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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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/23
Not Applicable
Completed
Jiangsu Sinorda Biomedicine Co., Ltd
2025/05/09
Phase 3
Not yet recruiting
2025/04/17
Not Applicable
Not yet recruiting
2025/03/26
Not Applicable
Recruiting
Mario Steffanus
2025/01/16
Not Applicable
Recruiting
Hualien Tzu Chi General Hospital
2024/02/29
Phase 3
Recruiting
Il-Yang Pharm. Co., Ltd.
2023/09/06
Phase 1
Completed
2023/07/14
Phase 4
Not yet recruiting
2023/07/06
Phase 2
Recruiting
2023/07/03
Not Applicable
Recruiting
Miguel O'Ryan Gallardo

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bryant Ranch Prepack
63629-2341
ORAL
30 mg in 1 1
1/5/2021
A-S Medication Solutions
50090-6079
ORAL
15 mg in 1 1
3/28/2022
American Health Packaging
60687-123
ORAL
30 mg in 1 1
10/17/2023
Asclemed USA, Inc.
76420-621
ORAL
30 mg in 1 1
10/5/2023
Preferred Pharmaceuticals Inc.
68788-6390
ORAL
15 mg in 1 1
1/10/2023
Mylan Pharmaceuticals Inc.
0378-6982
ORAL
30 mg in 1 1
4/20/2022
Zydus Pharmaceuticals USA Inc.
68382-543
ORAL
15 mg in 1 1
11/10/2022
Safeway
21130-564
ORAL
15 mg in 1 1
5/7/2025
Mylan Pharmaceuticals Inc.
0378-8015
ORAL
15 mg in 1 1
5/19/2021
A-S Medication Solutions
50090-2225
ORAL
30 mg in 1 1
6/30/2019

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

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
LANPO GASTRO-RESISTANT CAPSULES 15MG
N/A
N/A
N/A
10/31/2017

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PREVACID FASTAB
takeda pharmaceuticals america inc
02249464
Tablet (Delayed-Release) - Oral
15 MG
11/24/2006
PMS-LANSOPRAZOLE
02395258
Capsule (Delayed Release) - Oral
15 MG
5/15/2013
Q-LANSOPRAZOLE
qd pharmaceuticals ulc
02369001
Capsule (Delayed Release) - Oral
15 MG
N/A
TARO-LANSOPRAZOLE
sun pharma canada inc
02402629
Capsule (Delayed Release) - Oral
30 MG
3/22/2013
MYLAN-LANSOPRAZOLE
Mylan Pharmaceuticals ULC
02353849
Capsule (Delayed Release) - Oral
30 MG
6/18/2010
NTP-LANSOPRAZOLE
teva canada limited
02354756
Capsule (Delayed Release) - Oral
15 MG
N/A
MYLAN-LANSOPRAZOLE FDT
Mylan Pharmaceuticals ULC
02392402
Tablet (Delayed-Release) - Oral
15 MG
N/A
MYLAN-LANSOPRAZOLE
Mylan Pharmaceuticals ULC
02353830
Capsule (Delayed Release) - Oral
15 MG
6/18/2010
LANSOPRAZOLE
sanis health inc
02357690
Capsule (Delayed Release) - Oral
30 MG
11/22/2010
LANSOPRAZOLE-30
sivem pharmaceuticals ulc
02385775
Capsule (Delayed Release) - Oral
30 MG
6/11/2012

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
DOSTAB 30 mg CAPSULAS DURAS GASTRORRESISTENTES EFG
Laboratorios Salvat S.A.
66106
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
OPIREN FLAS 30 mg COMPRIMIDOS BUCODISPERSABLES
Takeda Farmaceutica Espana S.A.
65475
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
LANSOPRAZOL FLAS VIATRIS 30 MG COMPRIMIDOS BUCODISPERSABLES EFG
76843
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
LANSOPRAZOL VIATRIS 30 MG CAPSULAS GASTRORRESISTENTES EFG
74476
CÁPSULA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
MONOLITUM FLAS 15 mg COMPRIMIDOS BUCODISPERSABLES
Laboratorios Salvat S.A.
71367
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Commercialized
LANSOPRAZOL ARISTOGEN 30 MG CAPSULAS DURAS GASTRORRESISTENTES EFG
Aristo Pharma Iberia S.L.
66133
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LANSOPRAZOL MYLAN 30 mg CAPSULAS DURAS GASTRORRESISTENTES EFG
Mylan Pharmaceuticals S.L.
66114
CÁPSULA DURA GASTRORRESISTENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LANSOPRAZOL FLAS COMBIX 30 MG COMPRIMIDOS BUCODISPERSABLES EFG
Laboratorios Combix S.L.U.
80663
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
LANSOPRAZOL CINFA 30 mg CAPSULAS GASTRORRESISTENTES EFG
Laboratorios Cinfa S.A.
66145
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized
LANSOPRAZOL FLAS SALVAT 30 MG COMPRIMIDOS BUCODISPERSABLE
Laboratorios Salvat S.A.
77739
COMPRIMIDO BUCODISPERSABLE
Medicamento Sujeto A Prescripción Médica
Not 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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