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Stendra, Spedra(avanafil)
Spedra, Stendra (avanafil) is a small molecule pharmaceutical. Avanafil was first approved as Stendra on 2012-04-27. It is used to treat erectile dysfunction in the USA. It has been approved in Europe to treat erectile dysfunction.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
mental disordersD001523
Trade Name
FDA
EMA
Stendra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Avanafil
Tradename
Company
Number
Date
Products
STENDRAMetuchen PharmaceuticalsN-202276 RX2012-04-27
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
stendraNew Drug Application2023-05-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
erectile dysfunctionEFO_0004234D007172F52.21
Agency Specific
FDA
EMA
Expiration
Code
AVANAFIL, STENDRA, METUCHEN PHARMS
2025-10-18M-282
Patent Expiration
Patent
Expires
Flag
FDA Information
Avanafil, Stendra, Metuchen Pharms
66569352025-04-27DS, DPU-155
75014092023-05-05DP
ATC Codes
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04B: Urologicals
— G04BE: Drugs used in erectile dysfunction
— G04BE10: Avanafil
HCPCS
No data
Clinical
Clinical Trials
24 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_0004234F52.218164—19
Ocular visionD014785———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAVANAFIL
INNavanafil
Description
Avanafil is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of 4-[(3-chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)pyrrolidin-1-yl]pyrimidine-5-carboxylic acid with the amino group of pyrimidin-2-ylmethylamine. Used for treatment of erectile dysfunction. It has a role as an EC 3.1.4.* (phosphoric diester hydrolase) inhibitor and a vasodilator agent. It is a member of pyrimidines, an aromatic amide, an organochlorine compound, a member of prolinols and a monocarboxylic acid amide.
Classification
Small molecule
Drug classphosphodiesterase type 5 inhibitors (PDE5) inhibitors: (PDE5) inhibitors containing a sulfonamide moiety
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1ccc(CNc2nc(N3CCC[C@H]3CO)ncc2C(=O)NCc2ncccn2)cc1Cl
Identifiers
PDB—
CAS-ID330784-47-9
RxCUI1291301
ChEMBL IDCHEMBL1963681
ChEBI ID66876
PubChem CID9869929
DrugBankDB06237
UNII IDDR5S136IVO (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Stendra - Auxilium Pharmaceuticals
$
€
£
₣
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Stendra - Vivus
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 509 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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271 adverse events reported
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