Symproic, Rizmoic(naldemedine)
Rizmoic, Symproic (naldemedine) is a small molecule pharmaceutical. Naldemedine was first approved as Symproic on 2017-03-23. It is used to treat constipation in the USA. It has been approved in Europe to treat constipation. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target delta-type opioid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Symproic
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Naldemedine tosylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMPROIC | BioDelivery Sciences | N-208854 RX | 2017-03-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| symproic | New Drug Application | 2022-12-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | HP_0002019 | D003248 | K59.0 |
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-induced constipation | D000079689 | — | — | 1 | 4 | 3 | — | 1 | 8 |
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | 3 | 3 | — | 1 | 7 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pain | D059350 | HP_0012532 | — | — | 2 | — | — | — | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | 2 | — | — | — | 2 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | 2 | — | — | — | 2 |
Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Naldemedine |
| INN | naldemedine |
| Description | Naldemedine (brand name Symproic in the US and Rizmoic in the European Union) is a medication that is used for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. It is a peripherally acting μ-opioid receptor antagonist and was developed by Shionogi. Clinical studies have found it to possess statistically significant effectiveness for these indications and to be generally well tolerated, with predominantly mild to moderate gastrointestinal side effects. Effects indicative of central opioid withdrawal or impact on the analgesic or miotic effects of co-administered opioids have only been observed in a small number of patients.
|
| Classification | Small molecule |
| Drug class | narcotic agonists/antagonists (normorphine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(NC(=O)C1=C(O)[C@@H]2Oc3c(O)ccc4c3[C@@]23CCN(CC2CC2)[C@H](C4)[C@]3(O)C1)c1nc(-c2ccccc2)no1 |
Identifiers
| PDB | — |
| CAS-ID | 916072-89-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105755 |
| ChEBI ID | — |
| PubChem CID | 54732242 |
| DrugBank | DB11691 |
| UNII ID | 03KSI6WLXH (ChemIDplus, GSRS) |
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Symproic – BioDelivery Sciences
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Symproic – Collegium Pharmaceutical
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 245 documents
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Safety
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Adverse Events
Top Adverse Reactions
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616 adverse events reported
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