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Eluxadoline

Phase 3

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |AbbVie Inc.|Last Updated: Sep 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment219
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04880876A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)PHASE3 ENROLLING BY_INVITATION 124 — — Aug 13, 2021Dec 1, 2032Jul 17, 20256 United States
NCT03339128Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in ChildrenPHASE2 RECRUITING 95 — — Nov 15, 2017Dec 1, 2026Sep 19, 202546 United States, Bulgaria +7
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Study Endpoints
Primary Endpoints
Percentage of Participants with Adverse Events
52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
52 weeks
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Baseline (2 Weeks prior to randomization) to Week 4

Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

Secondary Endpoints
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
Baseline (2 Weeks prior to randomization) to Week 4
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open Label 6-11 years of age: Eluxadoline 50mgEXPERIMENTALEluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day.
Open Label 12-17 years of age: Eluxadoline 100 mgEXPERIMENTALEluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day.
Double Blind 6-11 years of age: Eluxadoline 25mgEXPERIMENTALBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Double Blind 6-11 years of age: Eluxadoline 50mgEXPERIMENTALBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Double Blind 12-17 years of age: Eluxadoline 25mgEXPERIMENTALBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Double Blind 12-17 years of age: Eluxadoline 50mgEXPERIMENTALBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Double Blind 12-17 years of age: Eluxadoline 100mgEXPERIMENTALBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID
Eluxadoline 25mgEXPERIMENTALEluxadoline 25mg, oral administration, twice daily
Eluxadoline 50mgEXPERIMENTALEluxadoline 50mg, oral administration, twice daily
Eluxadoline 100mgEXPERIMENTALEluxadoline 100mg, oral administration, twice daily
PlaceboEXPERIMENTALDose-matched placebo, oral administration, twice daily
Interventions
NameTypeDescription
25mg EluxadolineDRUGOral Tablets
100mg EluxadolineDRUGOral Tablets
EluxadolineDRUGOral tablets
PlaceboDRUGOral tablets
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: Inclusion Criteria: * Male or female participants must be 6 to 17 years of age (inclusive) * Participants must have completed study intervention in their lead-in study Exclusion Criteria: * Participant has an unresolved AE or a clinically significant finding on a physical exa...

Countries:United StatesBulgariaCanadaGermanyHungaryNetherlandsPolandSpainUnited Kingdom
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Competitive Landscape -Irritable Bowel Syndrome 13 trials
CompanyTickerTrialsLead PhaseDrugs
Ardelyx, Inc.ARDX4PHASE3Tenapanor
AbbVie, Inc.ABBV2PHASE3Eluxadoline
Disc Medicine, Inc.IRON1PHASE2DISC-0974
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2 — Undisclosed
Johnson & JohnsonJNJ1 — Anti TNF therapy including infliximab, No Biologics
Cooper Companies, Inc.COO1NAUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03339128primaryCompletionDate: changed
LOWMay 26, 2026NCT04880876primaryCompletionDate: changed
LOWMay 24, 2026NCT03339128studyFirstPostDate: changed
LOWMay 24, 2026NCT04880876studyFirstPostDate: changed