Skip to main content

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 41 trial
Effectiveness of Rotavirus Immunization in NicaraguaN/A1 trial
Active Trials
NCT01133808Completed667Est. Jan 2011
NCT01960725Completed66Est. May 2016
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 31 trial
Active Trials
NCT03130114Completed8,268Est. Jan 2020
PATH Biotech
2 programs
1
1
ROTAVAC®Phase 2/3
Oral Rotavirus Vaccine 116E Live AttenuatedPhase 1/2Vaccine
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
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
NCT05933525Completed60Est. 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_4
Active Trials
NCT00097422CompletedEst. Apr 2005
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/A1 trial
Active Trials
NCT04826991Active Not Recruiting908Est. Aug 2027
Temple Therapeutics
Temple TherapeuticsNetherlands - Geleen
1 program
Active UV DeviceN/A
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
MSDRV5
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
Alliance Pharmaceuticalssulfasalazine

Showing 15 of 46 trials with date data

Clinical Trials (50)

Total enrollment: 31,977 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

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 IMM-124E (Travelan®) in a Controlled Human Infection Model

Start: May 2023Est. completion: Dec 202460 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 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

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
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

Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation

Start: Sep 2015Est. completion: Jul 20173,433 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 31,977 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.