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
Relistor (discontinued: Methylnaltrexone)
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 | — | 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 | — | K59.0 | — | 2 | 6 | 3 | 1 | 12 |
| Opioid-induced constipation | D000079689 | — | — | — | 2 | 5 | 3 | 1 | 11 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ileus | D045823 | — | K56.7 | — | 1 | 2 | — | — | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | 2 | — | — | 2 |
| Intestinal diseases | D007410 | — | K63.9 | — | 1 | 1 | — | — | 2 |
| Ventral hernia | D006555 | EFO_1001866 | K43 | — | — | 1 | — | — | 1 |
| Hernia | D006547 | — | K40-K46 | — | — | 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 |
| Gastrointestinal diseases | D005767 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 908 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,069 adverse events reported
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