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Fecal Incontinence

13
Pipeline Programs
14
Companies
22
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Cell Therapy
2100%
+ 23 programs with unclassified modality

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
4 programs
1
LoperamidePhase 31 trial
Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI TrialN/A1 trial
Behavioral Therapy Of Obstetric Sphincter TearsN/A1 trial
ES-130N/A1 trial
Active Trials
NCT00729144Completed133Est. Jul 2010
NCT01166399Completed362Est. Oct 2012
NCT03278613Completed166Est. Mar 2020
+1 more trials
Cook MyoSite
Cook MyoSitePA - Pittsburgh
2 programs
1
1
IltamiocelPhase 3Cell Therapy1 trial
IltamiocelPhase 1/2Cell Therapy1 trial
Active Trials
NCT01600755Completed53Est. Oct 2021
NCT05776277Active Not Recruiting200Est. Dec 2027
Innovacell
InnovacellAustria - Innsbruck
1 program
1
aSMDCPhase 31 trial
Active Trials
NCT04976153Recruiting290Est. Jul 2027
Carbon Medical Technologies
1 program
1
Durasphere FIPhase 2
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
Eluxadoline 100 mgPhase 21 trial
Active Trials
NCT03489265Withdrawn0Est. Mar 2020
Galderma
GaldermaTX - Dallas
3 programs
1
Anal injection of Nasha DxPhase 1/21 trial
NASHA/DxN/A1 trial
SolestaN/A1 trial
Active Trials
NCT00605826Completed206Est. Nov 2009
NCT01110681Completed115Est. Dec 2010
NCT01380132Completed35Est. May 2009
Norgine
NorgineAustria - Vienna
5 programs
5
NRL001Phase 11 trial
NRL001Phase 11 trial
NRL001Phase 11 trial
NRL001Phase 11 trial
NRL001Phase 11 trial
Active Trials
NCT01099683Completed26Est. Jul 2010
NCT00893607Completed24Est. Dec 2007
NCT00857467Completed36
+2 more trials
Biocorp
BiocorpFrance - Issoire
1 program
1
Bioengineered Internal Anal SphincterPhase 11 trial
Active Trials
NCT05616208Active Not Recruiting10Est. Jul 2027
Medtronic
MedtronicNJ - Phillipsburg
2 programs
Medtronic INTERSIM II - 3058N/A1 trial
Sacral Nerve StimulationN/A1 trial
Active Trials
NCT00913601Terminated29Est. Jul 2013
NCT01957969Completed234Est. Dec 2017
Axonics
AxonicsCA - Irvine
1 program
Axonics SNM System INS Model 5101N/A1 trial
Active Trials
NCT07499258Not Yet Recruiting55Est. Dec 2029
Coloplast
ColoplastAustralia - Mulgrave
1 program
Fecal Incontinence Management SystemN/A1 trial
Active Trials
NCT00556972Terminated4Est. Apr 2008
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
1 program
NASHA/DxN/A
Applied Medical
Applied MedicalCA - Rancho Santa Margarita
1 program
SphinkeeperN/A
Carbon Biosciences
Carbon BiosciencesMA - Waltham
1 program
Durasphere FIPHASE_21 trial
Active Trials
NCT00762047Terminated90Est. Jun 2009

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Cook MyoSiteIltamiocel
InnovacellaSMDC
Human BioSciencesLoperamide
AbbVieEluxadoline 100 mg
Carbon BiosciencesDurasphere FI
Cook MyoSiteIltamiocel
GaldermaAnal injection of Nasha Dx
BiocorpBioengineered Internal Anal Sphincter
NorgineNRL001
NorgineNRL001
NorgineNRL001
NorgineNRL001
NorgineNRL001
AxonicsAxonics SNM System INS Model 5101
Human BioSciencesES-130

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 2,430 patients across 22 trials

Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

Start: Mar 2024Est. completion: Dec 2027200 patients
Phase 3Active Not Recruiting

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Start: May 2022Est. completion: Jul 2027290 patients
Phase 3Recruiting

Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)

Start: Feb 2014Est. completion: May 2016300 patients
Phase 3Completed
NCT03489265AbbVieEluxadoline 100 mg

Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence

Start: Apr 2019Est. completion: Mar 20200
Phase 2Withdrawn

A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

Start: Jun 2004Est. completion: Jun 200990 patients
Phase 2Terminated

Autologous Cell Therapy for Treatment of Fecal Incontinence

Start: Mar 2013Est. completion: Oct 202153 patients
Phase 1/2Completed
NCT01380132GaldermaAnal injection of Nasha Dx

Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Start: Feb 2004Est. completion: May 200935 patients
Phase 1/2Completed
NCT05616208BiocorpBioengineered Internal Anal Sphincter

Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence

Start: Nov 2022Est. completion: Jul 202710 patients
Phase 1Active Not Recruiting

Effect of 7 Days of Dosing With a 10 mg Rectal Suppository of NRL001in Patients With Faecal Incontinence

Start: Aug 2010Est. completion: Dec 201114 patients
Phase 1Completed

Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects

Start: Apr 2010Est. completion: Jul 201026 patients
Phase 1Completed

Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days

Start: Mar 2010Est. completion: Jun 201048 patients
Phase 1Completed

Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.

Start: Feb 200936 patients
Phase 1Completed

Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

Start: Apr 2007Est. completion: Dec 200724 patients
Phase 1Completed
NCT07499258AxonicsAxonics SNM System INS Model 5101

Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

Start: May 2026Est. completion: Dec 202955 patients
N/ANot Yet Recruiting

Neuromodulation for Accidental Bowel Leakage

Start: Feb 2018Est. completion: Mar 2020166 patients
N/ACompleted
NCT01957969MedtronicSacral Nerve Stimulation

French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

Start: Sep 2013Est. completion: Dec 2017234 patients
N/ACompleted
NCT01166399Human BioSciencesBehavioral Therapy Of Obstetric Sphincter Tears

Behavioral Therapy Of Obstetric Sphincter Tears

Start: Jul 2010Est. completion: Oct 2012362 patients
N/ACompleted
NCT00913601MedtronicMedtronic INTERSIM II - 3058

Treatment of Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Stimulation Bilaterally?

Start: May 2009Est. completion: Jul 201329 patients
N/ATerminated
NCT00729144Human BioSciencesAdaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

Start: Jun 2008Est. completion: Jul 2010133 patients
N/ACompleted
NCT00556972ColoplastFecal Incontinence Management System

A Feasibility Study of a Fecal Incontinence Management System for Medical Use

Start: Jan 2008Est. completion: Apr 20084 patients
N/ATerminated

Study to Evaluate Solesta for Treatment of Fecal Incontinence

Start: Nov 2007Est. completion: Dec 2010115 patients
N/ACompleted

A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

Start: Sep 2006Est. completion: Nov 2009206 patients
N/ACompleted

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 2,430 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.