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Lansoprazole

Generic Name
Lansoprazole
Brand Names
Prevacid, Prevpac
Drug Type
Small Molecule
Chemical Formula
C16H14F3N3O2S
CAS Number
103577-45-3
Unique Ingredient Identifier
0K5C5T2QPG

Overview

Lansoprazole marketed under the brand Prevacid, is a proton pump inhibitor (PPI) and is structurally classified as a substituted benzimidazole. It reduces gastric acid secretion by targeting gastric H,K-ATPase pumps and is thus effective at promoting healing in ulcerative diseases, and treating gastroesophageal reflux disease (GERD) along with other pathologies caused by excessive acid secretion.

Indication

Lansoprazole is used to reduce gastric acid secretion and is approved for short term treatment of active gastric ulcers, active duodenal ulcers, erosive reflux oesophagitis, symptomatic gastroesophageal reflux disease, and non-steroidal anti-inflammatory drug (NSAID) induced gastric and duodenal ulcers. It may be used in the maintenance and healing of several gastric conditions including duodenal ulcers, NSAID related gastric ulcers, and erosive esophagitis. Lansoprazole prevents recurrence of gastric ulcers in patients who have a documented history of gastric ulcers who also use NSAIDs chronically. Predictably, it is also useful in the management of hypersecretory conditions including Zollinger-Ellison syndrome. Lansoprazole is effective at eradicating H. pylori when used in conjunction with amoxicillin and clarithromycin (triple therapy) or with amoxicillin alone (dual therapy).

Associated Conditions

  • Duodenal Ulcer
  • Erosive Esophagitis
  • Helicobacter Pylori Infection
  • Symptomatic Gastroesophageal Reflux Disease (sGERD)
  • Ulcer Healing
  • Zollinger-Ellison Syndrome
  • Active Duodenal ulcer
  • Develop NSAID-induced gastric ulcers
  • Hypersecretory conditions
  • Maintenance of healing Erosive esophagitis

Research Report

Published: May 29, 2025

Lansoprazole: A Comprehensive Pharmacological and Clinical Review

1. Introduction and Overview

Lansoprazole is a widely utilized pharmaceutical agent belonging to the class of proton pump inhibitors (PPIs). It is primarily prescribed for the management of conditions related to excessive gastric acid secretion.

  • Generic Name: Lansoprazole [1]
  • Brand Names: Lansoprazole is marketed under various brand names globally, with Prevacid® being one of the most recognized. Other common names include Prevacid 24HR (an over-the-counter formulation), Prevacid SoluTab (an orally disintegrating tablet), and Prevacid OTC.[1] During its development, it was also known by the code AG 1749.[1] The availability of multiple brand names, including over-the-counter (OTC) options, reflects its extensive clinical use and established profile for certain indications. However, this also necessitates careful patient education to prevent inadvertent duplication of therapy or inappropriate self-medication if a patient is also prescribed a PPI.
  • DrugBank ID: DB00448 [1]
  • CAS Number: 103577-45-3 [1]
  • Chemical Type: Lansoprazole is a small molecule drug [User Query]. Structurally, it is classified as a substituted benzimidazole.[1] It exists as a racemic 1:1 mixture of its two enantiomers, dexlansoprazole (the R-enantiomer) and levolansoprazole (the S-enantiomer).[1] The benzimidazole core is a common structural feature among many PPIs, which may imply shared mechanistic properties and, theoretically, a potential for cross-reactivity in hypersensitivity reactions, although specific data on lansoprazole cross-reactivity were not detailed in the provided materials. The existence of dexlansoprazole as a separately marketed, enantiomerically pure drug suggests potential pharmacokinetic or pharmacodynamic distinctions from the racemic mixture.
  • Brief Summary of Use and Therapeutic Class: As a proton pump inhibitor, lansoprazole effectively reduces the production of stoma

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2015/09/22
N/A
Completed
Canadian Network for Observational Drug Effect Studies, CNODES
2015/03/17
Phase 3
Completed
2015/03/17
Phase 3
Completed
2015/01/08
Phase 1
Completed
2014/10/29
Phase 4
UNKNOWN
McGill University Health Centre/Research Institute of the McGill University Health Centre
2014/09/29
Phase 4
Completed
2014/06/26
Phase 4
Completed
Shanghai Jiao Tong University School of Medicine
2014/06/26
Phase 4
Completed
Shanghai Jiao Tong University School of Medicine
2014/06/23
N/A
Completed
2014/05/30
N/A
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dr.Reddy's Laboratories Ltd.
55111-399
ORAL
30 mg in 1 1
3/21/2022
Zydus Pharmaceuticals USA Inc.
68382-771
ORAL
15 mg in 1 1
8/22/2022
Camber Pharmaceuticals, Inc.
31722-571
ORAL
30 mg in 1 1
7/24/2020
Ascend Laboratories, LLC
67877-274
ORAL
15 mg in 1 1
7/29/2022
Teva Pharmaceuticals USA, Inc.
0093-7351
ORAL
30 mg in 1 1
3/31/2022
Bryant Ranch Prepack
63629-2340
ORAL
30 mg in 1 1
1/5/2021
Advanced Rx Pharmacy of Tennessee, LLC
80425-0148
ORAL
15 mg in 1 1
11/17/2022
Rising Pharma Holdings, Inc.
16571-698
ORAL
30 mg in 1 1
10/13/2023
A-S Medication Solutions
50090-4596
ORAL
15 mg in 1 1
10/14/2020
NuCare Pharmaceuticals,Inc.
68071-2734
ORAL
15 mg in 1 1
5/25/2022

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
LANSOPRAZOL DISTRIQUIMICA 30 MG CAPSULAS DURAS GASTRORRESISTENTES EFG
83144
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
DOSTAB FLAS 30 MG COMPRIMIDOS BUCODISPERSABLES
Laboratorios Salvat S.A.
78396
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
OPIREN 30 MG CAPSULAS
36286-00-00IP
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
PROCESOL 30 MG CAPSULAS DURAS GASTRORRESISTENTES EFG
86448
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LANSOPRAZOL FLAS SANDOZ 30 MG COMPRIMIDOS BUCODISPERSABLES EFG
Sandoz Farmaceutica S.A.
78839
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LANSOPRAZOL TEVA-RATIOPHARM 15 mg CAPSULAS DURAS GASTRORRESISTENTES EFG
Teva Pharma S.L.U.
66147
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
OPIREN FLAS 30 MG COMPRIMIDOS BUCODISPERSABLES
Takeda France S.A.S.
3400939239989IP2
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LANSOPRAZOL MABO 30 mg CAPSULAS DURAS GASTRORRESISTENTES EFG
Mabo Farma S.A.
66224
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
LANSOPRAZOL ALMUS 15 mg CAPSULAS DURAS GASTRORRESISTENTES EFG
Almus Farmaceutica S.A.U.
70761
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
LANSOPRAZOL CINFAMED 30 mg CAPSULAS GASTRORRESISTENTES EFG
Laboratorios Cinfa S.A.
66350
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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