Levitra, Vivanza(vardenafil)
Levitra, Vardenafil (vardenafil) is a small molecule pharmaceutical. Vardenafil was first approved as Vivanza on 2003-03-04. It is used to treat vasculogenic impotence in the USA. It has been approved in Europe to treat erectile dysfunction. The pharmaceutical is active against cGMP-specific 3',5'-cyclic phosphodiesterase.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| levitra | New Drug Application | 2011-10-27 |
| staxyn | New Drug Application | 2012-04-23 |
| vardenafil | ANDA | 2024-08-14 |
| vardenafil hydrochloride | ANDA | 2024-09-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| vasculogenic impotence | EFO_1001234 | D018783 | — |
| erectile dysfunction | EFO_0004234 | D007172 | F52.21 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
82 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 3 | 5 | 23 | 24 | 7 | 60 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 2 | 3 | 3 | — | 8 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | 2 | 1 | 2 | — | 5 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | 3 | 1 | — | 4 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | 2 | 2 | — | 4 |
| Ischemia | D007511 | EFO_0000556 | — | 1 | — | — | 1 | 1 | 3 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | 1 | — | 3 |
| Ischemic optic neuropathy | D018917 | EFO_1000809 | H47.01 | — | — | — | 1 | 1 | 2 |
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | — | — | — | 1 | 1 | 2 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | 2 | 1 | — | 1 | 4 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | 1 | 1 | — | 1 | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | 1 | — | — | 2 |
| Premature ejaculation | D061686 | HP_0012876 | F52.4 | — | — | 1 | — | — | 1 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | 1 | — | — | 1 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | — | — | 1 | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | 1 | — | — | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | 1 | 1 | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | 2 | — | — | — | 2 |
| Tinnitus | D014012 | HP_0000360 | H93.1 | — | 1 | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | 1 | — | — | — | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Reperfusion injury | D015427 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary disease | D003327 | — | — | — | — | — | — | 1 | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Vardenafil |
| INN | vardenafil |
| Description | Vardenafil, sold under the brand name Levitra among others, is a medication that is used for treating erectile dysfunction. It is a PDE5 inhibitor. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | phosphodiesterase type 5 inhibitors (PDE5) inhibitors: (PDE5) inhibitors containing a sulfonamide moiety |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCc1nc(C)c2c(=O)nc(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)[nH]n12 |
Identifiers
| PDB | — |
| CAS-ID | 224785-90-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1520 |
| ChEBI ID | 46295 |
| PubChem CID | 110634 |
| DrugBank | DB00862 |
| UNII ID | UCE6F4125H (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PDE4B
PDE4B
Organism
Homo sapiens
Gene name
PDE4B
Gene synonyms
DPDE4
NCBI Gene ID
Protein name
cAMP-specific 3',5'-cyclic phosphodiesterase 4B
Protein synonyms
DPDE4, dunce-like phosphodiesterase E4, PDE32, phosphodiesterase 4B, cAMP-specific (phosphodiesterase E4 dunce homolog, Drosophila)
Uniprot ID
Mouse ortholog
Pde4b (18578)
cAMP-specific 3',5'-cyclic phosphodiesterase 4B (Q8VBU5)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Vardenafil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,221 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,986 adverse events reported
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