Methylnaltrexone bromide
Methylnaltrexone, Relistor (methylnaltrexone bromide) is a small molecule pharmaceutical. Methylnaltrexone bromide was first approved as Relistor on 2008-04-24. It is used to treat constipation in the USA. It has been approved in Europe to treat constipation and opioid-related disorders. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target delta-type opioid receptor and kappa-type opioid receptor.
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| relistor | New Drug Application | 2024-05-14 |
Indications
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Agency Specific
FDA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Methylnaltrexone Bromide, Relistor, Salix | |||
| 8524276 | 2031-03-10 | DP | |
| 8956651 | 2031-03-10 | DP | |
| 9314461 | 2031-03-10 | DP | |
| 10307417 | 2031-03-10 | DP | |
| 10376505 | 2031-03-10 | DP | |
| 8420663 | 2029-09-30 | U-1185 | |
| 9180125 | 2029-09-30 | DP | U-1185 |
| 9492445 | 2029-09-30 | DP | U-1185 |
| 9724343 | 2029-09-30 | DP | U-1185 |
| Methylnaltrexone Bromide, Relistor, Salix Pharms | |||
| 8247425 | 2030-12-31 | U-1185 | |
| 8822490 | 2029-09-30 | DP | U-1185 |
| 8552025 | 2024-04-08 | DP | |
| 9669096 | 2024-04-08 | DP | |
| 10376584 | 2024-04-08 | DP | U-1185 |
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59 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | HP_0002019 | K59.0 | — | 4 | 8 | 7 | 3 | 21 |
| Opioid-induced constipation | D000079689 | — | — | — | 4 | 7 | 4 | 2 | 16 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 1 | — | 1 | — | 2 |
| Velopharyngeal insufficiency | D014681 | HP_0000220 | — | — | — | — | 2 | — | 2 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | — | 1 | — | 1 |
| Morphine dependence | D009021 | EFO_0005612 | — | — | — | — | 1 | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | — | 1 |
| Paralysis | D010243 | HP_0003470 | — | — | — | — | 1 | — | 1 |
| Esophageal motility disorders | D015154 | — | K22.4 | — | — | — | 1 | — | 1 |
| Esophageal diseases | D004935 | EFO_0009544 | K22.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ileus | D045823 | — | — | — | 2 | 2 | — | — | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | 2 | — | — | 2 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | 1 | 1 | — | — | 2 |
| Ventral hernia | D006555 | EFO_1001866 | K43 | — | — | 1 | — | — | 1 |
| Hernia | D006547 | HP_0100790 | K40-K46 | — | — | 1 | — | — | 1 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | 1 | 1 | — | — | 1 |
| Enteral nutrition | D004750 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | 1 | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | 1 | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intestinal obstruction | D007415 | — | K56.60 | 2 | — | — | — | — | 2 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 1 | 1 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methylnaltrexone bromide |
| INN | methylnaltrexone bromide |
| Description | Methylnaltrexone is a member of phenanthrenes. |
| Classification | Small molecule |
| Drug class | narcotic agonists/antagonists (normorphine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[N+]1(CC2CC2)CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5.[Br-] |
Identifiers
| PDB | — |
| CAS-ID | 83387-25-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201770 |
| ChEBI ID | — |
| PubChem CID | 5361918 |
| DrugBank | DB06800 |
| UNII ID | RFO6IL3D3M (ChemIDplus, GSRS) |
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1,045 adverse events reported
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