Stendra, Spedra(avanafil)
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 diseases | D000091642 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Avanafil, 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 |
|---|---|---|---|---|
| STENDRA | Metuchen Pharmaceuticals | N-202276 RX | 2012-04-27 | 3 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| erectile dysfunction | EFO_0004234 | D007172 | F52.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AVANAFIL, STENDRA, METUCHEN PHARMS | |||
| 2025-10-18 | M-282 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Avanafil, Stendra, Metuchen Pharms | |||
| 6656935 | 2025-04-27 | DS, DP | U-155 |
HCPCS
No data
Clinical
Clinical Trials
25 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 | 9 | 1 | 7 | 4 | — | 21 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | — | 1 | — | 1 |
| Ocular vision | D014785 | — | — | — | — | — | 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 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Avanafil |
| INN | avanafil |
| 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 class | phosphodiesterase 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-ID | 330784-47-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1963681 |
| ChEBI ID | 66876 |
| PubChem CID | 9869929 |
| DrugBank | DB06237 |
| UNII ID | DR5S136IVO (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Stendra – Auxilium Pharmaceuticals
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Stendra – Vivus
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 623 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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566 adverse events reported
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