Drug

Eluxadoline

Approved medicine

ClassMu opioid receptor agonistResearchOngoing clinical research

Also known as Viberzi.

RxNorm1653781 ChEMBLCHEMBL2159122 ATCA07DA06UNII45TPJ4MBQ1

Active clinical trials

Mu-type opioid receptor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Clinical trial2025-09-19Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Clinical trial2025-07-17Results expected Q4 2032 · ClinicalTrials.gov

Double Blind, Placebo Controlled, Cross Over Study to Investigate the Effectiveness and Safety of Eluxadoline in the Treatment of Diabetic Diarrhea

Clinical trial2024-12-01Withdrawn · ClinicalTrials.gov

3030-401-002: An Open-Label Pilot Study of Eluxadoline in Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) Who Have Evidence of Bile Acid Malabsorption (BAM)

Clinical trial2021-05-19Results posted · ClinicalTrials.gov

Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline

Clinical trial2020-03-01Withdrawn · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea

Clinical trial2019-10-22Results posted · ClinicalTrials.gov

A Phase 4 Multicenter, Multinational, Prospective, Randomized, Placebo-Controlled, Double-Blinded Parallel Group Study to Assess Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms With Prior Loperamide Use (RELIEF)

Clinical trial2019-02-15Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Clinical trial2018-09-04Results posted · ClinicalTrials.gov

Clinical trial2018-07-30Results posted · ClinicalTrials.gov

Drug Safety Update: Eluxadoline (Truberzi▼): risk of pancreatitis; do not use in patients who have undergone cholecystectomy or in those with biliary disorders

Regulatory2017-12-14MHRA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Eluxadoline

Aliases & brands

Viberzi

RxNorm CUI

1653781

ChEMBL ID

CHEMBL2159122

ATC codes

A07DA06

UNII

45TPJ4MBQ1

Primary mechanism

Mu opioid receptor agonist

Regulatory jurisdictions

mhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Mu-type opioid receptor

OPRM1 · P35372

AGONISTMu opioid receptor agonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

MHRA

Total events

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2017-12-14Safety communicationSafety

Drug Safety Update: Eluxadoline (Truberzi▼): risk of pancreatitis; do not use in patients who have undergone cholecystectomy or in those with biliary disorders

Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

9 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2020

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 9

Phase 23Phase 2 / 31Phase 33Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

3030-401-002: An Open-Label Pilot Study of Eluxadoline in Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) Who Have Evidence of Bile Acid Malabsorption (BAM)

CompletedPH IVAllergann=242020

CompletedPH IVAllergann=3462018

A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Enrolling by invitationPH IIIAbbVien=1242032

Double Blind, Placebo Controlled, Cross Over Study to Investigate the Effectiveness and Safety of Eluxadoline in the Treatment of Diabetic Diarrhea

WithdrawnPH II/IIITemple University2024

CompletedPH IIIKey trialFuriex Pharmaceuticals, Incn=1,2822014

Recent completions

Trials that read out recently, adding to the completed evidence base.

3030-401-002: An Open-Label Pilot Study of Eluxadoline in Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) Who Have Evidence of Bile Acid Malabsorption (BAM)

CompletedPH IVAllergann=242020

CompletedPH IVAllergann=3462018

CompletedPH IIIKey trialFuriex Pharmaceuticals, Incn=1,2822014

CompletedPH IIIKey trialFuriex Pharmaceuticals, Incn=1,1462014

CompletedPH IIFuriex Pharmaceuticals, Incn=8072011

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.