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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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Commercial
Clinical
Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
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
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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
FDA
EMA
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Indications
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EMA
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Agency Specific
FDA
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
Erectile dysfunctionD007172EFO_0004234F52.213361114
Rectal neoplasmsD012004112
Prostatic neoplasmsD011471C6111
Chest painD002637R07.911
Microvascular anginaD01756611
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart diseasesD006331EFO_0003777I51.911315
Univentricular heartD000080039Q20.411315
HypertensionD006973EFO_0000537I10234
Pulmonary arterial hypertensionD000081029212
Familial primary pulmonary hypertensionD065627I27.0212
Pulmonary hypertensionD006976EFO_0001361I27.2022
Heart failureD006333EFO_0003144I5022
Raynaud diseaseD011928EFO_1001145I73.0111
Alzheimer diseaseD000544EFO_0000249F0311
Systolic heart failureD054143EFO_1001207I50.2011
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic hyperplasiaD011470EFO_0000284N4011
HyperplasiaD006965EFO_000053611
Vascular dementiaD015140F0111
DementiaD003704EFO_0003862F0311
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 insufficiencyD051437N1922
Urologic diseasesD014570N39.922
SpermatogenesisD01309111
Liver diseasesD008107EFO_0001421K70-K7711
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
Image (chem structure or protein)Loading
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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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