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Drug

Methylnaltrexone bromide

Approved · EMA

Late-stage development

Also known as Relistor.

1

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department

Clinical trial2024-09-19Results posted · ClinicalTrials.gov

An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer

Clinical trial2024-02-03Withdrawn · ClinicalTrials.gov

A Phase II/III Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer

Clinical trial2023-10-15Withdrawn · ClinicalTrials.gov

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

Clinical trial2019-09-04Results posted · ClinicalTrials.gov

Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

Clinical trial2018-03-07Results posted · ClinicalTrials.gov

Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients

Clinical trial2016-02-02Results posted · ClinicalTrials.gov

The Effect of Naloxone and Mehtylnaltrexone on Esophageal Sensitivity in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled Study

Clinical trial2014-01-01Completed · ClinicalTrials.gov

Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

Clinical trial2011-12-01Withdrawn · ClinicalTrials.gov

Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit

Clinical trial2010-10-01Primary completion · ClinicalTrials.gov

A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects

Clinical trial2010-08-01Completed · ClinicalTrials.gov

Approval: Relistor (EMA)

Regulatory2008-07-01EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Methylnaltrexone bromide

Aliases & brands

Relistor

RxNorm CUI

979111

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2008-07-01

Latest approval

2008-07-01

Authorities

EMA

Total events

1

emaEuropean Medicines Agency· 1 event

2008-07-01Approval

Approval: Relistor (EMA)

Indication: Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

10

registered trials across all phases

LATEST COMPLETION 2023

7

Late-stage (III+)

6

Completed

4

Discontinued

PHASE DISTRIBUTIONn = 10

Phase 11Phase 22Phase 2 / 31Phase 32Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department

CompletedPH IVUniversity of Missouri-Columbian=152023

Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

CompletedPH IVBausch Health Americas, Inc.n=1562013

Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

WithdrawnPH IVBeth Israel Medical Center2011

An Open-Label Extension Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer

WithdrawnPH IIIBausch Health Americas, Inc.2024

A Phase II/III Adaptive Study to Evaluate the Safety and Efficacy of Oral Methylnaltrexone Bromide Tablets in Subjects With Advanced Pancreatic Cancer

WithdrawnPH II/IIIBausch Health Americas, Inc.2023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department

CompletedPH IVUniversity of Missouri-Columbian=152023

The Effect of Naloxone and Mehtylnaltrexone on Esophageal Sensitivity in Healthy Volunteers: a Randomized, Double-blind, Placebo-controlled Study

CompletedN/AUniversitaire Ziekenhuizen KU Leuvenn=122014

Phase II Trial of Subcutaneous Methylnaltrexone in the Treatment of Severe Opioid-induced Constipation in Cancer Patients

CompletedPH IIUniversity of Vermontn=122013

Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation

CompletedPH IVBausch Health Americas, Inc.n=1562013

A Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects

CompletedPH IBausch Health Americas, Inc.n=202010

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures

CompletedPH IIBausch Health Americas, Inc.n=372009

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.