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Methylnaltrexone

Generic Name
Methylnaltrexone
Brand Names
Relistor
Drug Type
Small Molecule
Chemical Formula
C21H26NO4
CAS Number
916055-93-1
Unique Ingredient Identifier
0RK7M7IABE
Background

Methylnaltrexone is a pheriphally-acting μ-opioid antagonist that acts on the gastrointestinal tract to decrease opioid-induced constipation without producing analgesic effects or withdrawal symptoms. It is also a weak CYP2D6 inhibitor. FDA approved in 2008.

Indication

Treatment of opioids induced constipation in palliative patients that are inadequately responding to laxative therapy.

Associated Conditions
Opioid Induced Constipation (OIC)
Clinical Trials
Related News

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Phase 3
Completed
Conditions
Ileus
Interventions
Drug: Placebo
First Posted Date
2007-09-14
Last Posted Date
2019-09-04
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
374
Registration Number
NCT00528970
Locations
🇰🇷

Kangnam-Gu, Seoul, Korea, Republic of

Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy

Phase 1
Withdrawn
Conditions
Methadone-maintenance Subjects
First Posted Date
2007-07-23
Last Posted Date
2019-11-29
Lead Sponsor
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Registration Number
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Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2007-04-24
Last Posted Date
2019-11-25
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Bausch Health Americas, Inc.
Target Recruit Count
36
Registration Number
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Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

Phase 1
Completed
Conditions
Methadone-maintenance Subjects
First Posted Date
2007-03-15
Last Posted Date
2019-11-25
Lead Sponsor
Bausch Health Americas, Inc.
Registration Number
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Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects

Phase 1
Completed
Conditions
Constipation
First Posted Date
2007-03-07
Last Posted Date
2019-11-25
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
24
Registration Number
NCT00444158

Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2007-02-13
Last Posted Date
2019-11-25
Lead Sponsor
Bausch Health Americas, Inc.
Registration Number
NCT00434395

Study Evaluating MOA-728 Administered in Healthy Men

Phase 1
Withdrawn
Conditions
Healthy
First Posted Date
2007-01-29
Last Posted Date
2019-11-29
Lead Sponsor
Bausch Health Americas, Inc.
Registration Number
NCT00427258

Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Phase 3
Completed
Conditions
Advance Illness Patients With OIC
Interventions
Drug: SC Placebo
First Posted Date
2006-11-22
Last Posted Date
2019-11-25
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
134
Registration Number
NCT00402038
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

Phase 3
Completed
Conditions
Post-Operative Ileus (POI)
Interventions
Drug: Placebo
First Posted Date
2006-11-20
Last Posted Date
2019-09-04
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
524
Registration Number
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Locations
🇺🇸

Progenics Pharmaceuticals, Tarrytown, New York, United States

A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

Phase 3
Completed
Conditions
Advanced Illness Patients With Opioid Induced Constipation
Interventions
Drug: SC Placebo
First Posted Date
2006-11-20
Last Posted Date
2019-11-25
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
154
Registration Number
NCT00401362
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

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