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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 conditionsD013568
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
SYMPROICBioDelivery SciencesN-208854 RX2017-03-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
symproicNew Drug Application2020-07-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
constipationHP_0002019D003248K59.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Naldemedine Tosylate, Symproic, Bdsi
109529682033-05-13DS, DP
91089752031-11-11DS, DP
RE463652028-01-11DS, DP
RE463752026-10-05DS, DPU-1185
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AH: Peripheral opioid receptor antagonists
— A06AH05: Naldemedine
HCPCS
No data
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-induced constipationD000079689133—17
PancreatitisD010195EFO_0000278K85—11——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNALDEMEDINE
INNnaldemedine
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 classnarcotic 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-ID916072-89-4
RxCUI1876597
ChEMBL IDCHEMBL2105755
ChEBI ID—
PubChem CID135626906
DrugBankDB11691
UNII ID03KSI6WLXH (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
OPRM1
Organism
Homo sapiens
Gene name
OPRM1
Gene synonyms
MOR1
NCBI Gene ID
4988
Protein name
mu-type opioid receptor
Protein synonyms
hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a
Uniprot ID
Q9UN57
Mouse ortholog
Oprm1 (18390)
mu-type opioid receptor (P42866)
Alternate
OPRD1
OPRD1
Organism
Homo sapiens
Gene name
OPRD1
Gene synonyms
OPRD
NCBI Gene ID
4985
Protein name
delta-type opioid receptor
Protein synonyms
D-OR-1, delta opioid receptor 1, DOR-1
Uniprot ID
P41143
Mouse ortholog
Oprd1 (18386)
delta-type opioid receptor (P32300)
Variants
Clinical Variant
No data
Financial
Symproic - BioDelivery Sciences
$
€
£
₣
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Symproic - Collegium Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 193 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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100 adverse events reported
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