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
Vardenafil (discontinued: Levitra, Staxyn, Vardenafil)
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 | — |
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 3,249 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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