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zafirlukast 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| leukotriene receptor antagonists | 2855 | 107753-78-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a leukotriene D4 receptor antagonist
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 40 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.99 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 2.597 | Moderate | 0.75 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 14.060 | Moderate | 0.75 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 44.361 | 10^-6 cm/s | Moderate | 0.75 |
| dh-clint | Dog hepatocyte intrinsic clearance | 7.295 | uL/min/10^6 cells | Moderate | 0.75 |
| dppb | Dog plasma protein binding (% unbound) | 0.220 | % | Moderate | 0.75 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 0.280 | % | Moderate | 0.75 |
| herg | hERG pIC50 | 4.598 | pIC50 | Moderate | 0.75 |
| hh-clint | Human hepatocyte intrinsic clearance | 12.823 | uL/min/10^6 cells | Moderate | 0.75 |
| hlm-clint | Human liver microsomal intrinsic clearance | 54.200 | uL/min/mg protein | Moderate | 0.75 |
| hppb | Human plasma protein binding (% unbound) | 0.270 | % | Moderate | 0.75 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,IKBKB,ITK,JAK1,JAK2,KIT,MAP2K1,MAP2K6,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK1,MAPK7,MAPK8,MAPK9,MAPKAPK2,MAPKAPK3,MARK4,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 | 61 | |||
| kinase-selectivity-class | AXL,EIF2AK3,ERBB2,GRK2,MAPK7,PDK1,PDK4,SIK2,STK33,TEK | 10 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 10.641 | Moderate | 0.75 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 9.419 | Moderate | 0.75 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.160 | Moderate | 0.75 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 27.479 | Moderate | 0.75 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 0.330 | % | Moderate | 0.75 |
| rh-clint | Rat hepatocyte intrinsic clearance | 14.825 | uL/min/10^6 cells | Moderate | 0.75 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 4.870 | % | Moderate | 0.75 |
| rppb | Rat plasma protein binding (% unbound) | 0.180 | % | Moderate | 0.75 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 66.222 | uM | Moderate | 0.75 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 26, 1996 | FDA | PAR PHARM 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 |
|---|---|---|---|---|---|---|
| Asthma | 70.02 | 24.06 | 45 | 1398 | 242115 | 90384889 |
| Dyspnoea | 26.75 | 24.06 | 49 | 1394 | 880906 | 89746098 |
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 |
|---|---|---|---|---|---|---|
| Asthma | 64.36 | 44.66 | 26 | 555 | 62288 | 42558466 |
| Precancerous condition | 59.63 | 44.66 | 8 | 573 | 118 | 42620636 |
| Sputum purulent | 52.57 | 44.66 | 9 | 572 | 703 | 42620051 |
| Prolonged expiration | 52.25 | 44.66 | 8 | 573 | 309 | 42620445 |
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 |
|---|---|---|---|---|---|---|
| Asthma | 81.81 | 28.49 | 49 | 1590 | 250242 | 110337418 |
| Precancerous condition | 46.67 | 28.49 | 8 | 1631 | 575 | 110587085 |
| Sputum purulent | 42.97 | 28.49 | 9 | 1630 | 1889 | 110585771 |
| Prolonged expiration | 38.86 | 28.49 | 8 | 1631 | 1544 | 110586116 |
| Wheezing | 34.05 | 28.49 | 29 | 1610 | 255201 | 110332459 |
| Dyspnoea | 32.19 | 28.49 | 58 | 1581 | 1106814 | 109480846 |
| Chest discomfort | 30.05 | 28.49 | 23 | 1616 | 173825 | 110413835 |
| Sputum discoloured | 28.85 | 28.49 | 12 | 1627 | 27933 | 110559727 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R03DC01 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Leukotriene receptor antagonists |
| FDA MoA | N0000000083 | Leukotriene Receptor Antagonists |
| MeSH PA | D006727 | Hormone Antagonists |
| MeSH PA | D018927 | Anti-Asthmatic Agents |
| MeSH PA | D019141 | Respiratory System Agents |
| MeSH PA | D020024 | Leukotriene Antagonists |
| FDA EPC | N0000175777 | Leukotriene Receptor Antagonist |
| FDA MoA | N0000185504 | Cytochrome P450 2C9 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:49159 | leukotriene antagonist |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
Related Drugs by ATC class:
R03DC Leukotriene receptor antagonists 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Asthma | indication | 195967001 | DOID:2841 |
| Asthma management | indication | 406162001 | |
| Suicidal thoughts | contraindication | 6471006 | |
| Hallucinations | contraindication | 7011001 | |
| Mood swings | contraindication | 18963009 | |
| Cirrhosis of liver | contraindication | 19943007 | DOID:5082 |
| Feeling agitated | contraindication | 24199005 | |
| Depressive disorder | contraindication | 35489007 | |
| Anxiety | contraindication | 48694002 | |
| Dream disorder | contraindication | 85418005 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Insomnia | contraindication | 193462001 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Nervousness | contraindication | ||
| Tremors | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.84 | acidic |
| pKa2 | 10.83 | acidic |
Orange Book patent data (new drug applications)
None
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 |
|---|---|---|---|---|---|---|---|---|---|
| Cysteinyl leukotriene receptor 1 | GPCR | ANTAGONIST | Ki | 9.50 | CHEMBL | CHEMBL | |||
| Adenosine receptor A3 | GPCR | Ki | 6.11 | DRUG MATRIX | |||||
| Cytochrome P450 2C9 | Enzyme | IC50 | 5.65 | DRUG MATRIX | |||||
| Cytosolic phospholipase A2 | Enzyme | IC50 | 4.07 | CHEMBL | |||||
| Epidermal growth factor receptor | Kinase | IC50 | 5.24 | DRUG MATRIX | |||||
| Peroxisome proliferator-activated receptor gamma | Nuclear hormone receptor | EC50 | 5.61 | CHEMBL | |||||
| Thromboxane-A synthase | Enzyme | IC50 | 5.42 | DRUG MATRIX | |||||
| Bile acid receptor | Nuclear hormone receptor | EC50 | 5.41 | CHEMBL | |||||
| Mitogen-activated protein kinase 3 | Kinase | IC50 | 5.36 | DRUG MATRIX | |||||
| Cysteinyl leukotriene receptor 2 | GPCR | ANTAGONIST | IC50 | 5.15 | IUPHAR | ||||
| Mitogen-activated protein kinase 14 | Kinase | IC50 | 6.45 | DRUG MATRIX | |||||
| Leukotriene B4 receptor 1 | GPCR | Ki | 5.15 | PDSP | |||||
| Bifunctional epoxide hydrolase 2 | Enzyme | IC50 | 5.70 | CHEMBL | |||||
| Mitogen-activated protein kinase 1 | Kinase | IC50 | 6.27 | DRUG MATRIX | |||||
| Solute carrier family 22 member 2 | Transporter | IC50 | 5.01 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 1 | Transporter | IC50 | 5.89 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 2 | Transporter | IC50 | 5.12 | CHEMBL | |||||
| Sodium/bile acid cotransporter | Transporter | IC50 | 5.19 | CHEMBL | |||||
| Prostaglandin E synthase | Enzyme | IC50 | 4.74 | CHEMBL | |||||
| Cytochrome P450 3A4 | Enzyme | Ki | 4.87 | WOMBAT-PK | |||||
| Exportin-1 | Nuclear other | Kd | 5 | CHEMBL | |||||
| Cysteinyl leukotriene receptor 1 | GPCR | Ki | 9.52 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4020987 | VUID |
| N0000148457 | NUI |
| D00411 | KEGG_DRUG |
| 4020987 | VANDF |
| C0378466 | UMLSCUI |
| CHEBI:10100 | CHEBI |
| ZLK | PDB_CHEM_ID |
| CHEMBL603 | ChEMBL_ID |
| DB00549 | DRUGBANK_ID |
| C062735 | MESH_SUPPLEMENTAL_RECORD_UI |
| 3322 | IUPHAR_LIGAND_ID |
| 7244 | INN_ID |
| XZ629S5L50 | UNII |
| 5717 | PUBCHEM_CID |
| 114970 | RXNORM |
| 178409 | MMSL |
| 5701 | MMSL |
| d04053 | MMSL |
| 006206 | NDDF |
| 108614003 | SNOMEDCT_US |
| 386880006 | SNOMEDCT_US |
| XZ629S5L50 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Zafirlukast | Human Prescription Drug Label | 1 | 31722-007 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 19 sections |
| Zafirlukast | Human Prescription Drug Label | 1 | 31722-008 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 19 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-970 | TABLET, COATED | 10 mg | ORAL | NDA | 12 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-971 | TABLET, COATED | 20 mg | ORAL | NDA | 12 sections |
| ACCOLATE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0203 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 22 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55111-625 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 22 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55111-626 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 22 sections |
| Zafirlukast | Human Prescription Drug Label | 1 | 59651-291 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 20 sections |
| Zafirlukast | Human Prescription Drug Label | 1 | 59651-292 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 20 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64380-187 | TABLET, COATED | 10 mg | ORAL | NDA | 12 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64380-187 | TABLET, COATED | 10 mg | ORAL | NDA | 12 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64380-188 | TABLET, COATED | 20 mg | ORAL | NDA | 12 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64380-188 | TABLET, COATED | 20 mg | ORAL | NDA | 12 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68084-059 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 22 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-1977 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 22 sections |
| Zafirlukast | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2361 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 19 sections |