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naldemedine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| opioid receptor antagonists/agonists related to normorphine | 5220 | 916072-89-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Naldemedine is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 1.14 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1 | 29 | |||
| kinase-selectivity-class | AXL,EIF2AK3,GRK2,MAP2K6,TEK | 5 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 18, 2019 | EMA | SHIONOGI B.V. | |
| March 23, 2017 | FDA | SHIONOGI INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 74.07 | 40.32 | 33 | 1119 | 106837 | 90520458 |
| Hepatic function abnormal | 54.84 | 40.32 | 21 | 1131 | 46267 | 90581028 |
| Interstitial lung disease | 41.63 | 40.32 | 20 | 1132 | 76385 | 90550910 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Interstitial lung disease | 82.00 | 31.12 | 45 | 1525 | 78417 | 42541348 |
| Malignant neoplasm progression | 56.58 | 31.12 | 40 | 1530 | 108360 | 42511405 |
| Immune-mediated hepatic disorder | 51.42 | 31.12 | 13 | 1557 | 2501 | 42617264 |
| Delirium | 48.98 | 31.12 | 28 | 1542 | 52491 | 42567274 |
| Renal ischaemia | 46.15 | 31.12 | 11 | 1559 | 1659 | 42618106 |
| Immune-mediated enterocolitis | 45.13 | 31.12 | 14 | 1556 | 5663 | 42614102 |
| Hepatic function abnormal | 44.12 | 31.12 | 26 | 1544 | 51541 | 42568224 |
| Cytokine release syndrome | 36.89 | 31.12 | 22 | 1548 | 44505 | 42575260 |
| Decreased appetite | 36.53 | 31.12 | 40 | 1530 | 193097 | 42426668 |
| Cholangitis sclerosing | 34.80 | 31.12 | 9 | 1561 | 1893 | 42617872 |
| Non-small cell lung cancer | 34.27 | 31.12 | 11 | 1559 | 4963 | 42614802 |
| Immune-mediated lung disease | 33.75 | 31.12 | 10 | 1560 | 3463 | 42616302 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Interstitial lung disease | 122.25 | 32.22 | 63 | 2761 | 139271 | 110447204 |
| Malignant neoplasm progression | 108.93 | 32.22 | 63 | 2761 | 174504 | 110411971 |
| Hepatic function abnormal | 97.85 | 32.22 | 47 | 2777 | 89248 | 110497227 |
| Immune-mediated hepatic disorder | 73.34 | 32.22 | 18 | 2806 | 4432 | 110582043 |
| Delirium | 64.21 | 32.22 | 41 | 2783 | 134984 | 110451491 |
| Immune-mediated enterocolitis | 58.58 | 32.22 | 18 | 2806 | 10167 | 110576308 |
| Cytokine release syndrome | 56.42 | 32.22 | 30 | 2794 | 70276 | 110516199 |
| Decreased appetite | 54.97 | 32.22 | 64 | 2760 | 475782 | 110110693 |
| Platelet count decreased | 52.70 | 32.22 | 45 | 2779 | 230398 | 110356077 |
| Non-small cell lung cancer | 49.81 | 32.22 | 15 | 2809 | 7920 | 110578555 |
| Renal ischaemia | 46.53 | 32.22 | 11 | 2813 | 2312 | 110584163 |
| Cholangitis | 46.50 | 32.22 | 17 | 2807 | 16318 | 110570157 |
| Anaemia | 41.79 | 32.22 | 60 | 2764 | 547026 | 110039449 |
| Febrile neutropenia | 38.84 | 32.22 | 44 | 2780 | 316723 | 110269752 |
| Cancer pain | 34.87 | 32.22 | 11 | 2813 | 6761 | 110579714 |
| Neutrophil count decreased | 34.73 | 32.22 | 27 | 2797 | 120914 | 110465561 |
| Diarrhoea | 34.69 | 32.22 | 84 | 2740 | 1139421 | 109447054 |
| Immune-mediated lung disease | 33.17 | 32.22 | 10 | 2814 | 5293 | 110581182 |
| Cholangitis sclerosing | 32.41 | 32.22 | 9 | 2815 | 3573 | 110582902 |
| Pneumonia bacterial | 32.32 | 32.22 | 15 | 2809 | 26246 | 110560229 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A06AH05 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Peripheral opioid receptor antagonists |
| FDA MoA | N0000000154 | Opioid Antagonists |
| FDA EPC | N0000175691 | Opioid Antagonist |
| CHEBI has role | CHEBI:50503 | laxative |
Related Drugs by ATC class:
A06AH Peripheral opioid receptor antagonists 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Therapeutic opioid induced constipation | indication | 136801000119102 | |
| Gastrointestinal obstruction | contraindication | 126765001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.64 | acidic |
| pKa2 | 9.8 | acidic |
| pKa3 | 11.9 | acidic |
| pKa4 | 13.58 | acidic |
| pKa5 | 6.59 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.2MG BASE | SYMPROIC | BDSI | N208854 | March 23, 2017 | RX | TABLET | ORAL | RE46375 | Oct. 5, 2026 | TREATMENT OF OPIOID-INDUCED CONSTIPATION |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Mu-type opioid receptor | GPCR | ANTAGONIST | Ki | 8.95 | IUPHAR | DRUG LABEL | |||
| Delta-type opioid receptor | GPCR | ANTAGONIST | Ki | 9.04 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| 03KSI6WLXH | UNII |
| 1345728-04-2 | SECONDARY_CAS_RN |
| 4036929 | VANDF |
| C4325235 | UMLSCUI |
| CHEBI:751608 | CHEBI |
| CHEMBL2105755 | ChEMBL_ID |
| 54732242 | PUBCHEM_CID |
| DB11691 | DRUGBANK_ID |
| D10188 | KEGG_DRUG |
| CHEMBL3039508 | ChEMBL_ID |
| 9484 | INN_ID |
| C000620491 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9150 | IUPHAR_LIGAND_ID |
| 37800111000001102 | SNOMEDCT_US |
| 733465009 | SNOMEDCT_US |
| 763565000 | SNOMEDCT_US |
| 259144 | MMSL |
| 32868 | MMSL |
| d08609 | MMSL |
| 017143 | NDDF |
| 017144 | NDDF |
| 1876597 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SYMPROIC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59385-041 | TABLET | 0.20 mg | ORAL | NDA | 30 sections |