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istradefylline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| N-methylated xanthine derivatives | 4882 | 155270-99-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
selective antagonist at the A2A receptor, used in the treatment of Parkinson's disease
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.00 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 68 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.061 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.583 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 80.910 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 10.257 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 9.170 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 24.360 | % | High | 1 |
| herg | hERG pIC50 | 4.493 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 6.095 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 28.973 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 4.640 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,ALK,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,FLT3,GRK2,ITK,JAK1,MAP3K21,MAPK7,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PRKDC,SIK2,SIK3,STK33,TEK,TTK | 37 | |||
| kinase-selectivity-class | ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK16,CDK9,CSF1R,DDR1,FLT3,GRK2,IRAK1,IRAK3,MAP2K3,MAP2K6,MAP3K21,MAPK12,MAPK7,MARK4,MET,MTOR,PDK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PRKDC,SIK2,SIK3,STK33,TEK,ULK1,ZAP70 | 33 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.443 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 16.749 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 4.250 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 1.216 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 9.020 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 4.710 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 54.540 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 2.730 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 12.078 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 27, 2019 | FDA | KYOWA KIRIN | |
| March 15, 2013 | PMDA |
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 119.42 | 50.05 | 28 | 347 | 36506 | 90591566 |
| Hallucination | 62.37 | 50.05 | 19 | 356 | 65940 | 90562132 |
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 |
|---|---|---|---|---|---|---|
| Hallucination | 50.66 | 41.30 | 19 | 360 | 57488 | 42563468 |
| Dyskinesia | 48.46 | 41.30 | 15 | 364 | 25375 | 42595581 |
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 147.56 | 47.21 | 40 | 778 | 51406 | 110537075 |
| Hallucination | 93.26 | 47.21 | 33 | 785 | 101399 | 110487082 |
| Hallucination, visual | 69.28 | 47.21 | 21 | 797 | 39584 | 110548897 |
| Death | 65.28 | 47.21 | 48 | 770 | 698821 | 109889660 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N04CX01 | NERVOUS SYSTEM ANTI-PARKINSON DRUGS OTHER ANTIPARKINSON DRUGS Other antiparkinson drugs |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D058914 | Purinergic Antagonists |
| MeSH PA | D058915 | Purinergic P1 Receptor Antagonists |
| MeSH PA | D058917 | Adenosine A2 Receptor Antagonists |
| CHEBI has role | CHEBI:48407 | antiparkinson drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Parkinson's disease | indication | 49049000 | DOID:14330 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 1.59 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 20MG | NOURIANZ | KYOWA KIRIN | N022075 | Aug. 27, 2019 | RX | TABLET | ORAL | 7727993 | Jan. 28, 2028 | A METHOD OF REDUCING OFF TIME FROM L-DOPA THERAPY, COMPRISING ADMINISTERING, TO A HUMAN PATIENT WITH PARKINSONS DISEASE, AN EFFECTIVE AMOUNT OF ISTRADEFYLLINE, WHEREIN THE PATIENT CURRENTLY RECEIVES SAID L-DOPA THERAPY |
| 40MG | NOURIANZ | KYOWA KIRIN | N022075 | Aug. 27, 2019 | RX | TABLET | ORAL | 7727993 | Jan. 28, 2028 | A METHOD OF REDUCING OFF TIME FROM L-DOPA THERAPY, COMPRISING ADMINISTERING, TO A HUMAN PATIENT WITH PARKINSONS DISEASE, AN EFFECTIVE AMOUNT OF ISTRADEFYLLINE, WHEREIN THE PATIENT CURRENTLY RECEIVES SAID L-DOPA THERAPY |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Adenosine receptor A2a | GPCR | ANTAGONIST | Ki | 8.66 | CHEMBL | SCIENTIFIC LITERATURE | |||
| Amine oxidase [flavin-containing] B | Enzyme | Ki | 7.57 | CHEMBL | |||||
| Adenosine receptor A1 | GPCR | Ki | 6.08 | CHEMBL | |||||
| Adenosine receptor A3 | GPCR | Ki | 5.35 | CHEMBL | |||||
| Adenosine receptor A2b | GPCR | Ki | 5.75 | CHEMBL | |||||
| Adenosine receptor A1 | GPCR | Ki | 6.82 | CHEMBL | |||||
| Adenosine receptor A2a | GPCR | Ki | 8.70 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 2GZ0LIK7T4 | UNII |
| D04641 | KEGG_DRUG |
| 4038742 | VANDF |
| C0673470 | UMLSCUI |
| CHEBI:134726 | CHEBI |
| JQ9 | PDB_CHEM_ID |
| CHEMBL431770 | ChEMBL_ID |
| 5311037 | PUBCHEM_CID |
| DB11757 | DRUGBANK_ID |
| 8387 | INN_ID |
| C111599 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5608 | IUPHAR_LIGAND_ID |
| 2199015 | RXNORM |
| 322306 | MMSL |
| 37365 | MMSL |
| d09365 | MMSL |
| 018108 | NDDF |
| 789546007 | SNOMEDCT_US |
| 789550000 | SNOMEDCT_US |
| 2GZ0LIK7T4 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| NOURIANZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42747-602 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 31 sections |
| NOURIANZ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42747-604 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 31 sections |