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)
Comparisons Of The Bioavailability And Pharmacodynamics Of Various Formulations Of MOA-728 In Subjects On Methadone
Phase 1
Completed
- Conditions
- Metahdone-maintenance Subjects
- First Posted Date
- 2006-11-10
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Registration Number
- NCT00398502
Dose Ranging Study in Healthy Methadone Maintenance Subjects
Phase 1
Completed
- Conditions
- Adult
- First Posted Date
- 2006-10-13
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Target Recruit Count
- 16
- Registration Number
- NCT00387491
Bioequivalence Study in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- First Posted Date
- 2006-10-13
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Registration Number
- NCT00387985
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Phase 3
Completed
- Conditions
- Post Operative Bowel Dysfunction
- First Posted Date
- 2006-10-13
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Target Recruit Count
- 495
- Registration Number
- NCT00387309
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
Phase 2
Completed
- Conditions
- Constipation
- First Posted Date
- 2006-08-21
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Target Recruit Count
- 420
- Registration Number
- NCT00366431
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
Phase 1
Completed
- Conditions
- Postoperative ComplicationsConstipation
- First Posted Date
- 2006-04-05
- Last Posted Date
- 2019-11-25
- Lead Sponsor
- Bausch Health Americas, Inc.
- Target Recruit Count
- 48
- Registration Number
- NCT00311350
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