METHYLNALTREXONE BROMIDE · Teva
METHYLNALTREXONE BROMIDE is FDA-approved to treat 3 conditions (same as RELISTOR).
Details
- Status
- Prescription
- First Approved
- 2008-04-24
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
METHYLNALTREXONE BROMIDE Approval History
What METHYLNALTREXONE BROMIDE Treats
3 indicationsMETHYLNALTREXONE BROMIDE is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid-Induced Constipation
- Chronic Non-Cancer Pain
- Active Cancer
Same approved indications as RELISTOR (same active ingredient).
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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| NCT04083651 | SAL-REL-2042 | Ph 2, Ph 3 | withdrawn | A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer |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.
METHYLNALTREXONE BROMIDE FDA Label Details
Indications & Usage
METHYLNALTREXONE BROMIDE is FDA-approved to treat 3 conditions — same approved indications as RELISTOR.
Looking for the branded version?
RELISTOR
Full clinical data, patents, trials, and competitive landscape for methylnaltrexone bromide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.