ENTEREG (alvimopan)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2008-05-20
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ENTEREG Approval History
What ENTEREG Treats
2 FDA approvalsOriginally approved for its first indication in 2008 . Covers 2 distinct patient populations.
- Other (2)
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06703476 | 24-361 | Ph 3 | recruiting | A Study of Surgical Techniques During Cystectomy |
| NCT04405037 results posted | 20-321 | Ph 4 | completed | Alvimopan as a Rescue Treatment of Postoperative Ileus |
| NCT03216525 | 2017P000330 | Ph 3 | recruiting | Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol |
| NCT02742181 results posted | 10-15-28 | Ph 3 | terminated | Alvimopan as Rescue in Post op Ileus |
| NCT03352414 ILEUS results posted | 171044 | Ph 2 | terminated | Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC |
| NCT02789111 results posted | 18781 | Ph 4 | completed | Trial of Alvimopan in Major Spine Surgery |
| NCT03068975 | 55238 | Ph 4 | terminated | Alvimopan Use in Polytraumatized Patients |
| NCT02785003 KCRS | PRO00027024 | Ph 4 | withdrawn | Ketamine in Colorectal Surgery |
| NCT01704651 results posted | 12-004082 | Ph 3 | completed | Accelerating Gastrointestinal Recovery |
| NCT00708201 results posted | 3753-002 14CL403 | Ph 4 | completed | A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy |
| NCT01258569 | JOHN002914HE | Ph 2 | completed | Entereg Laparoscopic Colon Resection Study |
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.
ENTEREG FDA Label Details
ENTEREG Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ENTEREG
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 1 active patents
Trial Analysis
- • 12 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • 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