MedPath

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)

Open-Label Treatment Extension of Protocol MNTX 302

Phase 3
Completed
Conditions
Terminal Illness
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
89
Registration Number
NCT01367613
Locations
🇺🇸

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

Open-Label Treatment Extension of Protocol MNTX 301

Phase 3
Completed
Conditions
Terminal Illness
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
27
Registration Number
NCT01367600
Locations
🇺🇸

Progenics Pharmaceuticals, Tarrytown, New York, United States

Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Phase 2
Completed
Conditions
Postoperative Ileus
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
65
Registration Number
NCT01367548
Locations
🇺🇸

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

Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
6
Registration Number
NCT01367496
Locations
🇺🇸

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

Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

Phase 1
Completed
Conditions
Healthy Male Volunteers
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
6
Registration Number
NCT01367483
Locations
🇺🇸

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

Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

Phase 2
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
12
Registration Number
NCT01367587
Locations
🇺🇸

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

Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Phase 1
Completed
Conditions
Healthy Adults
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
54
Registration Number
NCT01367535
Locations
🇺🇸

Progenics Pharmaceuticals, Tarrytown, New York, United States

Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function

Phase 1
Completed
Conditions
Liver Dysfunction
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
24
Registration Number
NCT01367522
Locations
🇺🇸

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

Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Phase 2
Completed
Conditions
Bowel Dysfunction
Interventions
First Posted Date
2011-06-07
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
39
Registration Number
NCT01367574
Locations
🇺🇸

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

Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

Phase 1
Completed
Conditions
Healthy Males
Interventions
First Posted Date
2011-06-07
Last Posted Date
2023-04-12
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
15
Registration Number
NCT01367561
Locations
🇺🇸

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

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