Overview
Avanafil is a phosphodiesterase-5 (PDE5) inhibitor used in the treatment of erectile dysfunction. In comparison with other drugs of the same class, it shows greater selectivity for PDE5 over PDE6 than both sildenafil and vardenafil but less selectivity than tadalafil, suggesting a relatively lower risk of visual disturbances associated with off-target PDE6 inhibition. It first received FDA approval on April 27, 2012, with subsequent EMA approval in June 2013.
Indication
Avanafil is indicated for the treatment of erectile dysfunction.
Associated Conditions
- Erectile Dysfunction
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/05/05 | Phase 4 | Completed | |||
2017/05/30 | Phase 4 | UNKNOWN | Eduardo Vargas-Baquero | ||
2015/07/20 | Phase 3 | Completed | |||
2015/06/22 | Phase 2 | Completed | |||
2014/01/10 | Phase 4 | Completed | |||
2013/01/15 | Phase 4 | Completed | |||
2012/10/12 | Phase 3 | Completed | JW Pharmaceutical | ||
2012/10/03 | Phase 4 | Completed | |||
2012/06/11 | Phase 1 | Completed | |||
2010/05/05 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Metuchen Pharmaceuticals, LLC | 72384-751 | ORAL | 50 mg in 1 1 | 8/5/2020 | |
| Metuchen Pharmaceuticals, LLC | 72384-753 | ORAL | 200 mg in 1 1 | 8/5/2020 | |
| Metuchen Pharmaceuticals, LLC | 72384-752 | ORAL | 100 mg in 1 1 | 8/5/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/21/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SPEDRA TABLET 100MG | SIN15879P | TABLET | 100MG | 1/24/2020 | |
| SPEDRA TABLET 200MG | SIN15881P | TABLET | 200MG | 1/24/2020 | |
| SPEDRA TABLET 50MG | SIN15880P | TABLET | 50MG | 1/24/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SPEDRA TABLETS 100MG | N/A | N/A | N/A | 8/31/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SPEDRA avanafil 200 mg tablet blister pack | 228476 | A Menarini Australia Pty Ltd | Medicine | A | 4/6/2016 |
| SPEDRA avanafil 50 mg tablet blister pack | 228474 | A Menarini Australia Pty Ltd | Medicine | A | 4/6/2016 |
| SPEDRA avanafil 100 mg tablet blister pack | 228475 | A Menarini Australia Pty Ltd | Medicine | A | 4/6/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SPEDRA 50 mg comprimidos | 113841002 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SPEDRA 100 mg comprimidos | 113841005 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SPEDRA 200 mg comprimidos | 113841008 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SPEDRA 100 mg comprimidos | 113841004 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SPEDRA 50 mg comprimidos | 113841001 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SPEDRA 200 mg comprimidos | 113841009 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SPEDRA 100 mg comprimidos | 113841006 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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