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vardenafil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| inhibitors of phosphodiesterase PDE5 with vasodilator action | 2809 | 224785-90-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A piperazine derivative, PHOSPHODIESTERASE 5 INHIBITOR and VASODILATOR AGENT that is used as a UROLOGICAL AGENT in the treatment of ERECTILE DYSFUNCTION.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.11 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 4 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.58 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 15 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 3 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 13 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.05 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 4.50 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.202 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.107 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 50.234 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 16.520 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 9.560 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 25.750 | % | High | 1 |
| herg | hERG pIC50 | 5.012 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 21.478 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 253.513 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 6.360 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,PDK1,PDK2,PIK3CB,PIK3CD,PRKDC,TEK | 20 | |||
| kinase-selectivity-class | AXL,BRAF,CDK9,GRK2,MAPK7 | 5 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 3.581 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 68.234 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 5.120 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 9.727 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 17.710 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 81.846 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 44.440 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 6.310 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 10.520 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 19, 2003 | FDA | BAYER HLTHCARE |
FDA Adverse Event Reporting System (Female)
None
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 |
|---|---|---|---|---|---|---|
| Enterocolitis infectious | 106.71 | 22.48 | 23 | 1752 | 1960 | 42617600 |
| Accessory spleen | 57.11 | 22.48 | 9 | 1766 | 131 | 42619429 |
| Optic ischaemic neuropathy | 48.56 | 22.48 | 13 | 1762 | 2762 | 42616798 |
| Food interaction | 44.66 | 22.48 | 10 | 1765 | 1012 | 42618548 |
| Biliary tract infection | 30.33 | 22.48 | 7 | 1768 | 811 | 42618749 |
| Hepatic cyst | 29.65 | 22.48 | 9 | 1766 | 2989 | 42616571 |
| Macular thickening | 28.29 | 22.48 | 4 | 1771 | 26 | 42619534 |
| Drug ineffective | 26.48 | 22.48 | 71 | 1704 | 630126 | 41989434 |
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 |
|---|---|---|---|---|---|---|
| Accessory spleen | 63.77 | 24.94 | 9 | 1435 | 204 | 110587651 |
| Food interaction | 48.81 | 24.94 | 10 | 1434 | 2142 | 110585713 |
| Enterocolitis infectious | 44.12 | 24.94 | 10 | 1434 | 3434 | 110584421 |
| Biliary tract infection | 33.22 | 24.94 | 7 | 1437 | 1717 | 110586138 |
| Macular thickening | 31.49 | 24.94 | 4 | 1440 | 39 | 110587816 |
| Hepatic cyst | 31.48 | 24.94 | 9 | 1435 | 7774 | 110580081 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G04BE09 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs used in erectile dysfunction |
| FDA MoA | N0000020026 | Phosphodiesterase 5 Inhibitors |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D010726 | Phosphodiesterase Inhibitors |
| MeSH PA | D014665 | Vasodilator Agents |
| MeSH PA | D058986 | Phosphodiesterase 5 Inhibitors |
| MeSH PA | D064804 | Urological Agents |
| FDA EPC | N0000175599 | Phosphodiesterase 5 Inhibitor |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:50218 | EC 3.1.4.* (phosphoric diester hydrolase) inhibitor |
Related Drugs by ATC class:
G04BE Drugs used in erectile dysfunction 9 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Impotence | indication | 397803000 | |
| Induratio penis plastica | contraindication | 1335005 | DOID:8616 |
| Priapism | contraindication | 6273006 | DOID:9286 |
| Hearing loss | contraindication | 15188001 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Fibrosis of corpus cavernosum | contraindication | 32608004 | |
| Low blood pressure | contraindication | 45007003 | |
| Chronic heart failure | contraindication | 48447003 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Aortic valve stenosis | contraindication | 60573004 | DOID:1712 |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Leukemia, disease | contraindication | 93143009 | DOID:1240 |
| Multiple myeloma | contraindication | 109989006 | DOID:9538 |
| Hb SS disease | contraindication | 127040003 | DOID:10923 |
| Acute peptic ulcer | contraindication | 196682000 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Penis bent | contraindication | 249247007 | |
| Idiopathic hypertrophic subaortic stenosis | contraindication | 360465008 | |
| Acute coronary syndrome | contraindication | 394659003 | |
| Anterior ischemic optic neuropathy | contraindication | 404659001 | |
| Congenital long QT syndrome | contraindication | 442917000 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Pigmentary Retinopathy | contraindication | ||
| Life-Threatening Cardiac Arrhythmias | 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 | 7.87 | Basic |
| pKa2 | 6.57 | Basic |
| pKa3 | 5.17 | 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 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LEVITRA | BAYER HLTHCARE | N021400 | Aug. 19, 2003 | DISCN | TABLET | ORAL | 8273876 | July 23, 2027 | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET |
| EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LEVITRA | BAYER HLTHCARE | N021400 | Aug. 19, 2003 | DISCN | TABLET | ORAL | 8273876 | July 23, 2027 | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET |
| EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LEVITRA | BAYER HLTHCARE | N021400 | Aug. 19, 2003 | DISCN | TABLET | ORAL | 8273876 | July 23, 2027 | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET |
| EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LEVITRA | BAYER HLTHCARE | N021400 | Aug. 19, 2003 | DISCN | TABLET | ORAL | 8273876 | July 23, 2027 | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET |
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 |
|---|---|---|---|---|---|---|---|---|---|
| cGMP-specific 3',5'-cyclic phosphodiesterase | Enzyme | INHIBITOR | IC50 | 9.16 | WOMBAT-PK | CHEMBL | |||
| Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha | Enzyme | IC50 | 7.47 | WOMBAT-PK | |||||
| Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A | Enzyme | IC50 | 6.89 | CHEMBL | |||||
| Calcium/calmodulin-dependent 3',5'-cyclic nucleotide phosphodiesterase 1A | Enzyme | IC50 | 7.04 | WOMBAT-PK | |||||
| cAMP and cAMP-inhibited cGMP 3',5'-cyclic phosphodiesterase 10A | Enzyme | IC50 | 6.10 | CHEMBL | |||||
| cGMP-dependent 3',5'-cyclic phosphodiesterase | Enzyme | IC50 | 5.51 | CHEMBL | |||||
| High affinity cGMP-specific 3',5'-cyclic phosphodiesterase 9A | Enzyme | IC50 | 6.34 | CHEMBL | |||||
| Phosphodiesterase 3 | Enzyme | IC50 | 5.68 | CHEMBL | |||||
| Phosphodiesterase 4 | Enzyme | IC50 | 5.35 | CHEMBL | |||||
| Phosphodiesterase 1 | Enzyme | IC50 | 6.74 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021404 | VUID |
| N0000148820 | NUI |
| D03260 | KEGG_DRUG |
| 224789-15-5 | SECONDARY_CAS_RN |
| 330808-88-3 | SECONDARY_CAS_RN |
| 4021404 | VANDF |
| C0971579 | UMLSCUI |
| CHEMBL1520 | ChEMBL_ID |
| CHEMBL1339 | ChEMBL_ID |
| CHEMBL2106480 | ChEMBL_ID |
| D000069058 | MESH_DESCRIPTOR_UI |
| DB00862 | DRUGBANK_ID |
| 7320 | IUPHAR_LIGAND_ID |
| 7950 | INN_ID |
| UCE6F4125H | UNII |
| 135400189 | PUBCHEM_CID |
| 1309396 | RXNORM |
| 17549 | MMSL |
| 47302 | MMSL |
| 83725 | MMSL |
| d04893 | MMSL |
| 009915 | NDDF |
| 009916 | NDDF |
| 404858007 | SNOMEDCT_US |
| 407979001 | SNOMEDCT_US |
| 412528004 | SNOMEDCT_US |
| 426182008 | SNOMEDCT_US |
| CHEBI:46295 | CHEBI |
| VDN | PDB_CHEM_ID |
| UCE6F4125H | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7652 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 27 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7653 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7654 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7655 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 27 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-2800 | TABLET | 2.50 mg | ORAL | ANDA | 28 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-2801 | TABLET | 5 mg | ORAL | ANDA | 28 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-2802 | TABLET | 10 mg | ORAL | ANDA | 28 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-2803 | TABLET | 20 mg | ORAL | ANDA | 28 sections |
| Vardenafil Hydrochloride | Human Prescription Drug Label | 1 | 33342-151 | TABLET | 2.50 mg | ORAL | ANDA | 26 sections |
| Vardenafil Hydrochloride | Human Prescription Drug Label | 1 | 33342-152 | TABLET | 5 mg | ORAL | ANDA | 26 sections |
| Vardenafil Hydrochloride | Human Prescription Drug Label | 1 | 33342-153 | TABLET | 10 mg | ORAL | ANDA | 26 sections |
| Vardenafil Hydrochloride | Human Prescription Drug Label | 1 | 33342-154 | TABLET | 20 mg | ORAL | ANDA | 26 sections |
| Vardenafil | Human Prescription Drug Label | 1 | 33342-203 | TABLET | 11.85 mg | ORAL | ANDA | 27 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-826 | TABLET | 5 mg | ORAL | ANDA | 28 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-847 | TABLET | 10 mg | ORAL | ANDA | 28 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-848 | TABLET | 20 mg | ORAL | ANDA | 28 sections |
| Levitra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-323 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 23 sections |
| Levitra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-741 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 23 sections |
| Levitra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-744 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 23 sections |
| Levitra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-748 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 23 sections |
| Vardenafil | Human Prescription Drug Label | 1 | 46708-235 | TABLET, ORALLY DISINTEGRATING | 10 mg | ORAL | ANDA | 27 sections |
| VARDENAFIL HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-236 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 27 sections |
| VARDENAFIL HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-237 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| VARDENAFIL HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-238 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| VARDENAFIL HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-239 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 27 sections |
| Levitra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4967 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 23 sections |
| Levitra | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4984 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 23 sections |
| Staxyn | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6333 | TABLET, ORALLY DISINTEGRATING | 10 mg | ORAL | NDA | 26 sections |
| Vardenafil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-864 | TABLET | 2.50 mg | ORAL | ANDA | 19 sections |
| Vardenafil | Human Prescription Drug Label | 1 | 62332-235 | TABLET, ORALLY DISINTEGRATING | 10 mg | ORAL | ANDA | 27 sections |