Levitra, Vivanza(vardenafil)
Levitra, Staxyn (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. In addition, it is known to target cAMP-specific 3',5'-cyclic phosphodiesterase 4B.
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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 | 2011-10-26 |
| staxyn | New Drug Application | 2012-04-23 |
| vardenafil | ANDA | 2023-05-30 |
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
75 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 | 22 | 23 | 7 | 58 |
| Pulmonary arterial hypertension | D000081029 | — | 2 | — | 2 | — | 4 | ||
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 1 | 1 | — | 2 | |
| Healthy volunteers/patients | — | 1 | — | — | 1 | — | 2 | ||
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | 1 | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 1 | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | 1 | — | — | 1 |
| Physiological sexual dysfunction | D012735 | — | — | 1 | — | — | 1 | ||
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | 1 | 1 | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic hyperplasia | D011470 | EFO_0000284 | N40 | — | 2 | — | — | 1 | 3 |
| Tinnitus | D014012 | HP_0000360 | H93.1 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | 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 | |
| Reperfusion injury | D015427 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 | 1XOT |
| CAS-ID | 224785-90-4 |
| RxCUI | 306674 |
| ChEMBL ID | CHEMBL1520 |
| ChEBI ID | 46295 |
| PubChem CID | 110634 |
| DrugBank | DB00862 |
| UNII ID | UCE6F4125H (ChemIDplus, GSRS) |
Target
Agency Approved
PDE5A
PDE5A
Organism
Homo sapiens
Gene name
PDE5A
Gene synonyms
PDE5
NCBI Gene ID
Protein name
cGMP-specific 3',5'-cyclic phosphodiesterase
Protein synonyms
CGB-PDE, cGMP-binding cGMP-specific 3',5'-cyclic nucleotide phosphodiesterase, cGMP-binding cGMP-specific phosphodiesterase, cGMP-specific phosphodiesterase PDE5A2, cGMP-specific phosphodiesterase type 5A, phosphodiesterase 5A, cGMP-specific, phosphodiesterase isozyme 5
Uniprot ID
Mouse ortholog
Pde5a (242202)
cGMP-specific 3',5'-cyclic phosphodiesterase (Q8CG03)
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,483 adverse events reported
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