovascular events in patients with unstable coronary syndromes. Due to their good safety profile and as several PPIs are available over the counter without a prescription, their current use in North America is widespread. Long term use of PPIs such as esomeprazole has been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal C. difficile), reduced absorption of micronutrients such as iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life. Rapid discontinuation of PPIs such as esomeprazole may cause a rebound effect and a short term increase in hypersecretion. Esomeprazole doses should be slowly lowered, or tapered, before discontinuing to prevent this rebound effect.

Indication

Esomeprazole is indicated for the treatment of acid-reflux disorders including healing and maintenance of erosive esophagitis, and symptomatic gastroesophageal reflux disease (GERD), peptic ulcer disease, H. pylori eradication, prevention of gastrointestinal bleeds with NSAID use, and for the long-term treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome.

Associated Conditions

  • Duodenal Ulcer
  • Erosive Esophagitis
  • Gastro-esophageal Reflux Disease (GERD)
  • Heartburn
  • Helicobacter Pylori Infection
  • Stress Ulcers
  • Upper Gastrointestinal Hemorrhage
  • Zollinger-Ellison Syndrome
  • Acute benign gastric ulcers
  • Develop NSAID-induced gastric ulcers
  • Maintenance of healing Erosive esophagitis
  • Postendoscopy Bleeding

Research Report

Published: Jul 15, 2025

Comprehensive Monograph: Esomeprazole (DB00736)

Executive Summary

Esomeprazole (DrugBank ID: DB00736) is a highly utilized small molecule drug belonging to the proton pump inhibitor (PPI) class of medications. It functions as a potent and long-acting inhibitor of gastric acid secretion. Chemically, esomeprazole is the pure (S)-enantiomer of omeprazole, a distinction that forms the basis of its pharmacokinetic profile and marketing as a "chiral switch" product.[1] Its primary mechanism of action involves the irreversible inhibition of the hydrogen-potassium adenosine triphosphatase (

H+/K+-ATPase) enzyme system—the gastric proton pump—located in the secretory canaliculi of gastric parietal cells.[1] As a prodrug, esomeprazole requires activation in the acidic environment of the parietal cell, where it is converted to a reactive sulfenamide that covalently binds to and inactivates the pump, thereby blocking the final step in acid production.[5] This irreversible binding results in a pharmacodynamic effect that lasts over 24 hours, far exceeding its plasma half-life and allowing for convenient once-daily dosing.[1]

The medication is indicated for a wide range of acid-related disorders. Key approved uses include the treatment of gastroesophageal reflux disease (GERD), both for symptomatic relief and for the healing and maintenance of erosive esophagitis (EE).[1] It is also a critical component of triple-therapy regimens for the eradication of

Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, and it is used for the prevention of gastric ulcers associated with chronic nonsteroidal anti-inflammatory drug (NSAID) therapy.[9] Furthermore, it is employed in the management of pathological hypersecretory conditions such as Zollinger-Ellison syndrome.[1]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/12
Phase 1
Recruiting
2025/05/02
Not Applicable
Recruiting
Asian Institute of Gastroenterology, India
2025/05/01
Not Applicable
Recruiting
Asian Institute of Gastroenterology, India
2025/03/31
Phase 2
Not yet recruiting
2025/02/28
Not Applicable
Not yet recruiting
Key Laboratory for Gastrointestinal Diseases of Gansu Province
2025/02/06
Phase 3
ENROLLING_BY_INVITATION
Chang Gung Memorial Hospital
2025/01/27
Phase 1
Completed
2025/01/20
Phase 2
Not yet recruiting
2024/12/13
Phase 1
Active, not recruiting
2024/12/06
Phase 4
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Cisen Pharmaceutical Co., Ltd.
71256-003
ORAL
20 mg in 1 1
1/14/2022
NuCare Pharmaceuticals,Inc.
68071-2922
ORAL
20 mg in 1 1
1/25/2023
Advanced Rx Pharmacy of Tennessee, LLC
80425-0183
ORAL
40 mg in 1 1
11/17/2022
Camber Pharmaceuticals, Inc.
31722-664
ORAL
20 mg in 1 1
1/18/2023
R2 Pharma, LLC
70849-400
ORAL
40 mg in 1 1
9/22/2016
A-S Medication Solutions
50090-5365
ORAL
20 mg in 1 1
12/7/2019
Glenmark Pharmaceuticals Inc., USA
68462-390
ORAL
20 mg in 1 1
9/13/2023
A-S Medication Solutions
50090-5134
ORAL
40 mg in 1 1
7/15/2023
Preferred Pharmaceuticals Inc.
68788-8524
ORAL
40 mg in 1 1
9/14/2023
Ascend Laboratories, LLC
67877-572
ORAL
40 mg in 1 1
3/23/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
8/26/2013

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ESMOZIN POWDER FOR SOLUTION FOR INJECTION AND INFUSION 40 MG/VIAL
SIN16074P
INJECTION, POWDER, FOR SOLUTION
40 mg/vial
1/5/2021
NEXIUM MUPS TABLET 20 mg
SIN11498P
TABLET, FILM COATED
20 mg
4/27/2001
EPIVETIER POWDER FOR SOLUTION FOR INJECTION OR INFUSION 40MG PER VIAL
SIN15395P
INJECTION, POWDER, FOR SOLUTION
40mg
12/14/2017
NEXIUM MUPS TABLET 40 mg
SIN11499P
TABLET, FILM COATED
40 mg
4/27/2001
EMANERA GASTRO-RESISTANT CAPSULES 20 MG
SIN15234P
CAPSULE
20mg
5/12/2017
ESOZ TABLETS 40MG
SIN14633P
TABLET, ENTERIC COATED
40.00mg
9/23/2014
NEXIUM POWDER FOR SOLUTION FOR INJECTION AND INFUSION 40 mg
SIN12616P
INJECTION, POWDER, FOR SOLUTION
40 mg
12/1/2004
SPRAZOLE-20 ESOMEPRAZOLE GASTRO RESISTANT 20 MG TABLETS
SIN16686P
TABLET, DELAYED RELEASE
20 MG
2/8/2023
EMANERA GASTRO-RESISTANT CAPSULES 40 MG
SIN15233P
CAPSULE
40mg
5/12/2017
SPRAZOLE-40 ESOMEPRAZOLE GASTRO RESISTANT 40 MG TABLETS
SIN16685P
TABLET, DELAYED RELEASE
40 MG
2/8/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
AXIAGO 20 mg COMPRIMIDOS GASTRORRESISTENTES
Grünenthal Pharma S.A.
63940
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 20 MG COMPRIMIDOS GASTRORRESISTENTES
Grunenthal Italia S.R.L.
034972291IP
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 20 MG COMPRIMIDOS GASTRORRESISTENTES
Vianex S.A.
84225112-2-12IP2
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM 10 mg GRANULADO GASTRORRESISTENTE PARA SUSPENSION ORAL, SOBRE
Grünenthal Pharma S.A.
69980
GRANULADO PARA SUSPENSIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 40 MG COMPRIMIDOS GASTRORRESISTENTES
Vianex S.A.
842261102022012IP2
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 40 MG COMPRIMIDOS GASTRORRESISTENTES
Grunenthal
BE215887
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 40 mg COMPRIMIDOS GASTRORRESISTENTES
Grünenthal Pharma S.A.
63437
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 20 mg COMPRIMIDOS GASTRORRESISTENTES
Grünenthal Pharma S.A.
63436
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 40 MG COMPRIMIDOS GASTRORRESISTENTES
Vianex S.A.
842261102022012
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
NEXIUM MUPS 20 MG COMPRIMIDOS GASTRORRESISTENTES
Grunenthal
BE215826
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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