TheraRadar
Data updated: May 26, 2026

METHYLNALTREXONE BROMIDE

Gastrointestinal Approved 2024-08-26
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2024-08-26
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Teva US GENERICS, STERILES Viatris
Active Ingredient: METHYLNALTREXONE BROMIDE

METHYLNALTREXONE BROMIDE Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2025
May 2025 ORIGINAL
Update
FDA Letter
Aug 2024 ORIGINAL
Update

What METHYLNALTREXONE BROMIDE Treats

2 FDA approvals

Originally approved for its first indication in 2024 . Covers 2 distinct patient populations.

  • Other (2)
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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NCT04083651 SAL-REL-2042 Ph 2, Ph 3 withdrawn A Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Looking for the branded version?

RELISTOR

Full clinical data, patents, trials, and competitive landscape for methylnaltrexone bromide.

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Data Sources

FDA Approval: ANDA208112 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.