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Gastric Ulcer

11
Pipeline Programs
7
Companies
13
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
0
0
7
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
3100%
+ 10 programs with unclassified modality

On Market (1)

Approved therapies currently available

AstraZeneca
NEXIUM IVApproved
esomeprazole sodium
AstraZeneca
intravenous2005

Competitive Landscape

6 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
8 programs
1
4
1
Esomeprazole SodiumPhase 41 trial
EsomeprazolePhase 3Small Molecule1 trial
EsomeprazolePhase 3Small Molecule1 trial
Esomeprazole 20 mgPhase 31 trial
Esomeprazole 40 mgPhase 31 trial
+3 more programs
Active Trials
NCT01435525Completed369Est. Mar 2014
NCT01729182Completed2,363Est. Mar 2017
NCT01964131Completed34Est. Dec 2013
+5 more trials
Hanmi Pharmaceutical
1 program
1
HIP0612Phase 31 trial
Active Trials
NCT05656092Completed199Est. Dec 2024
Onconic Therapeutics
1 program
1
JP-1366 20mgPhase 31 trial
Active Trials
NCT05448001Completed329Est. Jul 2024
Otsuka
OtsukaJapan - Tokushima
1 program
1
Rebamipide and OmeprazolePhase 3Small Molecule1 trial
Active Trials
NCT01150162Completed129Est. Aug 2012
Hanlim Pharm
Hanlim PharmKorea - Seoul
1 program
1
Vonoprazan Test 20mgPhase 11 trial
Active Trials
NCT06642987Completed30Est. Feb 2024
Takeda
TakedaTOKYO, Japan
1 program
TAK-438PHASE_31 trial
Active Trials
NCT01452711Completed482Est. Dec 2012

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstraZenecaEsomeprazole Sodium
Hanmi PharmaceuticalHIP0612
Onconic TherapeuticsJP-1366 20mg
TakedaTAK-438
OtsukaRebamipide and Omeprazole
AstraZenecaEsomeprazole 20 mg
AstraZenecaEsomeprazole
AstraZenecaEsomeprazole 40 mg
AstraZenecaEsomeprazole
Hanlim PharmVonoprazan Test 20mg
AstraZenecaD961H sachet 20 mg
AstraZenecaNexium Capsules LDA Specific Clinical Experience Investigation
AstraZenecaNexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

Clinical Trials (13)

Total enrollment: 7,536 patients across 13 trials

NCT00428701AstraZenecaEsomeprazole Sodium

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

A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer

Start: Mar 2023Est. completion: Dec 2024199 patients
Phase 3Completed

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

Start: Sep 2022Est. completion: Jul 2024329 patients
Phase 3Completed

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

Start: Nov 2011Est. completion: Dec 2012482 patients
Phase 3Completed
NCT01150162OtsukaRebamipide and Omeprazole

Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Start: Oct 2010Est. completion: Aug 2012129 patients
Phase 3Completed
NCT00595517AstraZenecaEsomeprazole 20 mg

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

Start: Oct 2007Est. completion: Sep 2009395 patients
Phase 3Completed

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

Start: Aug 2007Est. completion: Feb 2009343 patients
Phase 3Completed
NCT00441727AstraZenecaEsomeprazole 40 mg

Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

Start: Feb 2007Est. completion: Aug 20082,426 patients
Phase 3Completed

Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer

Start: Mar 2006Est. completion: Nov 2008397 patients
Phase 3Completed
NCT06642987Hanlim PharmVonoprazan Test 20mg

Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mg(Vonoprazan Fumarate) and Vocinti Tablet 20mg in Healthy Adult Subjects.

Start: Oct 2023Est. completion: Feb 202430 patients
Phase 1Completed
NCT01964131AstraZenecaD961H sachet 20 mg

BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects

Start: Oct 2013Est. completion: Dec 201334 patients
Phase 1Completed
NCT01729182AstraZenecaNexium Capsules LDA Specific Clinical Experience Investigation

Nexium Capsules LDA Specific Clinical Experience Investigation

Start: Jan 2013Est. completion: Mar 20172,363 patients
N/ACompleted
NCT01435525AstraZenecaNexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

Start: Sep 2011Est. completion: Mar 2014369 patients
N/ACompleted

Phase Legend

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

Key Insights

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

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.