ALVIMOPAN
Alvimopan is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. It is used to manage postoperative ileus, a multifactorial impairment of gastrointestinal motility that commonly follows abdominal surgery. By accelerating the return of normal bowel function, alvimopan can help reduce the duration of hospital stays.
How ALVIMOPAN Works
Alvimopan is a selective, peripherally acting µ-opioid receptor antagonist (PAMORA). It competitively binds to µ-opioid receptors in the gastrointestinal tract, blocking the inhibitory effects of both endogenous opioids released during surgical stress and exogenous opioid analgesics. Because its ability to cross the blood-brain barrier is highly limited at therapeutic doses, alvimopan antagonizes the peripheral effects of opioids on gut motility without reversing their central analgesic effects. This helps maintain gastrointestinal contractility and speeds recovery of the digestive system.
Details
- Status
- Prescription
- First Approved
- 2019-12-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ALVIMOPAN Approval History
What ALVIMOPAN Treats
1 indicationsALVIMOPAN is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastrointestinal Recovery
ALVIMOPAN Boxed Warning
POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with alvimopan, no increased risk of myocardial infarction was observed [see Warnings and Precautions ( 5.1 )] . Because of the potential risk of myocardial infarction with long...
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with alvimopan, no increased risk of myocardial infarction was observed [see Warnings and Precautions ( 5.1 )] . Because of the potential risk of myocardial infarction with long-term use, alvimopan is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the Alvimopan REMS Program [see Warnings and Precautions ( 5.1 , 5.2 )] . WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY See full prescribing information for complete boxed warning. Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. ( 5.1 ) Alvimopan capsules are available only through a restricted program for short-term use (15 doses) called the Alvimopan REMS Program. ( 5.1 , 5.2 )
ALVIMOPAN 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?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
10 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 |
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.
ALVIMOPAN FDA Label Details
Indications & Usage
ALVIMOPAN is indicated for the treatment of Gastrointestinal Recovery.
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been es...
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Full clinical data, patents, trials, and competitive landscape for alvimopan.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.