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Drug ReportsUdenafil
Udenafil
Udenafil is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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Events Timeline
5D
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
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Indications
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Agency Specific
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EMA
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Patent Expiration
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ATC Codes
G: Genito urinary system and sex hormones
G04: Urologicals
G04B: Urologicals
G04BE: Drugs used in erectile dysfunction
G04BE11: Udenafil
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD012004112
Prostatic neoplasmsD011471C6111
Microvascular anginaD01756611
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic hyperplasiaD011470EFO_0000284N4011
Vascular dementiaD015140F0111
Sigmoid neoplasmsD012811C18.711
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
Kidney diseasesD007674EFO_0003086N0822
Renal insufficiencyD051437HP_0000083N1922
Urologic diseasesD014570N39.922
SpermatogenesisD01309111
Hepatic insufficiencyD04855011
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUdenafil
INNudenafil
Description
The drug udenafil is marketed under the trade name Zydena. It is within the PDE5 inhibitor class (which also includes avanafil, sildenafil, tadalafil, and vardenafil). Like other PDE5 inhibitors, it is used to treat erectile dysfunction. Udenafil was developed by Dong-A Pharmaceutical. It has fairly rapid onset of action (peak plasma concentration after 1 to 1.5 hours), and has long duration of action (plasma half-life of 11 to 13 hours). Udenafil's pharmacokinetics allows once-daily dosage (in addition to on-demand use). Typical doses are 100 and 200 mg. Udenafil is available in Korea, Russia, and the Philippines. It has not yet been approved for use in the United States by the U.S. Food and Drug Administration.
Classification
Small molecule
Drug classphosphodiesterase type 5 inhibitors (PDE5) inhibitors: (PDE5) inhibitors containing a sulfonamide moiety
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Structure (InChI/SMILES or Protein Sequence)
CCCOc1ccc(S(=O)(=O)NCCC2CCCN2C)cc1-c1nc2c(CCC)nn(C)c2c(=O)[nH]1
Identifiers
PDB
CAS-ID268203-93-6
RxCUI
ChEMBL IDCHEMBL2103849
ChEBI ID
PubChem CID6918523
DrugBankDB06267
UNII IDL5IB4XLY36 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 456 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2 adverse events reported
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