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Diarrhea

27
Pipeline Programs
30
Companies
50
Clinical Trials
4 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
2
5
2
12
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
450%
Vaccine
338%
Small Molecule
113%
+ 41 programs with unclassified modality

On Market (2)

Approved therapies currently available

Bausch Health
XIFAXANApproved
rifaximin
Bausch Health
oral2010
1.1B Part D
Bausch Health
RIFAXIMINApproved
rifaximin
Bausch Health
oral

Competitive Landscape

30 companies ranked by most advanced pipeline stage

MSD
MSDIreland - Ballydine
2 programs
1
RV5Phase 4
Effectiveness of Rotavirus Immunization in NicaraguaN/A
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
2 programs
1
RV5Phase 4
Effectiveness of Rotavirus Immunization in NicaraguaN/A
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
1
XIFAXAN(rifaximin)Phase 45 trials
Active Trials
NCT07285785Recruiting54Est. Jul 2027
NCT06312683Recruiting16Est. Jul 2026
NCT03856359Completed10Est. Nov 2020
+2 more trials
Human BioSciences
Human BioSciencesWV - Martinsburg
4 programs
3
ETEC/rCTB vaccinePhase 3Vaccine1 trial
LactoferrinPhase 31 trial
bovine lactoferrinPhase 31 trial
MNPN/A1 trial
Active Trials
NCT02428647Completed3,433Est. Jul 2017
NCT02556996Completed356Est. Apr 2002
NCT05519254Recruiting600Est. Dec 2026
+1 more trials
Public Health Vaccines
2 programs
1
1
AzithromycinPhase 3
ACE527Phase 21 trial
Active Trials
NCT01060748Completed70Est. Oct 2010
Ferrer
FerrerSpain - Barcelona
2 programs
2
Gelatin tannatePhase 31 trial
RacecadotrilPhase 31 trial
Active Trials
NCT04065529Completed150Est. Jun 2020
NCT01153854Completed454Est. Dec 2009
Biocorp
BiocorpFrance - Issoire
2 programs
2
Lactobacillus acidophilus CL1285 and Lactobacillus caseiPhase 31 trial
Probiotic: Bio-K+ CL1285Phase 31 trial
Active Trials
NCT00328263Completed472Est. Oct 2007
NCT00737412Completed277Est. Jan 2010
Alliance Pharmaceuticals
2 programs
2
probioticPhase 32 trials
sulfasalazinePhase 31 trial
Active Trials
NCT01473290Withdrawn0
NCT07144826Recruiting161Est. Jul 2027
NCT01198145Completed87Est. Jul 2017
Abbott
AbbottABBOTT PARK, IL
1 program
1
Racecadotril plus ORSPhase 31 trial
Active Trials
NCT03463512Completed124Est. Sep 2018
Allied Medical
Allied MedicalMO - St. Louis
1 program
1
azithromycinPhase 32 trials
Active Trials
NCT03130114Completed8,268Est. Jan 2020
NCT02344628Completed583Est. Dec 2016
Bharat Biotech
Bharat BiotechIndia - Hyderabad
2 programs
1
1
ROTAVAC®Phase 2/31 trial
Oral Rotavirus Vaccine 116E Live AttenuatedPhase 1/2Vaccine1 trial
Active Trials
NCT00439660Completed540Est. Nov 2008
NCT03602053Completed450Est. Oct 2019
PATH Biotech
2 programs
1
1
ROTAVAC®Phase 2/3
Oral Rotavirus Vaccine 116E Live AttenuatedPhase 1/2Vaccine
United BioPharma
United BioPharmaTaiwan - Hsinchu
1 program
1
E. coli ETVAXPhase 21 trial
Active Trials
NCT03729219Completed749Est. Apr 2019
Helsinn
HelsinnIreland - Dublin
1 program
1
ElsiglutidePhase 2Peptide1 trial
Active Trials
NCT01543451Completed138Est. Oct 2013
Biocodex
BiocodexFrance - Gentilly
1 program
1
Saccharomyces boulardiiPhase 21 trial
Active Trials
NCT00002088Completed100
Immuron
ImmuronAustralia - Blackburn North
1 program
1
TravelanPhase 21 trial
Active Trials
NCT05933525Completed63Est. Dec 2024
Ache Laboratorios Farmaceuticos
1 program
1
ACH04Phase 11 trial
Active Trials
NCT02949089Completed60Est. Sep 2014
Sandoz
SandozAustria - Kundl
2 programs
OctreotideN/APeptide1 trial
OctreotideN/APeptide1 trial
Active Trials
NCT00002252Completed
NCT00002253Completed
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
2 programs
PTM202N/A1 trial
Standard MNPN/A1 trial
Active Trials
NCT02385773Completed321Est. Jul 2016
NCT03406793Completed2,886Est. Jan 2020
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
2 programs
Peer-support for exclusive breastfeedingN/A1 trial
Solar disinfection in transparent containersN/A1 trial
Active Trials
NCT00397150Completed2,579Est. Apr 2011
NCT01082107Completed800Est. Aug 2009
Sanofi
SanofiPARIS, France
2 programs
0.9% Normal SalinePHASE_21 trial
Spores of Bacillus Clausii Probiotic StrainPHASE_31 trial
Active Trials
NCT00772343Completed116Est. Jun 2012
NCT00265369Completed420
Merck & Co.
Merck & Co.RAHWAY, NJ
2 programs
OPT-80PHASE_21 trial
RV5PHASE_41 trial
Active Trials
NCT00097422CompletedEst. Apr 2005
NCT01960725Completed66Est. May 2016
Ipsen
IpsenChina - Tianjin
2 programs
lanreotidePHASE_2_3Peptide1 trial
DiosmectitePHASE_41 trial
Active Trials
NCT00891371Completed42Est. Aug 2013
NCT00276328Completed346Est. Jul 2006
Plus Therapeutics
2 programs
Lactobacillus acidophilus CL1285 and Lactobacillus caseiPHASE_3
Probiotic: Bio-K+ CL1285PHASE_3
Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
Loperamide/simeticone 2 mg/125 mg capletsPHASE_41 trial
loperamide-simethiconePHASE_41 trial
Active Trials
NCT00807326Completed415Est. Nov 2009
NCT00685607Completed45Est. Oct 2008
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Active UV DeviceN/A
Temple Therapeutics
Temple TherapeuticsNetherlands - Geleen
1 program
Active UV DeviceN/A1 trial
Active Trials
NCT04826991Active Not Recruiting908Est. Aug 2027
Steel Therapeutics
Steel TherapeuticsIA - Iowa City
1 program
Epidemiological Study of Colorectal Cancer in WuHanN/A1 trial
Active Trials
NCT01863303Unknown1Est. Jun 2018
Splash Pharmaceuticals
1 program
Splash WASH in Schools programmeN/A1 trial
Active Trials
NCT05024890Completed7,072Est. Aug 2022
Pfizer
PfizerNEW YORK, NY
1 program
TigecyclineN/ASmall Molecule1 trial
Active Trials
NCT01401023Completed10Est. Jul 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Bausch Healthrifaximin
Bausch Healthrifaximin
Bausch Healthrifaximin
Merck & Co.RV5
Bausch Healthrifaximin
Bausch Healthrifaximin
Johnson & JohnsonLoperamide/simeticone 2 mg/125 mg caplets
Johnson & Johnsonloperamide-simethicone
IpsenDiosmectite
Bausch Healthrifaximin
Human BioSciencesLactoferrin
FerrerGelatin tannate
AbbottRacecadotril plus ORS
Allied Medicalazithromycin
Allied Medicalazithromycin

Showing 15 of 46 trials with date data

Clinical Trials (50)

Total enrollment: 29,130 patients across 50 trials

Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea

Start: Feb 2026Est. completion: Jul 202754 patients
Phase 4Recruiting

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Start: Jul 2024Est. completion: Jul 202616 patients
Phase 4Recruiting

Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects

Start: Jan 2019Est. completion: Feb 20205 patients
Phase 4Terminated

An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

Start: Feb 2014Est. completion: May 201666 patients
Phase 4Completed

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Start: Jan 2013Est. completion: Dec 2014222 patients
Phase 4Completed

Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease

Start: Oct 2012Est. completion: Sep 20150
Phase 4Withdrawn
NCT00807326Johnson & JohnsonLoperamide/simeticone 2 mg/125 mg caplets

A Comparison of Three Medications to Treat Diarrhea in Adults.

Start: Nov 2008Est. completion: Nov 2009415 patients
Phase 4Completed
NCT00685607Johnson & Johnsonloperamide-simethicone

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea

Start: Oct 2008Est. completion: Oct 200845 patients
Phase 4Completed
NCT00276328IpsenDiosmectite

Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults

Start: Jan 2005Est. completion: Jul 2006346 patients
Phase 4Completed

Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea

Start: Jun 2004Est. completion: Aug 2005316 patients
Phase 4Completed

Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy

0
Phase 3Withdrawn

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Start: Mar 2023Est. completion: Dec 2026600 patients
Phase 3Recruiting
NCT04065529FerrerGelatin tannate

Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in the Treatment of Acute Diarrhea (INDIGO)

Start: Sep 2019Est. completion: Jun 2020150 patients
Phase 3Completed
NCT03463512AbbottRacecadotril plus ORS

Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

Start: Mar 2018Est. completion: Sep 2018124 patients
Phase 3Completed

Antibiotics for Children With Severe Diarrhoea

Start: May 2017Est. completion: Jan 20208,268 patients
Phase 3Completed

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Start: Jun 2015Est. completion: Dec 2016583 patients
Phase 3Completed

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Start: Apr 2011Est. completion: Jul 201787 patients
Phase 3Completed
NCT00737412BiocorpProbiotic: Bio-K+ CL1285

Efficacy of BIO-K+ CL1285® Prophylaxis in the Prevention of Traveler's Diarrhea in Adults

Start: Apr 2008Est. completion: Jan 2010277 patients
Phase 3Completed

Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

Start: Feb 2008Est. completion: Oct 2011555 patients
Phase 3Completed

Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy

Start: Mar 2007Est. completion: Dec 2010322 patients
Phase 3Completed
NCT01153854FerrerRacecadotril

Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico

Start: Jan 2007Est. completion: Dec 2009454 patients
Phase 3Completed
NCT00328263BiocorpLactobacillus acidophilus CL1285 and Lactobacillus casei

Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

Start: Mar 2006Est. completion: Oct 2007472 patients
Phase 3Completed

A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Start: Dec 2005Est. completion: Dec 2008237 patients
Phase 3Completed

Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.

Start: Dec 2005Est. completion: Sep 2008660 patients
Phase 3Completed
NCT00265369SanofiSpores of Bacillus Clausii Probiotic Strain

TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Start: May 2004420 patients
Phase 3Completed

Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children

Start: Oct 1998Est. completion: Apr 2002356 patients
Phase 3Completed

Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

Start: Jan 2019Est. completion: Oct 2019450 patients
Phase 2/3Completed

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Start: Jul 2009Est. completion: Aug 201342 patients
Phase 2/3Completed
NCT00002088BiocodexSaccharomyces boulardii

Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

100 patients
Phase 2Completed

Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model.

Start: May 2023Est. completion: Dec 202463 patients
Phase 2Completed

Trial of Rifaximin in Probable Alzheimer's Disease

Start: Apr 2019Est. completion: Nov 202010 patients
Phase 2Completed

Rifaximin on Visceral Hypersensitivity

Start: Jul 2018Est. completion: Nov 20214 patients
Phase 2Terminated

Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)

Start: Jun 2017Est. completion: Apr 2019749 patients
Phase 2Completed

Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea

Start: Feb 2012Est. completion: Oct 2013138 patients
Phase 2Completed

Safety and Efficacy Study of a Vaccine Against Enterotoxigenic Escherichia Coli (ETEC) to Prevent Moderate to Severe Diarrhea

Start: Mar 2010Est. completion: Oct 201070 patients
Phase 2Completed
NCT00772343Sanofi0.9% Normal Saline

Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

Start: Feb 2009Est. completion: Jun 2012116 patients
Phase 2Completed

The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy

Start: Dec 2005Est. completion: Dec 201250 patients
Phase 2Unknown

Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

Start: Dec 2005Est. completion: Sep 2008525 patients
Phase 2Completed

OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)

Start: Nov 2004Est. completion: Apr 2005
Phase 2Completed

Rifaximin for the Treatment of Irritable Bowel Syndrome

Start: Jul 2003Est. completion: Jan 200792 patients
Phase 2Completed

Study of Rifaximin in Minimal Hepatic Encephalopathy

Start: Feb 2010Est. completion: Dec 201220 patients
Phase 1/2Completed
NCT00439660Bharat BiotechOral Rotavirus Vaccine 116E Live Attenuated

Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old

Start: Dec 2006Est. completion: Nov 2008540 patients
Phase 1/2Completed

Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy

Start: Mar 2026Est. completion: Jul 2027161 patients
Phase 1Recruiting

ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

Start: Jan 2013Est. completion: Sep 201460 patients
Phase 1Completed

Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers

Start: Sep 2008Est. completion: Nov 200824 patients
Phase 1Completed

A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

N/ACompleted

A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea

N/ACompleted
NCT05024890Splash PharmaceuticalsSplash WASH in Schools programme

The Impact of a School-based WASH Intervention on Child Health and School Attendance in Addis Ababa, Ethiopia

Start: Nov 2021Est. completion: Aug 20227,072 patients
N/ACompleted

Wells and Enteric Disease Transmission

Start: Jul 2021Est. completion: Aug 2027908 patients
N/AActive Not Recruiting

Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth

Start: Feb 2018Est. completion: Jan 20202,886 patients
N/ACompleted

Phase Legend

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

Key Insights

12 late-stage (Phase 3) programs, potential near-term approvals
4 actively recruiting trials targeting 29,130 patients
30 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.