Diarrhea

17
Pipeline Programs
8
Companies
15
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
1
6
7
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
1100%
+ 14 programs with unclassified modality

On Market (2)

Approved therapies currently available

U
RIFAXIMINApproved
rifaximin
Unknown Company
oral
Bausch Health
XIFAXANApproved
rifaximin
Bausch Health
oral2010

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
4 programs
1
2
1
Rifaximin 200 mg TabletPhase 41 trial
RifaximinPhase 31 trial
RifaximinPhase 31 trial
rifaximinPhase 21 trial
Active Trials
NCT00098384CompletedEst. Sep 2003
NCT00742469CompletedEst. Apr 2007
NCT00328380CompletedEst. Sep 2008
+1 more trials
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
RV5Phase 41 trial
OPT-80Phase 21 trial
Active Trials
NCT00097422CompletedEst. Apr 2005
NCT01960725Completed66Est. May 2016
Ipsen
IpsenChina - Tianjin
2 programs
1
1
DiosmectitePhase 41 trial
lanreotidePhase 2/3Peptide1 trial
Active Trials
NCT00891371Completed42Est. Aug 2013
NCT00276328Completed346Est. Jul 2006
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
2
Loperamide/simeticone 2 mg/125 mg capletsPhase 41 trial
loperamide-simethiconePhase 41 trial
Active Trials
NCT00807326Completed415Est. Nov 2009
NCT00685607Completed45Est. Oct 2008
Sanofi
SanofiPARIS, France
2 programs
1
1
Spores of Bacillus Clausii Probiotic StrainPhase 31 trial
0.9% Normal SalinePhase 21 trial
Active Trials
NCT00772343Completed116Est. Jun 2012
NCT00265369Completed420
Plus Therapeutics
2 programs
2
Lactobacillus acidophilus CL1285 and Lactobacillus caseiPhase 31 trial
Probiotic: Bio-K+ CL1285Phase 31 trial
Active Trials
NCT00328263CompletedEst. Oct 2007
NCT00737412CompletedEst. Jan 2010
Abbott
AbbottABBOTT PARK, IL
1 program
1
Racecadotril plus ORSPhase 31 trial
Active Trials
NCT03463512Completed124Est. Sep 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Bausch HealthRifaximin 200 mg Tablet
Merck & Co.RV5
Johnson & JohnsonLoperamide/simeticone 2 mg/125 mg caplets
Johnson & Johnsonloperamide-simethicone
IpsenDiosmectite
AbbottRacecadotril plus ORS
Plus TherapeuticsProbiotic: Bio-K+ CL1285
Plus TherapeuticsLactobacillus acidophilus CL1285 and Lactobacillus casei
Bausch HealthRifaximin
Bausch HealthRifaximin
SanofiSpores of Bacillus Clausii Probiotic Strain
Ipsenlanreotide
Sanofi0.9% Normal Saline
Merck & Co.OPT-80
Bausch Healthrifaximin

Clinical Trials (15)

Total enrollment: 1,574 patients across 15 trials

NCT07285785Bausch HealthRifaximin 200 mg Tablet

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

Start: Dec 2025Est. completion: Jul 2027
Phase 4Not Yet Recruiting
NCT01960725Merck & Co.RV5

An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

Start: Feb 2014Est. completion: May 201666 patients
Phase 4Completed
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
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
NCT00737412Plus TherapeuticsProbiotic: Bio-K+ CL1285

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

Start: Apr 2008Est. completion: Jan 2010
Phase 3Completed
NCT00328263Plus TherapeuticsLactobacillus 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 2007
Phase 3Completed
NCT00328380Bausch HealthRifaximin

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

Start: Dec 2005Est. completion: Sep 2008
Phase 3Completed
NCT00742469Bausch HealthRifaximin

Rifaximin for Prevention of Travellers' Diarrhea

Start: Jun 2005Est. completion: Apr 2007
Phase 3Completed
NCT00265369SanofiSpores of Bacillus Clausii Probiotic Strain

TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Start: May 2004420 patients
Phase 3Completed
NCT00891371Ipsenlanreotide

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Start: Jul 2009Est. completion: Aug 201342 patients
Phase 2/3Completed
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
NCT00097422Merck & Co.OPT-80

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

Start: Nov 2004Est. completion: Apr 2005
Phase 2Completed
NCT00098384Bausch Healthrifaximin

Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea

Start: Jun 2003Est. completion: Sep 2003
Phase 2Completed

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
8 companies competing in this space