VIBERZI (eluxadoline)
Viberzi treats adults who have irritable bowel syndrome with diarrhea. It is used to help manage the symptoms of this condition by interacting with receptors located in the digestive system. This medication provides a targeted approach for patients needing relief from the frequent diarrhea associated with IBS.
How VIBERZI Works
This medication works by targeting three specific types of opioid receptors in the gut. It acts as an agonist for the mu and kappa receptors and as an antagonist for the delta receptors. These combined actions on the receptors in the digestive tract help regulate bowel function.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-05-27
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
VIBERZI Approval History
What VIBERZI Treats
1 indicationsVIBERZI is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome with Diarrhea
VIBERZI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VIBERZI
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03339128 | 3030-202-002 2017-003770-14 | Ph 2 | recruiting | Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children |
| NCT03441581 results posted | 3030-401-002 | Ph 4 | completed | Eluxadoline Bile Acid Malabsorption (BAM) Study |
| NCT01130272 results posted | 27018966IBS2001 | Ph 2 | completed | Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea |
| NCT02959983 results posted | CMO-US-GI-0429 | Ph 4 | completed | Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use |
| NCT01553591 results posted | 27018966IBS3001 2012-001600-38 | Ph 3 | completed | Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) |
| NCT01553747 results posted | 27018966IBS3002 2012-001601-24 | Ph 3 | completed | Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIBERZI FDA Label Details
Indications & Usage
FDA Label (PDF)VIBERZI is indicated for the treatment of Irritable Bowel Syndrome with Diarrhea.
VIBERZI Patents & Exclusivity
Patents (14 active)
Pro Intelligence Preview
Deep insights for VIBERZI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 56 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment