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Functional Dyspepsia

13
Pipeline Programs
14
Companies
17
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
1100%
+ 16 programs with unclassified modality

On Market (1)

Approved therapies currently available

Pfizer
NEURONTINApproved
gabapentin
Pfizer
oral2002
20M Part D

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Dong-A ST
Dong-A STKorea - Seoul
3 programs
1
1
Motilitone ®Phase 41 trial
DA-5212Phase 31 trial
Mosapride citrate 5 mg + DA-9701 30 mgN/A1 trial
Active Trials
NCT07096921Active Not Recruiting92Est. Mar 2026
NCT05842408Completed384Est. Sep 2024
NCT01817465Completed389Est. Mar 2014
Pfizer
PfizerNEW YORK, NY
1 program
1
1
GabapentinPhase 31 trial
Active Trials
NCT01052896Withdrawn0Est. Aug 2012
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
Qizhiweitong granulePhase 41 trial
Active Trials
NCT02460601Completed400Est. Oct 2015
Zeria Pharmaceutical
4 programs
2
2
Acotiamide hydrochloride hydratePhase 31 trial
Z-338Phase 31 trial
Z-338Phase 21 trial
Z-338Phase 21 trial
Active Trials
NCT00333372Completed440
NCT00323817Completed282Est. Oct 2009
NCT04526119Active Not Recruiting55Est. Jun 2026
+1 more trials
Abbott
AbbottABBOTT PARK, IL
2 programs
1
1
Itopride Hydrochloride 150 mg extended release tabletsPhase 31 trial
ItopridePhase 2/31 trial
Active Trials
NCT00272103Completed500Est. Jan 2002
NCT06217393Completed564Est. Feb 2025
Ildong Pharmaceutical
1 program
1
Motireb 5/100 mgPhase 31 trial
Active Trials
NCT02831543Unknown354Est. Jun 2017
Astellas
AstellasChina - Shenyang
1 program
1
YM443Phase 11 trial
Active Trials
NCT00850746Completed80Est. Apr 2009
Hamilton medical
Hamilton medicalSwitzerland - Bonaduz
1 program
Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients PresentingN/A1 trial
Active Trials
NCT03868267Unknown1,500Est. Dec 2023
Nordic Pharma
Nordic PharmaFrance - Paris
1 program
LactobacillusN/A1 trial
Active Trials
NCT07276009Not Yet Recruiting60Est. May 2026
Biocodex
BiocodexFrance - Gentilly
1 program
Symbiosys® StomalexN/A1 trial
Active Trials
NCT07212907Recruiting198Est. Jan 2027
Eisai
EisaiChina - Liaoning
1 program
RabeprazolePHASE_2Small Molecule1 trial
Active Trials
NCT01089543Completed338Est. Aug 2011

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
UNION therapeuticsQizhiweitong granule
Dong-A STMotilitone ®
AbbottItopride Hydrochloride 150 mg extended release tablets
Dong-A STDA-5212
Zeria PharmaceuticalAcotiamide hydrochloride hydrate
Ildong PharmaceuticalMotireb 5/100 mg
PfizerGabapentin
Zeria PharmaceuticalZ-338
AbbottItopride
EisaiRabeprazole
Zeria PharmaceuticalZ-338
Zeria PharmaceuticalZ-338
AstellasYM443
Nordic PharmaLactobacillus
BiocodexSymbiosys® Stomalex

Showing 15 of 17 trials with date data

Clinical Trials (17)

Total enrollment: 6,456 patients across 17 trials

NCT02460601UNION therapeuticsQizhiweitong granule

The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study

Start: Dec 2013Est. completion: Oct 2015400 patients
Phase 4Completed
NCT01817465Dong-A STMotilitone ®

A Study to Demonstrate the Efficacy and Safety of Motilitone®

Start: Aug 2012Est. completion: Mar 2014389 patients
Phase 4Completed
NCT06217393AbbottItopride Hydrochloride 150 mg extended release tablets

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia

Start: Feb 2024Est. completion: Feb 2025564 patients
Phase 3Completed
NCT05842408Dong-A STDA-5212

Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

Start: Jun 2023Est. completion: Sep 2024384 patients
Phase 3Completed
NCT04526119Zeria PharmaceuticalAcotiamide hydrochloride hydrate

A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia

Start: Feb 2021Est. completion: Jun 202655 patients
Phase 3Active Not Recruiting
NCT02831543Ildong PharmaceuticalMotireb 5/100 mg

Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.

Start: Apr 2016Est. completion: Jun 2017354 patients
Phase 3Unknown
NCT01052896PfizerGabapentin

Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition

Start: Mar 2010Est. completion: Aug 20120
Phase 3Withdrawn
NCT00761358Zeria PharmaceuticalZ-338

To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia

Start: Sep 2008Est. completion: Aug 2010820 patients
Phase 3Completed
NCT00272103AbbottItopride

Itopride in Functional Dyspepsia:a Dose Finding Study

Start: Dec 2000Est. completion: Jan 2002500 patients
Phase 2/3Completed
NCT01089543EisaiRabeprazole

A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)

Start: Apr 2010Est. completion: Aug 2011338 patients
Phase 2Completed
NCT00333372Zeria PharmaceuticalZ-338

To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia

Start: Apr 2006440 patients
Phase 2Completed
NCT00323817Zeria PharmaceuticalZ-338

To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

Start: Apr 2006Est. completion: Oct 2009282 patients
Phase 2Completed
NCT00850746AstellasYM443

A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults

Start: Feb 2009Est. completion: Apr 200980 patients
Phase 1Completed
NCT07276009Nordic PharmaLactobacillus

Probiotics in Functional Dyspepsia

Start: Jan 2026Est. completion: May 202660 patients
N/ANot Yet Recruiting
NCT07212907BiocodexSymbiosys® Stomalex

Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)

Start: Dec 2025Est. completion: Jan 2027198 patients
N/ARecruiting
NCT07096921Dong-A STMosapride citrate 5 mg + DA-9701 30 mg

The Effect of Two Prokinetics in Patients With Functional Dyspepsia

Start: Jul 2025Est. completion: Mar 202692 patients
N/AActive Not Recruiting
NCT03868267Hamilton medicalJapanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

Start: May 2019Est. completion: Dec 20231,500 patients
N/AUnknown

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

6 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 6,456 patients
14 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.