Overview
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/08 | Phase 4 | Recruiting | |||
2021/06/18 | N/A | Withdrawn | |||
2021/03/09 | Not Applicable | Recruiting | |||
2021/02/08 | Phase 2 | Completed | Asbjørn Mohr Drewes | ||
2019/11/05 | Phase 3 | Withdrawn | |||
2019/09/10 | Phase 2 | Withdrawn | |||
2019/02/25 | Phase 2 | Completed | |||
2018/05/14 | Phase 4 | Completed | |||
2017/01/09 | Not Applicable | Completed | |||
2016/11/30 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Salix Pharmaceuticals, Inc. | 65649-551 | SUBCUTANEOUS | 12 mg in 0.6 mL | 12/12/2023 | |
| Salix Pharmaceuticals, Inc. | 65649-552 | SUBCUTANEOUS | 8 mg in 0.4 mL | 12/12/2023 | |
| Salix Pharmaceuticals, Inc. | 65649-150 | ORAL | 150 mg in 1 1 | 12/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/1/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Relistor Solution For Injection 12mg/0.6mL | SIN13783P | INJECTION, SOLUTION | 12mg/0.6mL | 4/7/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RELISTOR methylnaltrexone bromide 12 mg/0.6 mL solution for injection vial | 144062 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 11/17/2008 |
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