Relistor(methylnaltrexone)
Methylnaltrexone, Relistor (methylnaltrexone) is a small molecule pharmaceutical. Methylnaltrexone 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 kappa-type opioid receptor and delta-type opioid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Methylnaltrexone, Relistor
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Methylnaltrexone bromide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RELISTOR | Salix Pharmaceuticals | N-208271 RX | 2016-07-19 | 1 products, RLD, RS |
| RELISTOR | Salix Pharmaceuticals | N-021964 RX | 2008-04-24 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| relistor | New Drug Application | 2024-05-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | HP_0002019 | D003248 | K59.0 |
Agency Specific
FDA
EMA
No data
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 |
HCPCS
Code | Description |
|---|---|
| J2212 | Injection, methylnaltrexone, 0.1 mg |
Clinical
Clinical Trials
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 |
| 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 |
Identifiers
| PDB | — |
| CAS-ID | 83387-25-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1186579 |
| ChEBI ID | — |
| PubChem CID | 5361918 |
| DrugBank | DB06800 |
| UNII ID | RFO6IL3D3M (ChemIDplus, GSRS) |
Target
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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1,045 adverse events reported
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