Gastroesophageal Reflux Disease

Gastroenterology
23
Pipeline Programs
8
Companies
50
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
0
6
0
3
8
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
7100%
+ 17 programs with unclassified modality

On Market (3)

Approved therapies currently available

Takeda
DEXILANTApproved
dexlansoprazole
Takeda
Proton Pump Inhibitor [EPC]oral2009
AstraZeneca
NEXIUM 24HRApproved
esomeprazole magnesium
AstraZeneca
oral2014
U
RABEPRAZOLE SODIUMApproved
rabeprazole
Unknown Company
oral2015

Competitive Landscape

8 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
8 programs
1
1
3
NEXIUM 24HR(Esomeprazole)Phase 4Small Molecule1 trial
EsomeprazolePhase 4Small Molecule1 trial
NEXIUM 24HR(esomeprazole)Phase 4Small Molecule5 trials
lesogaberanPhase 21 trial
AZD3355Phase 11 trial
+3 more programs
Active Trials
NCT01432392Completed1,000Est. Apr 2012
NCT00768443Completed2,674Est. Feb 2009
NCT00536328Terminated938Est. Jun 2008
+9 more trials
E
EisaiChina - Liaoning
5 programs
1
2
1
1
rabeprazolePhase 4Small Molecule1 trial
RabeprazolePhase 3Small Molecule1 trial
Rabeprazole 20 mgPhase 21 trial
rabeprazole sodiumPhase 21 trial
E3710Phase 11 trial
Active Trials
NCT01390714Completed30Est. Oct 2011
NCT00165841Completed200Est. Jun 2008
NCT00132496Completed111Est. Jul 2006
+2 more trials
Takeda
TakedaTOKYO, Japan
5 programs
1
2
2
1
Dexlansoprazole MRPhase 31 trial
Dexlansoprazole MRPhase 31 trial
SPD557Phase 21 trial
SSP-002358Phase 21 trial
DEXILANT(Lansoprazole)Phase 1Small Molecule5 trials
Active Trials
NCT02615184Recruiting76Est. Oct 2027
NCT02616302Recruiting70Est. Oct 2027
NCT04311541Withdrawn0Est. Jan 2022
+6 more trials
Pfizer
PfizerNEW YORK, NY
1 program
1
IV pantoprazolePhase 4Small Molecule1 trial
Active Trials
NCT02401035Terminated19Est. Jun 2021
Ironwood Pharmaceuticals
1 program
1
IW-3718Phase 21 trial
Active Trials
NCT02637557CompletedEst. Apr 2017
Sanofi
SanofiPARIS, France
2 programs
2
Z0063Phase 11 trial
Z0063Phase 11 trial
Active Trials
NCT03069963Completed24Est. Apr 2017
NCT03065816Completed34Est. May 2017
Phathom Pharmaceuticals
Phathom PharmaceuticalsFLORHAM PARK, NJ
1 program
1
VonoprazanPhase 11 trial
Active Trials
NCT06106022CompletedEst. Apr 2024
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
Full-Thickness-GastroplicationN/A1 trial
Active Trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
PfizerIV pantoprazole
TakedaLansoprazole
TakedaLansoprazole
AstraZenecaesomeprazole
TakedaLansoprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole
AstraZenecaEsomeprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole
AstraZenecaesomeprazole

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 13,991 patients across 50 trials

NCT02401035PfizerIV pantoprazole

PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

Start: May 2017Est. completion: Jun 202119 patients
Phase 4Terminated
NCT03079050TakedaLansoprazole

An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan

Start: Feb 2017Est. completion: Jul 201733 patients
Phase 4Completed
NCT02351960TakedaLansoprazole

Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

Start: Mar 2015Est. completion: Jul 2016296 patients
Phase 4Completed

To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Start: Aug 2011Est. completion: Jan 2012107 patients
Phase 4Completed
NCT01328652TakedaLansoprazole

Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

Start: Jun 2011Est. completion: Jan 201380 patients
Phase 4Unknown

To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole

Start: Nov 2010Est. completion: Jun 2011101 patients
Phase 4Completed

Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients

Start: Apr 2010Est. completion: Jun 2011305 patients
Phase 4Completed

Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

Start: Apr 2008Est. completion: Jul 2008276 patients
Phase 4Completed

Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery

Start: Jan 2008Est. completion: Jul 20110
Phase 4Withdrawn

Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs

Start: Dec 2006Est. completion: Dec 20060
Phase 4Withdrawn

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

Start: Oct 2006Est. completion: May 200790 patients
Phase 4Completed

An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium

Start: Oct 2006Est. completion: Nov 200640 patients
Phase 4Completed

PPI Sequencing Study

Start: Sep 2006Est. completion: May 2007100 patients
Phase 4Completed

Symptom Adapted Therapy in GERD Patients

Start: Aug 2006Est. completion: Aug 2007441 patients
Phase 4Completed

Nexium RESPONSE Trial

Start: May 2006Est. completion: Nov 20071,000 patients
Phase 4Completed

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

Start: Jan 2006Est. completion: Apr 200780 patients
Phase 4Completed

Esomeprazole in PPI Failures - IMPROVE

Start: Dec 2005Est. completion: Feb 2007450 patients
Phase 4Completed

Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

Start: Nov 2005Est. completion: Aug 2006140 patients
Phase 4Completed

Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response

Start: Oct 2005Est. completion: May 20072,000 patients
Phase 4Completed

An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)

Start: Oct 2005Est. completion: Jan 2006350 patients
Phase 4Completed

The Utility of Nexium in Chronic Cough and Reflux Disease

Start: Sep 2005Est. completion: Sep 200840 patients
Phase 4Completed

Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects

Start: Sep 2005Est. completion: Feb 2006100 patients
Phase 4Completed

Validation of RDQ Questionnaire

Start: Sep 2005Est. completion: Nov 2006350 patients
Phase 4Completed

Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Start: Nov 2004Est. completion: Jul 2005330 patients
Phase 4Completed

Esomeprazole for Treatment of GERD in Pediatric Patients

Start: Oct 2004Est. completion: Oct 2005100 patients
Phase 4Completed

NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

Start: Jun 2004Est. completion: Aug 2005120 patients
Phase 4Completed

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

Start: Jun 2004Est. completion: Nov 2004100 patients
Phase 4Completed
NCT00304421Eisairabeprazole

Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD

Start: Jan 2004Est. completion: Sep 200723 patients
Phase 4Completed

Proton Pump Inhibitor Treatment Stop

Start: Dec 2003Est. completion: Mar 2007171 patients
Phase 4Completed

Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients

Start: Nov 2003Est. completion: Oct 2007
Phase 4Completed

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

Start: Apr 2003Est. completion: Aug 2003600 patients
Phase 4Completed
NCT00204373TakedaLansoprazole

Treatment of Zollinger-Ellison Syndrome With Prevacid

Start: Mar 2003Est. completion: Dec 201072 patients
Phase 4Completed

PPI Test in GP Patients

Start: Jan 2003100 patients
Phase 4Completed

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

Start: Dec 2002Est. completion: Jan 2004750 patients
Phase 4Completed

An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Start: Sep 2002Est. completion: Oct 200260 patients
Phase 4Completed

Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

Start: Sep 2002Est. completion: Nov 200260 patients
Phase 4Completed

Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously

Start: Aug 2002Est. completion: Oct 200260 patients
Phase 4Completed

Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

Start: Jul 2002Est. completion: Oct 200260 patients
Phase 4Completed
NCT01135368TakedaLansoprazole

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Start: Jun 2002Est. completion: Sep 2008506 patients
Phase 4Completed

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

Start: Jun 2002Est. completion: Feb 2003248 patients
Phase 4Completed

Barrett's Esophagus - 315 - 3 Way Cross Over

Start: Apr 2002Est. completion: Jun 200332 patients
Phase 4Completed

Barrett's Esophagus - 315 - 3 Way Cross-Over

Start: Mar 2002Est. completion: Apr 200350 patients
Phase 4Completed

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

Start: Jul 2014Est. completion: Feb 2016343 patients
Phase 3Completed
NCT02135107EisaiRabeprazole

A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

Start: Sep 2013Est. completion: Jun 2016517 patients
Phase 3Completed

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

Start: Aug 2012Est. completion: May 20141,398 patients
Phase 3Completed
NCT01459367TakedaLansoprazole

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

Start: Oct 2011Est. completion: Mar 2013607 patients
Phase 3Completed

Efficacy of Esomeprazole in Patients With Frequent Heartburn

Start: Aug 2011Est. completion: Oct 2011340 patients
Phase 3Completed

Efficacy of Esomeprazole in Patients With Frequent Heartburn

Start: Aug 2011Est. completion: Oct 2011341 patients
Phase 3Completed

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

Start: Feb 2010Est. completion: Nov 2011427 patients
Phase 3Completed
NCT00847808TakedaLansoprazole

Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy

Start: Feb 2009Est. completion: Apr 2010178 patients
Phase 3Completed

Related Jobs in Gastroenterology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
8 companies competing in this space