Dyspepsia

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule

1100%

+ 23 programs with unclassified modality

On Market (2)

Approved therapies currently available

NEXIUMApproved

esomeprazole magnesium

AstraZeneca

oral2008

74M Part D

NEXIUM 24HRApproved

esomeprazole magnesium

AstraZeneca

oral2015

Competitive Landscape

18 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

AstraZenecaCAMBRIDGE, United Kingdom

2 programs

Esomeprazole MagnesiumPhase 41 trial

esomeprazolePhase 4Small Molecule1 trial

Active Trials

NCT00443963Withdrawn0Est. Dec 2006

NCT00120315Completed171Est. Mar 2007

Medica CorpMA - Bedford

1 program

KolofortPhase 41 trial

Active Trials

NCT03119766Completed370Est. Jan 2020

SandozAustria - Kundl

5 programs

TegaserodPhase 31 trial

Active Trials

NCT00171470Completed60Est. Aug 2006

NCT00232024Completed1,296Est. May 2006

NCT00232102Completed423Est. Aug 2006

+2 more trials

Zeria PharmaceuticalJapan - Tokyo

2 programs

Z-338Phase 31 trial

Z-338Phase 21 trial

Active Trials

NCT00298194Completed52

NCT01973790Completed207Est. Apr 2017

EMSBrazil - Hortolândia

1 program

FDC Bromopride 10 mg and Simethicone 80 mgPhase 31 trial

Active Trials

NCT02604576Completed339Est. Mar 2019

RedHill BiopharmaIsrael - Tel Aviv

1 program

RHB-105Phase 31 trial

Active Trials

NCT01980095Completed119Est. Aug 2015

OtsukaJapan - Tokushima

1 program

RebamipidePhase 31 trial

Active Trials

NCT00996788Completed55Est. Jan 2012

AstellasChina - Shenyang

1 program

YM443Phase 31 trial

Active Trials

NCT00764374Completed412Est. Dec 2009

Dong-A STKorea - Seoul

1 program

Motilitone 30mgPhase 21 trial

Active Trials

NCT02365701Completed45Est. Feb 2018

UNION therapeuticsDenmark - Hellerup

1 program

LevosulpiridePhase 11 trial

Active Trials

NCT02481583Completed42Est. May 2013

Temple TherapeuticsNetherlands - Geleen

1 program

DesipramineN/A1 trial

Active Trials

NCT00220844Terminated10Est. Jun 2014

City TherapeuticsMA - Cambridge

1 program

MelatoninN/A1 trial

Active Trials

NCT04684199CompletedEst. Apr 2015

AbbottABBOTT PARK, IL

1 program

UBT as a Diagnostic Tool for HP PrevalanceN/A1 trial

Active Trials

NCT02570776Unknown200Est. Feb 2016

electroCoreNJ - Rockaway

1 program

gammaCore®-GN/A1 trial

Active Trials

NCT02388269Completed91Est. Jun 2015

Ironwood PharmaceuticalsMA - Boston

1 program

IW-9179PHASE_21 trial

Active Trials

NCT01712412Terminated10Est. Mar 2014

EisaiChina - Liaoning

1 program

CinitapridePHASE_31 trial

Active Trials

NCT01355276Completed400Est. Oct 2011

NovartisBASEL, Switzerland

1 program

TegaserodPHASE_3

TakedaTOKYO, Japan

1 program

Double dose of PPIPHASE_41 trial

Active Trials

NCT01888237Completed118Est. Sep 2014

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Medica CorpKolofort

TakedaDouble dose of PPI

AstraZenecaEsomeprazole Magnesium

AstraZenecaesomeprazole

EMSFDC Bromopride 10 mg and Simethicone 80 mg

Zeria PharmaceuticalZ-338

RedHill BiopharmaRHB-105

EisaiCinitapride

AstellasYM443

OtsukaRebamipide

SandozTegaserod

Showing 15 of 23 trials with date data

Clinical Trials (23)

Total enrollment: 6,075 patients across 23 trials

NCT03119766 Medica CorpKolofort

Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients

Start: Jun 2017Est. completion: Jan 2020370 patients

Phase 4Completed

NCT01888237 TakedaDouble dose of PPI

High Dose PPI Triple Therapy Versus Sequential Therapy for Helicobacter Pylori Eradication

Start: May 2013Est. completion: Sep 2014118 patients

Phase 4Completed

NCT00443963 AstraZenecaEsomeprazole Magnesium

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

Start: Dec 2006Est. completion: Dec 20060

Phase 4Withdrawn

NCT00120315 AstraZenecaesomeprazole

Proton Pump Inhibitor Treatment Stop

Start: Dec 2003Est. completion: Mar 2007171 patients

Phase 4Completed

NCT02604576 EMSFDC Bromopride 10 mg and Simethicone 80 mg

Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Start: Jan 2017Est. completion: Mar 2019339 patients

Phase 3Completed

NCT01973790 Zeria PharmaceuticalZ-338

Phase III, Long-term, Open-label Safety Study of Z-338

Start: Mar 2014Est. completion: Apr 2017207 patients

Phase 3Completed

NCT01980095 RedHill BiopharmaRHB-105

ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

Start: Nov 2013Est. completion: Aug 2015119 patients

Phase 3Completed

NCT01355276 EisaiCinitapride

Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

Start: Oct 2010Est. completion: Oct 2011400 patients

Phase 3Completed

NCT00764374 AstellasYM443

A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Start: Aug 2008Est. completion: Dec 2009412 patients

Phase 3Completed

NCT00996788 OtsukaRebamipide

Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Start: Oct 2007Est. completion: Jan 201255 patients

Phase 3Completed

NCT00171470 SandozTegaserod

The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

Start: Apr 2005Est. completion: Aug 200660 patients

Phase 3Completed

NCT00232102 SandozTegaserod

Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Start: Sep 2004Est. completion: Aug 2006423 patients

Phase 3Completed

NCT00232037 SandozTegaserod

Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Start: Sep 2004Est. completion: Aug 2006359 patients

Phase 3Completed

NCT00232089 SandozTegaserod

Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Start: May 2004Est. completion: Jun 20061,296 patients

Phase 3Completed

NCT00232024 SandozTegaserod

Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Start: Jan 2004Est. completion: May 20061,296 patients

Phase 3Completed

NCT02365701 Dong-A STMotilitone 30mg

Study of Motilitone to Treat Functional Dyspepsia

Start: Jun 2015Est. completion: Feb 201845 patients

Phase 2Completed

NCT01712412 Ironwood PharmaceuticalsIW-9179

Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

Start: Oct 2012Est. completion: Mar 201410 patients

Phase 2Terminated

NCT00298194 Zeria PharmaceuticalZ-338

The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

Start: Feb 200652 patients

Phase 2Completed

NCT02481583 UNION therapeuticsLevosulpiride

Pharmacokinetic Study of Levosulpiride

Start: Mar 2013Est. completion: May 201342 patients

Phase 1Completed

NCT04684199 City TherapeuticsMelatonin

Melatonin in Pediatric FD Population

Start: Aug 2014Est. completion: Apr 2015

N/ACompleted

NCT02388269 electroCoregammaCore®-G

A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G

Start: Jun 2014Est. completion: Jun 201591 patients

N/ACompleted

NCT02570776 AbbottUBT as a Diagnostic Tool for HP Prevalance

UBT as a Diagnostic Tool for HP Prevalance

Start: Dec 2013Est. completion: Feb 2016200 patients

N/AUnknown

NCT00220844 Temple TherapeuticsDesipramine

Tricyclic Antidepressants (TCAs) on Gastric Emptying

Start: Sep 2005Est. completion: Jun 201410 patients

N/ATerminated

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

10 late-stage (Phase 3) programs, potential near-term approvals

19 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.