Eluxadoline

Generic Name: Eluxadoline

Brand Names: Viberzi

Drug Type: Small Molecule

Chemical Formula: C_₃₂H_₃₅N_₅O_₅

CAS Number: 864821-90-9

Unique Ingredient Identifier: 45TPJ4MBQ1

Background: Eluxadoline is a mixed mu-opioid receptor agonist, kappa-opioid receptor agonist, and a-delta opioid receptor antagonist indicated for use in diarrhea-predominant irritable bowel syndrome (IBS-D). The mu-, kappa-, and delta-opioid receptors mediate endogenous and exogenous opioid response in the central nervous system and peripherally in the gastrointestinal system. Agonism of peripheral mu-opioid receptors results in reduced colonic motility, while antagonism of central delta-opioid receptors results in improved analgesia, making eluxadoline usable for the symptoms of both pain and diarrhea characteristic of IBS-D.

Marketed under the tradename Viberzi (FDA), eluxadoline is an antimotility agent that decreases bowel contractions, inhibits colonic transit, and reduces ﬂuid/ion secretion resulting in improved symptoms of abdominal pain and reductions in the Bristol Stool Scale.

Indication: For the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Associated Conditions: Diarrhoea Predominant Irritable Bowel Syndrome

Clinical Trials

A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Phase 3

Conditions: Irritable Bowel Syndrome

Interventions: Drug: 25mg Eluxadoline
Drug: 100mg Eluxadoline

First Posted Date: 2021-05-11

Last Posted Date: 2024-06-18

Lead Sponsor: AbbVie

Target Recruit Count: 124

Registration Number: NCT04880876

Locations: 🇺🇸
Florida Research Center, Inc. /ID# 227597, Miami, Florida, United States
🇺🇸
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600, Stockbridge, Georgia, United States
🇺🇸
Preferred Primary Care Physicians, Inc. /ID# 227596, Pittsburgh, Pennsylvania, United States

and more 1 locations

Investigation of Eluxadoline for Diabetic Diarrhea

Phase 2

Withdrawn

Conditions: Diabetic Diarrhea
Diarrhea
Diabetes

Interventions: Drug: Eluxadoline 100 mg

First Posted Date: 2020-03-18

Last Posted Date: 2023-05-06

Lead Sponsor: Temple University

Registration Number: NCT04313088

Locations: 🇺🇸
Temple University Hospital, Philadelphia, Pennsylvania, United States

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

Phase 2

Withdrawn

Conditions: Fecal Incontinence
Diarrhea
Urge Incontinence
Accidental Bowel Leakage
Anal Incontinence

Interventions: Drug: Eluxadoline 100 mg
Other: Placebo

First Posted Date: 2018-04-05

Last Posted Date: 2019-07-25

Lead Sponsor: University of North Carolina, Chapel Hill

Registration Number: NCT03489265

Eluxadoline Bile Acid Malabsorption (BAM) Study

Phase 4

Completed

Conditions: Irritable Bowel Syndrome With Diarrhea

Interventions: Drug: Eluxadoline

First Posted Date: 2018-02-22

Last Posted Date: 2021-05-19

Lead Sponsor: Allergan

Target Recruit Count: 24

Registration Number: NCT03441581

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

Phase 2

Recruiting

Conditions: Irritable Bowel Syndrome

Interventions: Drug: Placebo
Drug: Eluxadoline

First Posted Date: 2017-11-13

Last Posted Date: 2025-04-10

Lead Sponsor: AbbVie

Target Recruit Count: 95

Registration Number: NCT03339128

Locations: 🇪🇸
Hospital Universitario Dr. Peset /ID# 236755, Valencia, Spain
🇺🇸
Duplicate_VVCRD Research /ID# 234606, Garden Grove, California, United States
🇺🇸
Frederick County Pediatrics /ID# 234519, New Market, Maryland, United States

and more 43 locations

Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

Phase 4

Completed

Conditions: Irritable Bowel Syndrome With Diarrhea

Interventions: Drug: Placebo
Drug: Eluxadoline

First Posted Date: 2016-11-09

Last Posted Date: 2019-02-15

Lead Sponsor: Allergan

Target Recruit Count: 346

Registration Number: NCT02959983

Locations: 🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States
🇺🇸
Gtc Research, Shawnee Mission, Kansas, United States
🇺🇸
Pharmax Research Clinic Inc., Miami, Florida, United States

and more 76 locations