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
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
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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
APO-LANSOPRAZOLE ODT lansoprazole 15 mg orally disintegrating tablet blister pack | 216788 | Medicine | A | 11/19/2014 | |
LANZOPRAN lansoprazole 15 mg capsule blister pack | 159344 | Medicine | A | 2/12/2010 | |
APO-LANSOPRAZOLE lansoprazole 30 mg capsule strip pack | 159348 | Medicine | A | 2/12/2010 | |
LANSOPRAZOLE ODT GENERICHEALTH lansoprazole 15 mg orally disintegrating tablet blister pack | 216789 | Medicine | A | 11/19/2014 | |
LANZOPRAN lansoprazole 15 mg capsule strip pack | 159347 | Medicine | A | 2/12/2010 | |
ZOPRAL lansoprazole 15 mg enteric capsule blister pack | 166764 | Medicine | A | 1/8/2010 | |
LANSOPRAZOLE ODT GH lansoprazole 30 mg orally disintegrating tablet blister pack | 216792 | Medicine | A | 11/19/2014 | |
ZOTON FasTabs lansoprazole 30 mg orally disintegrating tablets blister pack | 153701 | Medicine | A | 1/14/2009 | |
APO-LANSOPRAZOLE lansoprazole 15 mg capsule blister pack | 159350 | Medicine | A | 2/12/2010 | |
ZOPRAL ODT lansoprazole 15 mg orally disintegrating tablet blister pack | 187430 | Medicine | A | 11/14/2012 |
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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