TheraRadar
Data updated: May 26, 2026

LANSOPRAZOLE

Proton Pump Inhibitors
Gastrointestinal Approved 2009-11-10

Lansoprazole is a proton pump inhibitor (PPI) indicated for the short-term treatment of active duodenal ulcers and active benign gastric ulcers in adults. It is used in combination with amoxicillin and/or clarithromycin for the eradication of *H. pylori* to reduce the risk of duodenal ulcer recurrence. Additionally, it is indicated for the healing and risk reduction of NSAID-associated gastric ulcers. For adults and pediatric patients aged 1 year and older, it is used to treat symptomatic GERD and erosive esophagitis (EE). It is also indicated for the maintenance of healed duodenal ulcers and EE in adults, and the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

Source: FDA Label • Dr. Reddy's • Proton Pump Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How LANSOPRAZOLE Works

Lansoprazole belongs to a class of antisecretory compounds known as substituted benzimidazoles. It suppresses gastric acid secretion by specifically inhibiting the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. As this enzyme system is the "proton pump" within the parietal cell, lansoprazole blocks the final step of acid production. This dose-related effect inhibits both basal and stimulated gastric acid secretion regardless of the stimulus. It does not exhibit anticholinergic or histamine type-2 antagonist activity.

Source: FDA Label
26
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-11-10
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, DELAYED REL PELLETS, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Companies

Dr. Reddy's Sun Pharma MACLEODS PHARMS LTD Teva Apotex ZYDUS HLTHCARE XIROMED PERRIGO R AND D HETERO LABS LTD III Viatris NATCO PHARMA LTD NATCO INVENTIA ANI PHARMS Aurobindo Pharma Novartis ALKEM LABS LTD DEXCEL GLENMARK PHARMS AJANTA PHARMA LTD CHARTWELL MOLECULAR KRKA TOVARNA ZDRAVIL ZYDUS PHARMS NOVITIUM PHARMA LANNETT CO INC
Active Ingredient: LANSOPRAZOLE

LANSOPRAZOLE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
320 FDA actions from 2009 to 2026
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Sep 2025 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling

What LANSOPRAZOLE Treats

6 indications

LANSOPRAZOLE is approved for 6 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Duodenal Ulcer
  • H. pylori Infection
  • Gastric Ulcer
  • Gastroesophageal Reflux Disease
  • Erosive Esophagitis
  • Zollinger-Ellison Syndrome
Source: FDA Label

LANSOPRAZOLE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

10

Same target(s) AND same indication — head-to-head.

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Baxter
2024 4 indic.
KONVOMEP
AZURITY
2022 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

TECHNETIUM TC-99M SULFUR COLLOID KIT
JUBILANT
2023 4 indic.
VOQUEZNA
PHATHOM PHARMACEUTICALS
2023 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to LANSOPRAZOLE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

PREVACID
LANSOPRAZOLE
6 shared
Takeda
Shared indications:
Duodenal UlcerH. pylori InfectionGastric Ulcer +3 more
ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM
5 shared
Cipla
Shared indications:
Erosive EsophagitisGastroesophageal Reflux DiseaseGastric Ulcer +2 more
FAMOTIDINE PRESERVATIVE FREE
FAMOTIDINE
5 shared
Viatris
Shared indications:
Duodenal UlcerGastric UlcerGastroesophageal Reflux Disease +2 more
View all 20 similar drugs Pro
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Clinical Trial Registry

64 trials
Trial Sponsor ID Phase Status Title
NCT05946135 4-2023-0598 Ph 4 completed Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids
NCT04965298 TIPAL 269050-80-06-19 2020-000041-14, 269050 Ph 3 recruiting Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
NCT04188119 IMpALA CFT / sp123 2018-004121-80, 017NovCC107 Ph 2 withdrawn A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer
NCT07079540 X842 SND-X842-301 ChiCTR20210736 Ph 3 completed The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis
NCT04531475 SND-X842-201 Ph 2 completed Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis
NCT06284876 IY-NTNS03 Ph 3 recruiting Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
NCT06964334 vit D supplement h.pylori Ph 3 not yet recruiting The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection
NCT04453189 CR108812 2020-000380-23, 64417184RSV1004 Ph 1 completed A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants
NCT05050188 KFP-2020-H008-HW-101 Ph 1 completed A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008
NCT02679508 results posted Vonoprazan-4003 U1111-1178-8948, JapicCTI-163153 Ph 4 completed Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
NCT05055128 results posted CX842A2201 2020-003319-91 Ph 2 completed A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
NCT05861687 LB.02.01.XV.III.2.2.2/344/2022 Ph 2, Ph 3 completed Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children
NCT04729101 results posted VONO-103 Ph 1 completed Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants
NCT03355170 NEU-05.16 Ph 4 withdrawn Cardiac Safety of Lansoprazole and Domperidon Combination
NCT04874935 34615/4/21 Ph 3 completed The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer
NCT02022280 PPI 23848 1144447-121-DHAXB Ph 1 completed Effect of Proton Pump Inhibitors on Endothelial Function
NCT04124926 results posted EE-301 2019-002579-33 Ph 3 completed Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
NCT05417997 APRON 2020-OK-01 Ph 3 completed Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients
NCT04167670 results posted HP-301 2019-002668-28 Ph 3 completed Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
NCT00472186 results posted 06-11-0513 Ph 4 terminated The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
NCT03192059 PRIMMO 2016-001569-97 Ph 2 completed Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer
NCT03050307 results posted TAK-438_302 U1111-1138-8706, CTR20170100 Ph 3 completed Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
NCT03050359 results posted TAK-438_304 U1111-1139-0293, CTR20170104 Ph 3 completed Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
NCT02388737 results posted TAK-438_305 U1111-1136-5706, CTR20150039 Ph 3 completed Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
NCT01123031 CCH-100118 Ph 4 withdrawn Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)
NCT01681186 results posted 14893 I4J-MC-HHBG Ph 1 completed A Study of LY2940680 in Healthy Participants
NCT01180179 NNH_RCT Ph 4 completed PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
NCT03487562 DW_DWP14012003 Ph 1 completed Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
NCT02388724 results posted TAK-438_303 U1111-1138-4788, CTR20150040 Ph 3 completed Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
NCT02873702 results posted TAK-390MR_301 U1111-1142-0320 Ph 3 terminated Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
NCT02892409 results posted TAK-438_115 U1111-1179-5816, 02892409 Ph 1 completed TAK-438 Bismuth Drug Interaction Study
NCT03468777 CR108437 2017-004832-12, 64041575RSV1010 Ph 1 terminated A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants
NCT03124420 17MMHIS020 Ph 4 completed Intraluminal Therapy for Helicobacter Pylori Infection
NCT02625259 results posted MLN1117-1002 U1111-1159-5909 Ph 1 completed A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants
NCT00685295 FAIRTOP results posted FAIRTOP Ph 1, Ph 2 completed Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain
NCT00637416 results posted 10720 Ph 4 terminated Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
NCT02633930 KY20151203-2 Ph 4 completed Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy
NCT02139046 results posted FEB-XR_301 U1111-1152-4040 Ph 3 completed Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
NCT02128490 results posted FEB-XR_201 U1111-1152-3942 Ph 2 completed Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
NCT02334501 PUMA-NER-0101 Ph 1 completed Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects
NCT02755753 REPAIR 037-OTC-1201i Ph 4 completed A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis
NCT02175927 rjkls2014007 Ph 4 completed High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection
NCT01082029 07-435 Ph 4 completed Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
NCT02175901 rjkls2014006 Ph 4 completed Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication
NCT01946971 Konect-LASP Ph 1, Ph 2 completed Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
NCT01456247 TAK-438/OCT-302 U1111-1123-9658, JapicCTI-111616 Ph 3 completed Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
NCT01456260 TAK-438/OCT-301 U1111-1123-8762, JapicCTI-111611 Ph 3 completed Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
NCT01040455 200907053M Ph 4 terminated Lansoprazole for Subgroups of Functional Dyspepsia
NCT01452750 TAK-438/CCT-301 U1111-1123-8722, JapicCTI-111613 Ph 3 completed Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
NCT01452763 TAK-438/CCT-302 U1111-1123-8746, JapicCTI-111610 Ph 3 completed Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

Showing 50 of 64 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LANSOPRAZOLE FDA Label Details

Indications & Usage

FDA Label (PDF)

LANSOPRAZOLE is indicated for the treatment of Duodenal Ulcer; H. pylori Infection; Gastric Ulcer; Gastroesophageal Reflux Disease; Erosive Esophagitis; Zollinger-Ellison Syndrome.

View full patent landscape →
2 OB patents · 1 families · 10 international docs across 4 countries

LANSOPRAZOLE Patents & Exclusivity

Latest Patent: Apr 2036

Patents (2 active)

US11077055 Expires Apr 21, 2036
US11986554 Expires Apr 21, 2036
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2036
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: ANDA091269 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.