Prevacid

(lansoprazole)

ApprovedSmall molecule

Lansoprazole reduces stomach acid to treat heartburn, acid reflux, and ulcers. It helps relieve symptoms like chest pain and difficulty swallowing caused by excess stomach acid.[2] Prevacid is currently approved and in use across 32 indications[4].[1]

Prevacid is one of 431 small molecule programs targeting Premature Birth. It is currently in Approved.

Indications

136

Total Trials

Active Trials

430

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Premature BirthApproved

DyspepsiaTerminated

Transient Ischemic AttackActive, not recruiting

Nasal PolyposisActive, not recruiting

Endothelial DysfunctionApproved

Intermediate Coronary SyndromeActive, not recruiting

Angina UnstableActive, not recruiting

Thrombotic DiseaseActive, not recruiting

HemorrhageActive, not recruiting

Angina PectorisActive, not recruiting

Premature BirthApproved

Approved

DyspepsiaApproved

Terminated

Transient Ischemic AttackApproved

Active, not recruiting

Nasal PolyposisPreclinical

Active, not recruiting

Endothelial DysfunctionApproved

Approved

Intermediate Coronary SyndromeApproved

Active, not recruiting

Angina UnstableApproved

Active, not recruiting

Thrombotic DiseaseApproved

Active, not recruiting

HemorrhageApproved

Active, not recruiting

Angina PectorisApproved

Active, not recruiting

Showing 10 of 32 indications

Competition

Competitive Landscape

161 competitors in Asthma

#DrugCompanyPhaseTrials

Prevacid

Takeda

Approved

1 2

Arcoxia

Novartis

Preclinical

—3

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 4

Aclidinium Bromide

AstraZeneca

Preclinical

—5

Lexapro

SShirley Ryan AbilityLab

Preclinical

1 6

Biological Drug

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

1 7

Guanidine Hydrochloride

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 8

Rhinovirus

UUniversity of Virginia

Preclinical

2 9

FP/SAL

GSK

Preclinical

2 10

Spiriva

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Peptic Ulcer

NCT06284876

Q3 2027

N/ARecruiting

Helicobacter Pylori Eradication

NCT05926804

Q4 2028

Phase 3Not yet recruiting

Gastric Ulcer

NCT07730138

Phase 3Not yet recruiting

Gastroesophageal Reflux Disease

NCT07732075

PreclinicalRecruiting

Acute Coronary Syndromes (ACS)

NCT07479056

Clinical

Trials by Indication[1]

Esophagitis18 trials

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT00251719·2,054 enrolled

Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 2·NCT00471094·831 enrolled

Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT02388724·481 enrolled

Show 15 more trials

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT04124926·1,027 enrolled

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT02388737·703 enrolled

Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety

Completed· Takeda logo

Takeda·Phase 4·NCT02679508·208 enrolled

The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis

Completed·JJiangsu Sinorda Biomedicine Co., Ltd·Phase 3·NCT07079540·380 enrolled

A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

Completed·YYongChan Lee·Phase 4·NCT02755753·143 enrolled

A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00641602·1,000 enrolled

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT01459367·607 enrolled

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT00251693·2,038 enrolled

An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01008696·217 enrolled

Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis

Unknown status·NNational Cheng-Kung University Hospital·Phase 4·NCT02759393·200 enrolled

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 3·NCT01452698·409 enrolled

Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis

Completed· Takeda logo

Takeda·Phase 2·NCT00175045·68 enrolled

Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Unknown status· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT04341428·406 enrolled

Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis

Completed·JJiangsu Sinorda Biomedicine Co., Ltd·Phase 2·NCT04531475·90 enrolled

Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis

Terminated· Takeda logo

Takeda·Phase 3·NCT02873702·37 enrolled

Duodenal Ulcer10 trials

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

Completed· Takeda logo

Takeda·Phase 3·NCT01452750·642 enrolled

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection

Completed· Takeda logo

Takeda·Phase 3·NCT03050359·533 enrolled

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)

Completed· Takeda logo

Takeda·Phase 3·NCT01456260·406 enrolled

Show 7 more trials

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

Completed· Takeda logo

Takeda·Phase 3·NCT01452763·621 enrolled

Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

Completed· Takeda logo

Takeda··NCT02099708·3,502 enrolled

Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

Completed· Takeda logo

Takeda·Phase 3·NCT01456247·439 enrolled

Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

Completed· Takeda logo

Takeda··NCT02099682·3,366 enrolled

Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

Completed· Takeda logo

Takeda·Phase 3·NCT01452724·372 enrolled

A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers

Terminated· Takeda logo

Takeda·Phase 3·NCT00762359·461 enrolled

Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

Completed· Takeda logo

Takeda·Phase 3·NCT00787254·366 enrolled

Peptic ulcer6 trials

Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment

Recruiting·MMario Steffanus·N/A·NCT06894992·162 enrolled

Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer

Recruiting·IIl-Yang Pharm. Co., Ltd.·Phase 3·NCT06284876·416 enrolled

Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)

Withdrawn·—·Phase 4·NCT01123031

Show 3 more trials

Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT04784910·423 enrolled

Oral Versus IV Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis

Unknown status·NNational Taiwan University Hospital·Phase 3·NCT01182597·190 enrolled

A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs

Completed·HHK inno.N Corporation·Phase 3·NCT04840550·392 enrolled

Helicobacter Pylori Infection6 trials

Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Unknown status·IIncheon St.Mary's Hospital·N/A·NCT04674774·217 enrolled

The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection

Not yet recruiting·—·Phase 3·NCT06964334·70 enrolled

Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

Completed·FFinni Kollins·Phase 2/3·NCT05861687·51 enrolled

Show 3 more trials

Intraluminal Therapy for Helicobacter Pylori Infection

Completed·MMackay Memorial Hospital·Phase 4·NCT03124420·100 enrolled

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT04167670·1,046 enrolled

High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175927·312 enrolled

Helicobacter Pylori Eradication5 trials

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175901·215 enrolled

Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Completed·DDeva Holding A.S.·Phase 3·NCT01131026·60 enrolled

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02633930·566 enrolled

Show 2 more trials

Helicobacter Pylori Eradication Study

Completed·IInje University·Phase 4·NCT03130452·423 enrolled

A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile

Recruiting·MMiguel O'Ryan Gallardo·N/A·NCT05926804·500 enrolled

58 more indications

Gastroesophageal Reflux Disease5 trials

The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease

Completed·SSeoul National University Hospital·N/A·NCT01039558·30 enrolled

Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms

Completed· Takeda logo

Takeda··NCT01990339·14,965 enrolled

A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease

Completed· Takeda logo

Takeda·Phase 1·NCT00174928·24 enrolled

Show 2 more trials

A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.

Completed· Takeda logo

Takeda·Phase 1·NCT00220818·24 enrolled

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis

Not yet recruiting·OOnconic Therapeutics Inc.·Phase 3·NCT07732075·384 enrolled

Efficacy4 trials

Efficacy of Lansoprazole in Chronic Post Nasal Drip

Completed·VVanderbilt University·Phase 3·NCT00335283·75 enrolled

Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Completed·IIl-Yang Pharm. Co., Ltd.·Phase 3·NCT01509261·292 enrolled

Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

Completed· Takeda logo

Takeda·Phase 3·NCT01505127·650 enrolled

Show 1 more trial

The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

Unknown status·—·Phase 4·NCT05820048·300 enrolled

Tics4 trials

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants

Completed·PPhathom Pharmaceuticals, Inc.·Phase 1·NCT04729101·44 enrolled

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT03487562·48 enrolled

Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03059303·72 enrolled

Show 1 more trial

Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00952913·24 enrolled

Gastric Ulcer4 trials

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer

Completed· Takeda logo

Takeda·Phase 3·NCT01452711·482 enrolled

Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer

Completed·OOnconic Therapeutics Inc.·Phase 3·NCT05448001·329 enrolled

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection

Completed· Takeda logo

Takeda·Phase 3·NCT03050307·234 enrolled

Show 1 more trial

A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants With Gastric Ulcer

Not yet recruiting· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT07730138·384 enrolled

Interaction3 trials

Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.

Completed·AAscopharm Groupe Novasco·N/A·NCT01175200·82 enrolled

TAK-438 Bismuth Drug Interaction Study

Completed· Takeda logo

Takeda·Phase 1·NCT02892409·30 enrolled

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

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03468777·18 enrolled

Dyspepsia3 trials

Lansoprazole Versus Mosapride for Functional Dyspepsia

Completed·LLotung Poh-Ai Hospital·Phase 4·NCT00663897·329 enrolled

Lansoprazole for Subgroups of Functional Dyspepsia

Terminated·NNational Taiwan University Hospital·Phase 4·NCT01040455·30 enrolled

Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia

Not yet recruiting·RRenJi Hospital·N/A·NCT06931223·200 enrolled

Heartburn3 trials

Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Completed· Novartis logo

Novartis·Phase 3·NCT00701259·852 enrolled

Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

Completed· Novartis logo

Novartis·Phase 2·NCT01037452·120 enrolled

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn

Completed· Novartis logo

Novartis·Phase 3·NCT00390390·576 enrolled

Helicobacter Pylori2 trials

PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

Completed·—·Phase 4·NCT01180179·228 enrolled

Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01667718·161 enrolled

Oral2 trials

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

Completed·JJiangsu Carephar Pharmaceutical Co., Ltd.·Phase 1·NCT05050188·24 enrolled

Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)

Unknown status·FFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·Phase 4·NCT04660461·20 enrolled

Gastric2 trials

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

Completed· Takeda logo

Takeda·Phase 1·NCT02625259·54 enrolled

Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00410592·90 enrolled

Randomized2 trials

A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00625274·100 enrolled

Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children

Withdrawn·OOsaka University·Phase 4·NCT00299845

ART2 trials

A Study of LY2940680 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01681186·30 enrolled

A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04453189·14 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Completed· Takeda logo

Takeda·Phase 3·NCT02139046·1,790 enrolled

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

Completed· Takeda logo

Takeda·Phase 2·NCT02128490·189 enrolled

Gastroesophageal Reflux2 trials

Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

Terminated·AAmerican Institute for Voice and Ear Research·Phase 4·NCT00369265·18 enrolled

Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

Completed·SSeoul National University Hospital·Phase 1/2·NCT01946971·12 enrolled

Triple-Negative Breast Cancer2 trials

A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

Withdrawn·TThe Christie NHS Foundation Trust·Phase 2·NCT03794596

A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

Withdrawn·TThe Christie NHS Foundation Trust·Phase 2·NCT04188119

Peptic Ulcer Disease1 trial

Peptic Ulcer Disease in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Proton Pump Inhibitor

Unknown status·TTaipei Veterans General Hospital, Taiwan·N/A·NCT00854776·300 enrolled

Aspirin1 trial

Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02251184·31 enrolled

Type 1 Diabetes1 trial

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

Terminated·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00837759·7 enrolled

Acute Stress Ulcer and Acute Gastric Mucosal Lesions1 trial

Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]

Completed· Takeda logo

Takeda··NCT02170207·63 enrolled

Rhinitis1 trial

The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate

Unknown status·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT02278081·98 enrolled

Infants1 trial

Lansoprazole in Preterm Infants With Reflux

Completed·SSeoul National University Hospital·Phase 2·NCT01778101·5 enrolled

Inflammation1 trial

Elucidation of Acid-Induced Pulmonary Inflammation

Terminated·UUniversity of Utah·Phase 2/3·NCT00361972·17 enrolled

Reflux1 trial

Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00637845·248 enrolled

Cardiac1 trial

Cardiac Safety of Lansoprazole and Domperidon Combination

Withdrawn·NNeutec Ar-Ge San ve Tic A.Ş·Phase 4·NCT03355170

Double-blind1 trial

Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00644735·750 enrolled

Endothelial Function1 trial

Effect of Proton Pump Inhibitors on Endothelial Function

Completed·SStanford University·Phase 1·NCT02022280·21 enrolled

Medication1 trial

Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children

Completed·HHamilton Health Sciences Corporation·Phase 4·NCT01082029·65 enrolled

Idiopathic Pulmonary Fibrosis1 trial

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

Recruiting·—·Phase 3·NCT04965298·298 enrolled

Nasal polyposis1 trial

Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Completed·HHead and Neck Surgery Associates·N/A·NCT00215787·20 enrolled

Breast Cancer1 trial

The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer

Completed·TTanta University·Phase 3·NCT04874935·66 enrolled

Hoarseness1 trial

Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Terminated·UUniversity of Kansas Medical Center·Phase 4·NCT00637416·9 enrolled

COVID-191 trial

Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients

Completed·RRAAS Nutritionals, LLC·Phase 3·NCT05417997·71 enrolled

Clopidogrel1 trial

Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01147588·149 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions

Completed·—·Phase 1·NCT01270308·48 enrolled

Pneumonia1 trial

Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02555852·4,238,504 enrolled

Cystic Fibrosis1 trial

Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis

Completed·—·Phase 1·NCT00458614·18 enrolled

Intravenous1 trial

Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]

Completed· Takeda logo

Takeda··NCT02151786·1,120 enrolled

Gastritis1 trial

Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids

Completed·YYonsei University·Phase 4·NCT05946135·42 enrolled

Barrett's esophagus1 trial

An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00352261·80 enrolled

Stress1 trial

Lansoprazole Preventing Gastroduodenal Stress Ulcerations

Terminated·TTemple University·Phase 4·NCT00220909·40 enrolled

Obstructive Sleep Apnea1 trial

Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea

Withdrawn·MMetroHealth Medical Center·N/A·NCT00211614

Orthopedic1 trial

Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain

Completed·MMassachusetts General Hospital·Phase 1/2·NCT00685295·60 enrolled

GERD1 trial

Comparison of the Efficiency of Two Different PPI Formula in Atypical GERD

Unknown status·TTaipei Veterans General Hospital, Taiwan·N/A·NCT03418337·120 enrolled

Clinical Trial1 trial

A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）

Unknown status·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT03120273·70 enrolled

TED1 trial

PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers

Completed·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT03488186·24 enrolled

Zollinger-Ellison Syndrome1 trial

Treatment of Zollinger-Ellison Syndrome With Prevacid

Completed·—·Phase 4·NCT00204373·72 enrolled

PK/PD1 trial

A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121

Completed·AAddpharma Inc.·Phase 1·NCT06025773·24 enrolled

Gastrectomy1 trial

PPI Therapy Impact on GERD After Sleeve Gastrectomy

Unknown status·UUniversity of Roma La Sapienza·Phase 1·NCT04400136·45 enrolled

Asthma1 trial

Lansoprazole to Treat Children With Asthma

Completed·JJohns Hopkins University·Phase 4·NCT00442013·306 enrolled

Otitis Media With Effusion1 trial

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Completed·WWashington University School of Medicine·N/A·NCT00546117·16 enrolled

Platelet Reactivity1 trial

Effect of Proton Pump Inhibitor on Residual Platelet Reactivity After Clopidogrel in Homogenous Genetic Strata

Unknown status·UUniversità degli Studi di Ferrara·Phase 4·NCT01512953·522 enrolled

Tonsillectomy1 trial

The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Terminated·—·Phase 4·NCT00472186·2 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Completed· Takeda logo

Takeda·Phase 4·NCT01135368·506 enrolled

Uterine Cancer1 trial

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

Completed·UUniversity Hospital, Ghent·Phase 2·NCT03192059·43 enrolled

GERD (Gastroesophageal Reflux Disease)1 trial

A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Study to Evaluate the Efficacy and Safety of 2 Doses of Linaprazan Glurate Compared to Lansoprazole in 4 or 8 Weeks Healing in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D

Completed·CCinclus Pharma Holding AB·Phase 3·NCT07037875·523 enrolled

Acute Coronary Syndromes (ACS)1 trial

Randomized Active-Controlled Trial Evaluating Fexuprazan for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention-Fexuprazan for Patients With Dual Antiplatelet Therapy Trial

Recruiting·SSUK MIN SEO·Preclinical·NCT07479056·200 enrolled

Erosive Esophagitis1 trial

A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), 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

Completed·CCinclus Pharma AG·Phase 2·NCT05055128·248 enrolled

Unspecified7 trials

Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples

Completed·UUniversity of Western Ontario, Canada·N/A·NCT01216267·200 enrolled

Lansoprazole 30 mg DR Capsule Replicate Food Study

Completed· Teva logo

Teva·Phase 1·NCT01046084·50 enrolled

Lansoprazole 30 mg DR Capsule Fasting Study

Completed· Teva logo

Teva·Phase 1·NCT01045967·56 enrolled

Show 4 more trials

Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects

Completed·PPuma Biotechnology, Inc.·Phase 1·NCT02334501·15 enrolled

Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

Completed· Teva logo

Teva·Phase 1·NCT01046253·50 enrolled

Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

Completed·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT03488173·42 enrolled

13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

Completed·MMeridian Bioscience, Inc.·Phase 4·NCT00825630·123 enrolled

Regulatory

FDA Approval Timeline[5]

May 10, 1995

PREVACID

NDA NDA020406

May 3, 2001

PREVACID

NDA NDA021281

Aug 30, 2002

PREVACID

NDA NDA021428

May 27, 2004

PREVACID IV

NDA NDA021566

May 18, 2009

PREVACID 24 HR

NDA NDA022327

Jun 7, 2016

LANSOPRAZOLE

NDA NDA208025

Sources

References

[1]
ClinicalTrials.gov — 136 trial records for lansoprazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prevacid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — lansoprazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for lansoprazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208025). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Prevacid. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Potassium-Transporting Atpase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

Apr 21, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11077055Apr 21, 2036

11986554Apr 21, 2036

Prevacid

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2028

Trials by Indication[1]

Esophagitis18 trials

Duodenal Ulcer10 trials

Peptic ulcer6 trials

Helicobacter Pylori Infection6 trials

Helicobacter Pylori Eradication5 trials

Gastroesophageal Reflux Disease5 trials

Efficacy4 trials

Tics4 trials

Gastric Ulcer4 trials

Interaction3 trials

Dyspepsia3 trials

Heartburn3 trials

Helicobacter Pylori2 trials

Oral2 trials

Gastric2 trials

Randomized2 trials

ART2 trials

Efficacy and Safety2 trials

Gastroesophageal Reflux2 trials

Triple-Negative Breast Cancer2 trials

Peptic Ulcer Disease1 trial

Aspirin1 trial

Type 1 Diabetes1 trial

Acute Stress Ulcer and Acute Gastric Mucosal Lesions1 trial

Rhinitis1 trial

Infants1 trial

Inflammation1 trial

Reflux1 trial

Cardiac1 trial

Double-blind1 trial

Endothelial Function1 trial

Medication1 trial

Idiopathic Pulmonary Fibrosis1 trial

Nasal polyposis1 trial

Breast Cancer1 trial

Hoarseness1 trial

COVID-191 trial

Clopidogrel1 trial

Fasting Conditions1 trial

Pneumonia1 trial

Cystic Fibrosis1 trial

Intravenous1 trial

Gastritis1 trial

Barrett's esophagus1 trial

Stress1 trial

Obstructive Sleep Apnea1 trial

Orthopedic1 trial

GERD1 trial

Clinical Trial1 trial

TED1 trial

Zollinger-Ellison Syndrome1 trial

PK/PD1 trial

Gastrectomy1 trial

Asthma1 trial

Otitis Media With Effusion1 trial

Platelet Reactivity1 trial

Tonsillectomy1 trial

Safety and Efficacy1 trial

Uterine Cancer1 trial

GERD (Gastroesophageal Reflux Disease)1 trial

Acute Coronary Syndromes (ACS)1 trial

Erosive Esophagitis1 trial

Unspecified7 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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