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Pantoprazole

Generic Name
Pantoprazole
Brand Names
Protonix, Somac Control, Tecta, Pantozol Control, Controloc Control
Drug Type
Small Molecule
Chemical Formula
C16H15F2N3O4S
CAS Number
102625-70-7
Unique Ingredient Identifier
D8TST4O562

Overview

Pantoprazole is a first-generation proton pump inhibitor (PPI) 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, esomeprazole, lansoprazole, dexlansoprazole, and rabeprazole. Pantoprazole 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 cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of pantoprazole to the (H+, K+)-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, pantoprazole's duration of antisecretory effect persists longer than 24 hours. 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 pantoprazole have been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal C. difficile), reduced absorption of micronutrients including iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life. PPIs such as pantoprazole 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. Pantoprazole doses should be slowly lowered, or tapered, before discontinuing as rapid discontinuation of PPIs such as pantoprazole may cause a rebound effect and a short term increase in hypersecretion.

Indication

Pantoprazole Injection: Treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis Pantoprazole for injection is indicated for short-term treatment (7-10 days) of patients having gastroesophageal reflux disease (GERD) with a history of erosive esophagitis, as an alternative to oral medication in patients who are unable to continue taking pantoprazole delayed-release tablets. Safety and efficacy of pantoprazole injection as the initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated at this time. Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome Pantoprazole for injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions. Pantoprazole delayed-release oral suspension: Short-Term Treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) Indicated in adults and pediatric patients five years of age and above for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been determined. Maintenance of healing of erosive esophagitis Indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Pathological hypersecretory conditions including Zollinger-Ellison syndrome Indicated for the long-term treatment of the above conditions.

Associated Conditions

  • Erosive Esophagitis
  • GERD With Erosive Esophagitis
  • Gastro-esophageal Reflux Disease (GERD)
  • Healing
  • Heartburn
  • Helicobacter Pylori Infection
  • Stress Ulcers
  • Zollinger-Ellison Syndrome
  • Conditions where a reduction of gastric acid secretion is required
  • Pathological hypersecretory conditions

Research Report

Published: Jul 30, 2025

Pantoprazole (DB00213): A Comprehensive Pharmacological and Clinical Monograph

Executive Summary

Pantoprazole is a first-generation, substituted benzimidazole proton pump inhibitor (PPI) widely utilized in clinical practice for the management of acid-related gastrointestinal disorders.[1] This monograph provides a comprehensive analysis of its chemical properties, pharmacological action, clinical use, and safety profile. Chemically identified by CAS Number 102625-70-7, pantoprazole's acid-labile nature dictates its formulation in delayed-release, enteric-coated dosage forms to ensure systemic absorption.[3] Its pharmacodynamic effect is rooted in the irreversible, covalent inhibition of the gastric hydrogen-potassium adenosine triphosphatase (

H+/K+-ATPase) enzyme system, the final common pathway for gastric acid secretion.[4] This targeted action effectively suppresses both basal and stimulated acid production, providing potent and long-lasting relief.

The drug's pharmacokinetic profile is characterized by a notable disconnect between its short plasma half-life of approximately one hour and its prolonged duration of antisecretory effect, which extends beyond 24 hours. This is a direct consequence of the irreversible nature of its binding to the proton pump, as the restoration of acid secretion is dependent on the de novo synthesis of new enzyme pumps rather than on plasma drug concentrations.[1] Metabolism is primarily hepatic, mediated extensively by the polymorphic cytochrome P450 enzyme CYP2C19, a factor that introduces significant inter-individual variability in drug exposure and has led to specific dosing recommendations in pediatric poor metabolizers.[4]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/27
Phase 4
Recruiting
Carnot Laboratories
2025/03/04
Phase 1
Recruiting
toqa saad mohammed mohammed
2024/08/01
Phase 2
Not yet recruiting
2024/07/05
Phase 2
Recruiting
United States Naval Medical Center, Portsmouth
2024/05/16
Phase 3
Completed
2023/12/04
Phase 2
Completed
2022/04/29
Not Applicable
Completed
University of Medicine and Pharmacy at Ho Chi Minh City
2022/02/22
Phase 2
Terminated
2021/06/22
Phase 1
Completed
2021/01/28
Phase 4
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
STAT RX USA LLC
16590-939
ORAL
20 mg in 1 1
6/22/2011
Asclemed USA, Inc.
76420-671
ORAL
20 mg in 1 1
3/13/2024
Quality Care Products, LLC
55700-850
ORAL
40 mg in 1 1
3/26/2020
BE Pharmaceuticals Inc.
71839-122
INTRAVENOUS
40 mg in 10 mL
8/17/2023
NuCare Pharmaceuticals,Inc.
68071-4895
ORAL
40 mg in 1 1
2/17/2021
Ajanta Pharma USA Inc.
27241-256
ORAL
40 mg in 1 1
10/30/2023
medsource pharmaceuticals
45865-785
ORAL
40 mg in 1 1
12/20/2018
RPK Pharmaceuticals, Inc.
53002-1419
ORAL
40 mg in 1 1
3/17/2022
DIRECT RX
61919-806
ORAL
20 mg in 1 1
10/14/2019
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
0008-0843
ORAL
20 mg in 1 1
3/31/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
CONTROLOC IV INJECTION 40 mg/vial
SIN11165P
INJECTION
40 mg/vial
10/7/1999
PANTOBEX DELAYED RELEASE TABLET 40MG
SIN16590P
TABLET, DELAYED RELEASE
40 mg
9/1/2022
CONTROLOC TABLET 20 mg
SIN11170P
ENTERIC COATED TABLET
20 mg
10/7/1999
PANTONEX DR-40 TABLET 40MG
SIN14467P
TABLET, DELAYED RELEASE
40 mg
12/23/2013
PANTIN 40 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 40 MG
SIN15041P
TABLET, ENTERIC COATED
40.0 mg
7/4/2016
PANTOTAB GASTRO RESISTANT TABLETS 40 MG
SIN15863P
ENTERIC COATED TABLET
40 mg
12/2/2019
CONTROLOC TABLET 40 mg
SIN08843P
ENTERIC COATED TABLET
40 mg
8/14/1996
PANTOSALA POWDER FOR SOLUTION FOR INJECTION 40 MG/VIAL
SIN14860P
INJECTION, POWDER, FOR SOLUTION
40 mg/ vial
10/6/2015
DUONAZOLE ENTERIC-COATED TABLET 40MG
SIN15277P
TABLET, ENTERIC COATED
40 mg
6/28/2017
PANTIN 20 PANTOPRAZOLE GASTRO-RESISTANT TABLETS 20MG
SIN15042P
TABLET, ENTERIC COATED
20.0 mg
7/4/2016

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
SOMAC CONTROL 20 MG COMPRIMIDOS GASTRORRESISTENTES
09516001
COMPRIMIDO GASTRORRESISTENTE
Sin Receta
Not Commercialized
PANTECTA 20 MG COMPRIMIDOS GASTRORRESISTENTES
Takeda Pharma Sp. Z O.O.
4787IP3
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
PANTOLOC CONTROL 20 MG COMPRIMIDOS GASTRORRESISTENTES
09519001
COMPRIMIDO GASTRORRESISTENTE
Sin Receta
Not Commercialized
PANTOZOL CONTROL 20 MG COMPRIMIDOS GASTRORRESISTENTES
09517001
COMPRIMIDO GASTRORRESISTENTE
Sin Receta
Not Commercialized
PANTOPRAZOL FARMALIDER 40 mg COMPRIMIDOS GASTRORRESISTENTES EFG
Farmalider S.A.
73942
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
PANTOPRAZOL NORMON 40 mg COMPRIMIDOS GASTRORRESISTENTES EFG
Laboratorios Normon S.A.
69548
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
PANTOPRAZOL ALTAN 40 mg POLVO PARA SOLUCION INYECTABLE EFG
Altan Pharmaceuticals Sa
69454
POLVO PARA SOLUCIÓN INYECTABLE
Uso Hospitalario
Not Commercialized
ALAPANZOL 40 mg COMPRIMIDOS GASTRORRESISTENTES EFG
Especialidades Farmaceuticas Centrum S.A.
71056
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
PANTECTA 40 MG COMPRIMIDOS GASTRORRESISTENTES
Takeda Pharma Sp. Z O.O.
R6898IP3
COMPRIMIDO GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
PANTOPRAZOL NORMON 20 mg COMPRIMIDOS GASTRORRESISTENTES EFG
Laboratorios Normon S.A.
71299
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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