MOVANTIK (naloxegol oxalate)
Movantik treats opioid-induced constipation in adults who are managing chronic pain not caused by active cancer. It helps patients who experience digestive issues due to their pain medication, including those with long-term pain resulting from previous cancer or its treatment. This medication is used for individuals who have a stable pain management plan and do not need frequent increases in their opioid dose.
How MOVANTIK Works
This medication works by blocking mu-opioid receptors in the gastrointestinal tract to counteract the slowing effects of opioids on the bowels. Because the drug is designed to stay out of the central nervous system, it can improve digestive function without affecting the pain-relieving benefits of the patient's opioid therapy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-09-16
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
MOVANTIK Approval History
What MOVANTIK Treats
2 indicationsMOVANTIK is approved for 2 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid-Induced Constipation
- Chronic Non-Cancer Pain
MOVANTIK 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 MOVANTIK
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03060512 results posted | D3820L00017 | Ph 4 | completed | To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation |
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.
MOVANTIK FDA Label Details
Indications & Usage
FDA Label (PDF)MOVANTIK is indicated for the treatment of Opioid-Induced Constipation; Chronic Non-Cancer Pain.
Pro Intelligence Preview
Deep insights for MOVANTIK
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 8 active patents
Trial Analysis
- • 13 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