Drugs / Avanafil
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | STENDRA | — | 2014-09-17 – 2022-10-18 | fda.gov ↗ |
| Approved | EU (EMA) | Spedra | — | 2013-06-21 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Spedra | — | 2013-04-26 | europa.eu ↗ |
| Approved | US (FDA) | STENDRA | — | 2012-04-27 | fda.gov ↗ |
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT01095601 | Apr → May 2010 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01117038 | Apr → May 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01095588 | Apr → May 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01100021 | Feb → Mar 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01054261 | Jan → Feb 2010 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01054430 | Jan → Feb 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00914511 | May → Jun 2009 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00770042 | Oct → Nov 2008 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00769041 | Oct 2008 → Jan 2009 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01616485 | Mar → May 2004 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02477436 | Feb → Sep 2008 | erectile dysfunction | Pusan National University Hospital | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT02503306 | Jul 2015 → Mar 2016 | erectile dysfunction | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00895011 | Apr 2009 → Apr 2011 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 3 | NCT00903981 | Mar → Oct 2009 | erectile dysfunction | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00853606 | Mar 2009 → Apr 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 3 | NCT00809471 | Dec 2008 → Feb 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 3 | NCT00790751 | Nov 2008 → Aug 2009 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02033200 | Jan 2014 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT01768676 | Dec 2012 → Aug 2014 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT01698684 | Sep 2012 → Apr 2013 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01054859 Comparator | Jan 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01705197 Comparator | Feb 2012 → Apr 2013 | erectile dysfunction | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04374994 Comparator | Sep 2018 → Apr 2019 | erectile dysfunction | University of Alexandria | Completed | No outcome recorded |
| Phase 4 | NCT03169582 Comparator | Apr 2016 → Jun 2018 | erectile dysfunction | Eduardo Vargas-Baquero | Unknown | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | avanafil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00809471 ↗ |
| Known as | Avanafilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1963681 ↗ |
| Known as | Spedra | ChEMBL registry synonym — accepted as the source's own label CHEMBL1963681 ↗ |
| Known as | Stendra | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02033200 ↗ |
| Known as | TA-1790 | “A Phase I, Single-Centre, Open-Label, Randomized, One-sequence Crossover, Three-Group Study to Evaluate the Effect of Ketoconazole, Ritonavir and Erythromicin on the Safety and...” NCT00770042 ↗ |
| Action | Inhibit | “Avanafil is a potent and highly specific PDE5 inhibitor” NCT00770042 ↗1“Phosphodiesterase 5A inhibitor” CHEMBL1963681 ↗ |
| Modality | Small molecule | — CHEMBL1963681 ↗ |
| Route | Oral | “30 minutes orally prior to initiation of sexual activity” NCT00790751 ↗ |
| Target | PDE5A | “Phosphodiesterase 5A inhibitor” CHEMBL1963681 ↗ |