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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT01095588 | Apr → May 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01117038 | Apr → May 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01095601 | Apr → May 2010 | — | 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 · 1 met primary | ||||||
| Phase 2 | NCT02477436 | Feb → Sep 2008 | erectile dysfunction | Pusan National University Hospital | Completed | Met primary |
| Phase 36 trials · 3 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT00853606 | Mar 2009 → Apr 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 3 | NCT00903981 | Mar → Oct 2009 | erectile dysfunction | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00809471 | Dec 2008 → Feb 2010 | erectile dysfunction | VIVUS LLC | Completed | Met primary |
| Phase 3 | NCT00790751 | Nov 2008 → Aug 2009 | erectile dysfunction | VIVUS LLC | Completed | Met primary |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT02033200 | Jan 2014 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 4 | NCT01768676 | Dec 2012 → Aug 2014 | erectile dysfunction | VIVUS LLC | Completed | Met primary |
| Phase 4 | NCT01698684 | Sep 2012 → Apr 2013 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT01054859 Comparator | Jan 2010 | erectile dysfunction | VIVUS LLC | Completed | No outcome recorded |
| Phase 3 | NCT01705197 Comparator | Feb 2012 → Apr 2013 | erectile dysfunction | JW Pharmaceutical | Completed | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2019-03-14 | VIVUS LLC | Regulatory VIVUS Announces Marketing Approval of Avanafil in the Russian Federation for the Treatment of Erectile Dysfunction vivus.com ↗
VIVUS, Inc. (Nasdaq: VVUS; the “Company”), a biopharmaceutical company, today announced that the Ministry of Health of the Russian Federation has approved 50 mg, 100 mg and 200 mg tablets of avanafil for the treatment of erectile dysfunction (ED). |
| 2012-05-07 | Tanabe Pharma Corporation | Regulatory VIVUS gains NDA approval for TA-1790 in the US tanabe-pharma.com ↗
VIVUS (head office: Mountain View, Californi a, U.S.) announced on April 27, 2012, that the company obtained NDA approval in the United States for TA -1790 (generic name: avanafil), a phosphodiesterase type5 (PDE5) inhibitor, which the company has developed as a treatment of erectile dysfunction (ED). |
| 2009-03-06 | JW Pharmaceutical | Regulatory [JW중외제약] 발기부전치료제 3상 승인 jw-pharma.co.kr ↗
중외제약(대표 이경하)은 발기부전치료제(PDE-5 억제제) <아바나필(Avanafil)>의 3상에 대한 임상시험 계획을 식약청으로부터 승인 받았다고 13일 밝혔다. |
| 2007-11-30 | JW Pharmaceutical | Regulatory 중외제약, 발기부전치료제 2차 임상 승인 jw-pharma.co.kr ↗
중외제약(대표 이경하)은 발기부전치료제(PDE-5 억제제)인 아바나필(Avanafil)에 대한 2상 임상시험을 식약청으로부터 승인 받았다고 30일 밝혔다. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-14 | VIVUS LLC | VIVUS Announces Marketing Approval of Avanafil in the Russian Federation for the Treatment of Erectile Dysfunction vivus.com ↗ |
| 2017-03-27 | VIVUS LLC | VIVUS Inc. Reacquires STENDRA Avanafil Commercial Rights from Sanofi vivus.com ↗ |
| 2013-07-09 | Menarini Group | Mountain view, calif., July 9, 2013 - Vivus announces avanafil partnership with Menarini menarini.com ↗ |
| 2012-05-07 | Tanabe Pharma Corporation | VIVUS gains NDA approval for TA-1790 in the US tanabe-pharma.com ↗ |
| 2009-03-06 | JW Pharmaceutical | [JW중외제약] 발기부전치료제 3상 승인 jw-pharma.co.kr ↗ |
| 2007-11-30 | JW Pharmaceutical | 중외제약, 발기부전치료제 2차 임상 승인 jw-pharma.co.kr ↗ |
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 NCT01095601 ↗ |
| 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 ↗ |