ELUXADOLINE · MSN PHARMACEUTICALS INC
ELUXADOLINE is FDA-approved to treat 1 condition (same as VIBERZI).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-05-27
- Routes
- ORAL
- Dosage Forms
- TABLET
ELUXADOLINE Approval History
What ELUXADOLINE Treats
1 indicationsELUXADOLINE is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome with Diarrhea
Same approved indications as VIBERZI (same active ingredient).
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.
ELUXADOLINE FDA Label Details
Indications & Usage
ELUXADOLINE is FDA-approved to treat 1 condition — same approved indications as VIBERZI.
Looking for the branded version?
VIBERZI
Full clinical data, patents, trials, and competitive landscape for eluxadoline.
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