TheraRadar
Data updated: May 26, 2026

ELUXADOLINE

Trial Activity: Declining 1 active trials
Gastrointestinal Approved 2025-03-14
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Furiex Pharmaceuticals, Inc conducting 3 trials (50%)
2 indications explored (Focused)
→ irritable bowel syndrome (4 trials)
→ irritable bowel syndrome with diarrhea (2 trials)
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2025-03-14
Routes
ORAL
Dosage Forms
TABLET

Companies

ZYDUS PHARMS ASCEND LABORATORIES, LTD MSN PHARMACEUTICALS INC
Active Ingredient: ELUXADOLINE

ELUXADOLINE Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Mar 2025 ORIGINAL
Update
FDA Letter

What ELUXADOLINE Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
📋

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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Looking for the branded version?

VIBERZI

Full clinical data, patents, trials, and competitive landscape for eluxadoline.

See VIBERZI

Data Sources

FDA Approval: ANDA213522 → Trials: ClinicalTrials.gov →

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