RELISTOR (methylnaltrexone bromide)
RELISTOR is indicated for the treatment of Opioid-Induced Constipation; Chronic Non-Cancer Pain; Active Cancer.
How RELISTOR Works
Methylnaltrexone is a selective antagonist of opioid binding at the mu-opioid receptor. As a quaternary amine, its ability to cross the blood-brain barrier is restricted. This allows the medication to function as a peripherally-acting mu-opioid receptor antagonist (PAMORA) in tissues such as the gastrointestinal tract, decreasing the constipating effects of opioids without reversing their analgesic effects in the central nervous system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-04-24
- Patent Cliff
- 2031
- Routes
- ORAL, SUBCUTANEOUS
- Dosage Forms
- TABLET, SOLUTION
RELISTOR Approval History
What RELISTOR Treats
3 indicationsRELISTOR is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid-Induced Constipation
- Chronic Non-Cancer Pain
- Active Cancer
RELISTOR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 RELISTOR
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04083651 | SAL-REL-2042 | Ph 2, Ph 3 | withdrawn | A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer |
| NCT01366326 | MNTX 1109 | Ph 1 | completed | Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects |
| NCT00672139 results posted | 3200K1-4001 B2541006 | Ph 4 | completed | Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness |
| NCT01004393 results posted | VCC 0911 VCC 0911 | Ph 2 | completed | Methylnaltrexone for Opioid-induced Constipation in Cancer Patients |
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.
RELISTOR FDA Label Details
Indications & Usage
FDA Label (PDF)RELISTOR is indicated for the treatment of Opioid-Induced Constipation; Chronic Non-Cancer Pain; Active Cancer.
RELISTOR Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for RELISTOR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 72 active patents
Trial Analysis
- • 4 total trials
- • Stage: Declining
Competitive Landscape
- • 4 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