Erosive Esophagitis

11
Pipeline Programs
5
Companies
20
Clinical Trials
2 recruiting
3
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
2100%
+ 7 programs with unclassified modality

On Market (3)

Approved therapies currently available

Takeda
DEXILANTApproved
dexlansoprazole
Takeda
Proton Pump Inhibitor [EPC]oral2009
Takeda
DEXILANT SOLUTABApproved
dexlansoprazole
Takeda
oral2016
U
DEXLANSOPRAZOLEApproved
dexlansoprazole
Unknown Company
Proton Pump Inhibitor [EPC]oral2022

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
2 programs
1
1
VonoprazanPhase 45 trials
DexlansoprazolePhase 3Small Molecule1 trial
Active Trials
NCT02873702Terminated37Est. Nov 2017
NCT04198363Completed510Est. Nov 2021
NCT03116841Completed3Est. Dec 2017
+3 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
1
1
EsomeprazolePhase 4Small Molecule1 trial
Nexium 20mgPhase 31 trial
Active Trials
NCT05267613Recruiting50Est. Sep 2027
NCT00641602Completed1,000Est. Aug 2003
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
1
Omeprazole/sodium bicarbonatePhase 41 trial
Active Trials
NCT00693225CompletedEst. Dec 2010
Phathom Pharmaceuticals
Phathom PharmaceuticalsFLORHAM PARK, NJ
3 programs
1
1
VonoprazanPhase 31 trial
VonoprazanPhase 11 trial
VonoprazanN/A1 trial
Active Trials
NCT06660342RecruitingEst. Sep 2034
NCT06391177CompletedEst. Sep 2024
NCT04124926CompletedEst. Aug 2021
Cinclus Pharma
Cinclus PharmaSweden - Stockholm
1 program
1
X842Phase 21 trial
Active Trials
NCT05055128Completed248Est. Sep 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
TakedaVonoprazan
TakedaVonoprazan
Bausch HealthOmeprazole/sodium bicarbonate
AstraZenecaEsomeprazole
AstraZenecaNexium 20mg
TakedaVonoprazan
Phathom PharmaceuticalsVonoprazan
TakedaVonoprazan
TakedaVonoprazan
TakedaDexlansoprazole
TakedaVonoprazan
TakedaVonoprazan
TakedaVonoprazan
Cinclus PharmaX842
TakedaVonoprazan

Showing 15 of 20 trials with date data

Clinical Trials (20)

Total enrollment: 9,822 patients across 20 trials

Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation

Start: Aug 2017Est. completion: Dec 20173 patients
Phase 4Completed

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

Start: Mar 2016Est. completion: Mar 2022208 patients
Phase 4Completed
NCT00693225Bausch HealthOmeprazole/sodium bicarbonate

Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study

Start: Jan 2008Est. completion: Dec 2010
Phase 4Completed

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

Start: Dec 2002Est. completion: Aug 20031,000 patients
Phase 4Completed

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

Start: Jul 2022Est. completion: Sep 202750 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Start: Apr 2020Est. completion: Nov 2021510 patients
Phase 3Completed

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

Start: Oct 2019Est. completion: Aug 2021
Phase 3Completed

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

Start: Apr 2017Est. completion: May 2020234 patients
Phase 3Completed

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

Start: Apr 2017Est. completion: Jul 2019533 patients
Phase 3Completed
NCT02873702TakedaDexlansoprazole

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

Start: Dec 2016Est. completion: Nov 201737 patients
Phase 3Terminated

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

Start: Apr 2015Est. completion: Dec 2018703 patients
Phase 3Completed

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

Start: Mar 2015Est. completion: Jul 2017481 patients
Phase 3Completed

Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)

Start: Jan 2014Est. completion: Mar 201420 patients
Phase 3Completed

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

Start: Aug 2021Est. completion: Sep 2022248 patients
Phase 2Completed

Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)

Start: Jul 2016Est. completion: Oct 2018256 patients
Phase 2Completed

A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily

Start: May 2024Est. completion: Sep 2024
Phase 1Completed

A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring

Start: May 2025Est. completion: Sep 2034
N/ARecruiting

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

Start: Sep 2016Est. completion: Feb 20191,119 patients
N/ACompleted

Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

Start: Mar 2016Est. completion: Oct 20183,183 patients
N/ACompleted

Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

Start: Mar 2016Est. completion: Aug 20181,237 patients
N/ACompleted

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
2 actively recruiting trials targeting 9,822 patients
5 companies competing in this space