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Viberzi (ELUXADOLINE)
Viberzi works by activating the mu-opioid receptor in the gut to slow down bowel movements and reduce diarrhea.
At a glance
| Generic name | ELUXADOLINE |
|---|---|
| Sponsor | AbbVie |
| Drug class | mu-Opioid Receptor Agonist [EPC] |
| Target | Mu-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Eluxadoline is mu-opioid receptor agonist; eluxadoline is also delta opioid receptor antagonist and kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively. The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined; however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM. In animals, eluxadoline interacts with opioid receptors in the gut.
Approved indications
- Irritable bowel syndrome with diarrhea
Common side effects
- Constipation
- Nausea
- Abdominal Pain
- Upper Respiratory Tract Infection
- Vomiting
- Nasopharyngitis
- Abdominal Distention
- Bronchitis
- Dizziness
- Flatulence
- Rash
- Increased ALT
Key clinical trials
- Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children (PHASE2)
- A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) (PHASE3)
- Investigation of Eluxadoline for Diabetic Diarrhea (PHASE2,PHASE3)
- Eluxadoline Bile Acid Malabsorption (BAM) Study (PHASE4)
- Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea (PHASE2)
- Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence (PHASE2)
- Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use (PHASE4)
- Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Viberzi CI brief — competitive landscape report
- Viberzi updates RSS · CI watch RSS
- AbbVie portfolio CI