Sildenafil
targets CYP3A4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | REVATIO | — | 2009-05-07 – 2023-01-31 | fda.gov ↗ |
| Label expansion | US (FDA) | VIAGRA | — | 2002-09-19 | fda.gov ↗ |
| Approved | EU (EMA) | Viagra | — | 1998-09-13 | europa.eu ↗ |
| Approved | US (FDA) | VIAGRA | — | 1998-03-27 | fda.gov ↗ |
Trials 265 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 07 trials · 1 met primary | ||||||
| Phase 0 | NCT07039760 | Oct 2026 → Apr 2028 expected | brain neoplasm | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT05466695 | Aug 2022 → Jul 2023 | — | Assiut University | Unknown | No outcome recorded |
| Phase 0 | NCT06527729 | Jul 2021 → Jun 2022 | alopecia areata | Assiut University | Completed | No outcome recorded |
| Phase 0 | NCT03229512 | Apr 2017 → Jun 2020 | hand-foot syndrome | Northwestern University | Completed | No outcome recorded |
| Phase 0 | NCT02795351 | Jun 2015 → Feb 2021 | migraine with aura | Herlev Hospital | Completed | Met primary |
| Phase 0 | NCT01359670 | May 2011 → May 2013 | Duchenne muscular dystrophy | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT00815646 | Jan 2008 → Dec 2015 | high altitude pulmonary edema | Duke University | Completed | No outcome recorded |
| Phase 148 trials · 1 met primary | ||||||
| Phase 1 | NCT07508358 | Oct 2026 → Jun 2027 expected | dysmenorrhea, endometriosis, uterine corpus leiomyoma | Kevin Hellman | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07302698 | Mar → May 2026 overdue | — | Aspargo Labs, Inc | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07117383 | Jan → Mar 2026 overdue | erectile dysfunction | Aspargo Labs, Inc | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06289881 | Feb → Mar 2025 | — | Bio-innova Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT06782659 | Jan → Mar 2025 overdue | erectile dysfunction | Aspargo Labs, Inc | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06324396 | Mar 2024 → Dec 2026 expected | congenital cardiovascular shunt | Children's Mercy Hospital Kansas City | Recruiting | No outcome recorded |
| Phase 1 | NCT05684289 | Jan → May 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05275725 | Jul 2022 → Jan 2025 | perinatal asphyxia | Pia Wintermark | Completed | No outcome recorded |
| Phase 1 | NCT04283435 | Sep 2021 → Mar 2022 | — | Cairo University | Unknown | No outcome recorded |
| Phase 1 | NCT04211272 | Jan 2020 → Apr 2021 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT04169191 | Sep 2019 → Dec 2021 | perinatal asphyxia | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| Phase 1 | NCT04481789 | Oct → Dec 2018 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT03510338 | May → Jun 2018 | erectile dysfunction | N4 Pharma UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04994860 | Mar → Jun 2018 | pulmonary arterial hypertension | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT03417492 | Mar 2018 → Jun 2022 | traumatic brain injury, traumatic encephalopathy | University of Pennsylvania | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02975037 | Feb → Mar 2017 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03028298 | Dec 2016 → Dec 2022 | intracranial vasospasm, subarachnoid hemorrhage | University of Mississippi Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT02946944 | Oct 2016 → Oct 2020 | pulmonary embolism | Meshalkin Research Institute of Pathology of Circulation | Unknown | No outcome recorded |
| Phase 1 | NCT02466802 | Jul 2015 → Jan 2019 | neoplasm | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT01954524 | May 2014 → Oct 2015 | cirrhosis of liver | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02028598 | Jan → Mar 2014 | — | CTC Bio, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01986673 | Oct → Nov 2013 | — | Strategic Science & Technologies, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01950923 | Sep 2013 → Mar 2016 | kidney cancer | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02136329 | Jun 2013 → Dec 2014 | acute kidney injury | University of Leicester | Completed | No outcome recorded |
| Phase 1 | NCT01670136 | Feb 2013 → Jul 2016 | pulmonary hypertension, neonatal | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT01499498 | Dec 2012 → Apr 2013 | hepatitis C virus infection | Imperial College London | Completed | No outcome recorded |
| Phase 1 | NCT01656798 | Aug 2012 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02628847 | Mar 2012 → Oct 2016 | stroke disorder | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01580501 | Mar 2012 → Mar 2013 | Duchenne muscular dystrophy | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01651858 | Feb → Mar 2012 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT01514903 | Dec 2011 | erectile dysfunction | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT01769638 | Sep → Nov 2011 | — | Seoul Pharma Co., Ltd. | Completed | Met primary |
| Phase 1 | NCT01375699 | Aug 2011 → Aug 2017 | breast cancer, digestive system cancer, female reproductive organ cancer, sarcoma | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT01254396 | Dec 2010 → Jan 2011 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01254383 | Dec 2010 → Mar 2011 | erectile dysfunction | Viatris Inc. | Completed | Mixed |
| Phase 1 | NCT01244620 | Nov → Dec 2010 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT01219023 | Jun 2010 → Apr 2012 | hand-foot syndrome | Duke University | Completed | No outcome recorded |
| Phase 1 | NCT00904748 | Jan → Mar 2010 | erectile dysfunction | Viatris Inc. | Completed | Mixed |
| Phase 1 | NCT01027117 | Sep 2009 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00950404 | Aug → Sep 2009 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00795938 | Oct → Nov 2008 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00866463 | Oct 2008 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00814736 | Aug → Sep 2008 | erectile dysfunction, hyperplasia, overactive bladder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00767598 | Dec 2007 | — | Inje University | Completed | No outcome recorded |
| Phase 1 | NCT00452582 | Apr 2005 → ? | ischemic stroke | Henry Ford Health System | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00056433 | Mar 2003 → Dec 2006 | sickle cell disease | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT00175981 | Feb 2003 → Nov 2004 | — | Heidelberg University | Completed | No outcome recorded |
| Phase 1 | NCT00223717 | Jan 2001 → Jan 2017 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 1/213 trials · 1 met primary · 2 missed | ||||||
| Phase 1/2 | NCT04489446 | Aug 2020 → Apr 2021 | COVID-19 | Universidad Nacional Andres Bello | Completed | Missed primary |
| Phase 1/2 | NCT04100759 | Jun 2019 | erectile dysfunction | Ain Shams University | Completed | No outcome recorded |
| Phase 1/2 | NCT03259516 | May 2017 → Dec 2018 | myelodysplastic syndrome | St. Petersburg State Pavlov Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03012386 | Jan 2017 → Jul 2021 | — | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02626182 | Dec 2015 → Jan 2018 | cystic fibrosis | National Jewish Health | Completed | No outcome recorded |
| Phase 1/2 | NCT03192709 | Feb 2015 → Aug 2017 | female infertility | Royan Institute | Unknown | No outcome recorded |
| Phase 1/2 | NCT01853540 | Jan 2013 → Oct 2014 | pulmonary non-tuberculous mycobacterial infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT01194232 | Aug → Dec 2012 | cystic fibrosis | Children's Hospital Medical Center, Cincinnati | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02028429 | Jul 2012 → Nov 2013 | hepatic encephalopathy | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 1/2 | NCT01334554 | Apr 2011 → Aug 2013 | metabolic syndrome X, obesity disorder | Vanderbilt University Medical Center | Completed | Missed primary |
| Phase 1/2 | NCT01290484 | Dec 2010 → Apr 2013 | lymphangioma | Stanford University | Completed | No outcome recorded |
| Phase 1/2 | NCT00659529 | Aug 2008 → Aug 2012 | cystic fibrosis | National Jewish Health | Completed | No outcome recorded |
| Phase 1/2 | NCT00123162 | May 2007 → Jun 2011 | dysmenorrhea | Milton S. Hershey Medical Center | Completed | Met primary |
| Phase 251 trials · 1 met primary · 10 missed | ||||||
| Phase 2 | NCT07647003 | Oct 2026 → May 2027 expected | hypertensive disorder | NuSirt Biopharma | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06810284 | Oct 2026 → Jun 2027 expected | brain hypoxia - ischemia | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07290400 | Apr → Jun 2026 overdue | erectile dysfunction | Aspargo Labs, Inc | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05061368 | Mar 2022 → May 2027 expected | chronic obstructive pulmonary disease | University of Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT04797286 | Sep 2021 → Nov 2026 expected | pulmonary hypertension, scleroderma | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT04565925 | Jul 2021 → Dec 2026 expected | spinal cord injury | The University of Texas Medical Branch, Galveston | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04985929 | Jul 2021 → Jul 2024 | — | University of Alberta | Completed | No outcome recorded |
| Phase 2 | NCT04948151 | Jun → Dec 2021 | sexual disorder | Strategic Science & Technologies, LLC | Unknown | Missed primary |
| Phase 2 | NCT04058132 | Aug 2019 → Mar 2020 | traumatic brain injury | Uniformed Services University of the Health Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03855332 | Jul 2019 → Dec 2022 | cerebrovascular disorder | University of Oxford | Completed | Missed primary |
| Phase 2 | NCT03696758 | Oct 2018 → Feb 2020 | pulmonary immaturity | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 2 | NCT04718233 | Sep 2018 → Jul 2019 | pregnancy loss, recurrent, 4 | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT03142568 | Apr 2018 → Mar 2025 | bronchopulmonary dysplasia | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT03364335 | Jan → Aug 2018 | obesity disorder | NuSirt Biopharma | Completed | Met primary |
| Phase 2 | NCT02908490 | Apr 2017 → Jun 2020 | atherosclerosis, rheumatoid arthritis | Kimberly Liang | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT02951429 | Dec 2016 → Sep 2019 | idiopathic pulmonary fibrosis | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT02663830 | Jan 2016 → Jan 2017 | anovulation | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT02546609 | Nov 2015 → Nov 2016 | NAFLD1 | NuSirt Biopharma | Completed | Missed primary |
| Phase 2 | NCT02571101 | Nov 2015 → May 2016 | premature ejaculation | CTC Bio, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT01132482 | Oct 2015 → May 2017 | cystic fibrosis | National Jewish Health | Completed | No outcome recorded |
| Phase 2 | NCT02570282 | Sep 2015 → May 2017 | sexual disorder | Strategic Science & Technologies, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02335242 | May 2015 → Mar 2021 | lymphatic malformation | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT02244528 | Oct 2014 → Oct 2016 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02057458 | Apr 2014 → Jul 2018 | cystic fibrosis | Augusta University | Completed | No outcome recorded |
| Phase 2 | NCT01817751 | Apr 2013 → Aug 2020 | brain neoplasm, glioblastoma, grade III glioma | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT01830790 | Mar 2013 → May 2014 | age-related macular degeneration | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01762475 | Jan 2013 → Dec 2015 | traumatic brain injury, traumatic encephalopathy | Uniformed Services University of the Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01601470 | Sep 2012 → Jan 2013 | hypertensive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01360671 | Mar 2012 → Apr 2013 | pulmonary hypertension, neonatal | Viatris Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01481350 | Feb 2012 → Jun 2013 | pulmonary hypertension | University of Turin, Italy | Completed | No outcome recorded |
| Phase 2 | NCT01350154 | Nov 2011 → Apr 2013 | Becker muscular dystrophy | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT01432665 | Sep 2011 → May 2013 | hypoactive sexual desire disorder | Emotional Brain NY Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01409031 | Jul 2011 → Oct 2013 | pulmonary hypertension, respiratory failure | University of Colorado, Denver | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01069861 | Dec 2010 → Nov 2011 | pulmonary hypertension, neonatal, respiratory failure | Viatris Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01168908 | Sep 2010 → Jan 2014 | Becker muscular dystrophy, Duchenne muscular dystrophy | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Terminated | Missed primary |
| Phase 2 | NCT01091870 | Mar 2010 → Dec 2012 | brain aneurysm, intracranial vasospasm, subarachnoid hemorrhage | Hospital de Clinicas de Porto Alegre | Withdrawn | No outcome recorded |
| Phase 2 | NCT00914277 | May → Sep 2009 | erectile dysfunction | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00871065 | Jul 2008 → Feb 2009 | intracranial vasospasm, subarachnoid hemorrhage | University of Nebraska | Withdrawn | No outcome recorded |
| Phase 2 | NCT00940901 | Jun 2008 → Nov 2012 | priapism, sickle cell disease | Johns Hopkins University | Completed | Missed primary |
| Phase 2 | NCT00492531 | Jun 2007 → Sep 2009 | pulmonary hypertension, sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Terminated | Missed primary |
| Phase 2 | NCT00359736 | Jul 2006 → Oct 2008 | pulmonary fibrosis, pulmonary hypertension | VA Office of Research and Development | Completed | Missed primary |
| Phase 2 | NCT00273416 | Jan 2006 → ? | erectile dysfunction | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00165295 | Sep 2005 → Jun 2007 | Waldenstrom macroglobulinemia | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00352482 | Nov 2004 → Jul 2007 | idiopathic pulmonary fibrosis, pulmonary hypertension | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00141310 | Sep 2004 → Apr 2006 | preeclampsia | Viatris Inc. | Terminated | Missed primary |
| Phase 2 | NCT00640458 | Apr 2004 → Mar 2007 | sexual disorder | Viatris Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00317421 | Mar 2004 → Nov 2005 | hypertensive disorder | University of Edinburgh | Completed | No outcome recorded |
| Phase 2 | NCT00624273 | Feb → Nov 2004 | ulcer disease | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT00145938 | Sep 2003 → Sep 2006 | pulmonary hypertension | University of Chicago | Terminated | No outcome recorded |
| Phase 2 | NCT00746967 | Jan 2003 → Feb 2004 | psychosexual disorder | Viatris Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02162979 | Feb 2002 → Jan 2009 | Parkinson disease | Loma Linda University | Terminated | No outcome recorded |
| Phase 2/314 trials | ||||||
| Phase 2/3 | NCT06800092 | Jun 2027 → Jun 2030 expected | cancer | The University of Texas Medical Branch, Galveston | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07824674 | Sep 2026 → Apr 2028 expected | pulmonary arterial hypertension | Silvia Ulrich | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07462260 | Aug 2025 → Sep 2026 | pulmonary hypertension, rheumatic heart disease | Sindh Institute of Cardiovascular Diseases | Completed | No outcome recorded |
| Phase 2/3 | NCT05971667 | Jul → Oct 2023 | — | Beni-Suef University | Unknown | No outcome recorded |
| Phase 2/3 | NCT05951413 | Jun → Sep 2023 | — | Beni-Suef University | Unknown | No outcome recorded |
| Phase 2/3 | NCT05846906 | Oct 2021 → Apr 2022 | female infertility | Beni-Suef University | Completed | No outcome recorded |
| Phase 2/3 | NCT03763045 | Dec 2018 → Feb 2019 | pulmonary hypertension | Ain Shams University | Unknown | No outcome recorded |
| Phase 2/3 | NCT02782559 | Jul 2016 → Jul 2017 | preeclampsia | The University of Texas Health Science Center, Houston | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT02435303 | May 2016 → Jun 2018 | mitral valve disorder, pulmonary hypertension | Asan Medical Center | Terminated | No outcome recorded |
| Phase 2/3 | NCT02766725 | Jan → Nov 2015 | infertility disorder | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT02050360 | Nov 2013 → May 2015 | Raynaud disease | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 2/3 | NCT01936350 | Sep → Nov 2013 | heart failure | Hospital Ana Nery | Completed | No outcome recorded |
| Phase 2/3 | NCT00981747 | Sep 2009 → Dec 2016 | idiopathic pulmonary fibrosis, pulmonary fibrosis | Alicia Gerke | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT01107782 | Jun 2008 → Jun 2010 | fetal growth restriction | Tehran University of Medical Sciences | Unknown | No outcome recorded |
| Phase 333 trials · 2 met primary · 5 missed | ||||||
| Phase 3 | NCT05490680 | Jan → Dec 2024 | erectile dysfunction | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 3 | NCT03997097 | Jun 2023 → Jun 2026 | pulmonary hypertension, univentricular heart | University Hospital, Montpellier | Withdrawn | No outcome recorded |
| Phase 3 | NCT03686306 | Nov 2021 → Nov 2025 overdue | peripheral arterial disease | Rennes University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04304313 | Feb → Mar 2020 | COVID-19 | Tongji Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04052269 | Jun 2019 → Oct 2021 | glaucoma | Imperial College London | Suspended | No outcome recorded |
| Phase 3 | NCT03356353 | Mar 2018 → Sep 2021 | advanced heart failure | University of Calgary | Unknown | No outcome recorded |
| Phase 3 | NCT03154476 | Jul 2017 → Jun 2019 | cirrhosis of liver, congenital heart disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 3 | NCT03230162 | Jun 2017 → May 2018 | fetal growth restriction | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT03177824 | Mar → Sep 2017 | fetal growth restriction | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT02832570 | Nov 2016 → Oct 2017 | peripheral arterial occlusive disease 1 | University Hospital, Angers | Completed | Met primary |
| Phase 3 | NCT02590536 | Oct 2015 → Jun 2017 | fetal growth restriction | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT01913847 | Sep 2013 → Dec 2018 | pulmonary hypertension, systolic heart failure | Hanmi Pharmaceutical Company Limited | Unknown | No outcome recorded |
| Phase 3 | NCT01720524 | Aug 2013 → Oct 2018 | pulmonary hypertension, neonatal | Viatris Inc. | Completed | Missed primary |
| Phase 3 | NCT01091012 | Sep 2011 → Dec 2012 | pulmonary hypertension | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 3 | NCT01392469 | Apr 2011 → Oct 2012 | pulmonary arterial hypertension | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00796510 | Jul 2010 → Jan 2011 | pulmonary arterial hypertension | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00796666 | May 2009 → Mar 2011 | pulmonary arterial hypertension | Pfizer | Terminated | Missed primary |
| Phase 3 | NCT00763867 | Sep 2008 → Sep 2012 | diastolic heart failure | Duke University | Completed | Missed primary |
| Phase 3 | NCT00734604 | Aug 2008 → Sep 2009 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00742014 | Aug 2008 → Aug 2011 | hypertensive disorder | The Hospital for Sick Children | Terminated | No outcome recorded |
| Phase 3 | NCT00454207 | Apr 2007 → Feb 2009 | pulmonary arterial hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00303004 | Mar 2006 → Jan 2008 | Eisenmenger syndrome | Rigshospitalet, Denmark | Completed | Missed primary |
| Phase 3 | NCT00544076 | Jan 2006 → Apr 2012 | erectile dysfunction, grade III prostatic intraepithelial neoplasia | City of Hope Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00407446 | Jan 2004 → Feb 2005 | heart failure | University of Milan | Completed | No outcome recorded |
| Phase 3 | NCT00159874 | Jan 2004 → Dec 2012 | pulmonary arterial hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00159913 | Aug 2003 → Jun 2008 | pulmonary arterial hypertension | Viatris Inc. | Completed | Missed primary |
| Phase 3 | NCT00159861 | Jul 2003 → Jan 2006 | pulmonary hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00309790 | May 2003 → Mar 2006 | congestive heart failure | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00159887 | Dec 2002 → Feb 2007 | pulmonary arterial hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00309816 | Dec 2001 → Feb 2006 | congestive heart failure | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00527995 | Aug 2001 → Jun 2003 | type 2 diabetes mellitus | Ruhr University of Bochum | Completed | No outcome recorded |
| Phase 3 | NCT00420901 | Jan 1999 → Feb 2000 | diabetes mellitus | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 3 | NCT02930811 | ? → Oct 2022 | peripheral arterial occlusive disease 1 | University Hospital, Angers | Withdrawn | No outcome recorded |
| Phase 465 trials · 4 met primary · 5 missed | ||||||
| Phase 4 | NCT06875258 | Jan 2024 → Jan 2027 expected | — | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05183334 | Dec 2021 → Dec 2022 | premature ejaculation | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT05753098 | Jan 2021 → Jan 2023 | female infertility | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT04325243 | Sep 2020 → Apr 2022 | — | Assiut University | Completed | No outcome recorded |
| Phase 4 | NCT03382106 | Mar 2018 → Sep 2024 | pulmonary emphysema | Eric A. Hoffman | Completed | No outcome recorded |
| Phase 4 | NCT02682147 | Jul 2017 → May 2025 overdue | pulmonary emphysema | Eric A. Hoffman | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04908657 | Jul 2017 → Jul 2023 | fibrotic liver disease | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03044561 | Jan → Aug 2017 | infertility disorder | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT02939495 | Oct 2016 → Jun 2017 | erectile dysfunction, premature ejaculation | Neutec Ar-Ge San ve Tic A.Ş | Completed | No outcome recorded |
| Phase 4 | NCT02524184 | Aug 2015 → Sep 2016 | obesity disorder | Xiang Guang-da | Unknown | No outcome recorded |
| Phase 4 | NCT02378649 | Mar 2015 → Jun 2018 | pulmonary hypertension | Dr. Robert Klempfner Heart Rehabilitation Institute | Completed | No outcome recorded |
| Phase 4 | NCT02620995 | Oct 2014 → Jan 2018 | erectile dysfunction, hypertensive disorder | National Institute of Cardiology, Laranjeiras, Brazil | Completed | No outcome recorded |
| Phase 4 | NCT02060487 | Sep 2014 → Feb 2021 | pulmonary arterial hypertension | Viatris Inc. | Terminated | Met primary |
| Phase 4 | NCT02129725 | Apr 2014 → Oct 2016 | metabolic syndrome X | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03236818 | May 2013 → Sep 2017 | pulmonary arterial hypertension | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 4 | NCT01889966 | Apr 2013 → Jan 2015 | pulmonary hypertension | Kerckhoff Heart Center | Completed | No outcome recorded |
| Phase 4 | NCT01800292 | Feb → Dec 2013 | left ventricular failure, pulmonary arterial hypertension | University of Arizona | Completed | No outcome recorded |
| Phase 4 | NCT01642407 | Aug 2012 → May 2016 | pulmonary arterial hypertension | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00730067 | Jun → Dec 2012 | chronic obstructive pulmonary disease, pulmonary hypertension | University of Aarhus | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01419392 | Sep 2011 → Apr 2012 | habitual spontaneous abortion | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT01382368 | Sep 2011 → Nov 2012 | chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01409993 | Aug 2011 → Nov 2016 | glucose intolerance | Vanderbilt University | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03733470 | Jun 2011 → Jan 2014 | pulmonary emphysema | Eric A. Hoffman | Completed | No outcome recorded |
| Phase 4 | NCT01352507 | Jun 2011 → Jun 2012 | erectile dysfunction | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01060020 | Jan 2010 → Sep 2011 | aortic valve stenosis | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00937144 | Sep 2009 | sickle cell disease | The Baruch Padeh Medical Center, Poriya | Withdrawn | No outcome recorded |
| Phase 4 | NCT01668446 | Sep 2009 | endometrial disorder | farzaneh hojjat | Completed | No outcome recorded |
| Phase 4 | NCT00862043 | Apr 2009 → Jul 2016 | heart valve disorder, pulmonary hypertension | Hospital General Universitario Gregorio Marañon | Completed | Missed primary |
| Phase 4 | NCT00793338 | Nov 2008 → Nov 2010 | congestive heart failure | University of New Mexico | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01055405 | Aug 2008 → Mar 2011 | chronic obstructive pulmonary disease, pulmonary hypertension | Hospital Clinic of Barcelona | Completed | Missed primary |
| Phase 4 | NCT00430716 | Apr 2008 → May 2010 | pulmonary arterial hypertension | Viatris Inc. | Terminated | Mixed |
| Phase 4 | NCT00433329 | Mar 2007 → May 2010 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00625079 | Feb 2007 → Jun 2009 | idiopathic pulmonary fibrosis, pulmonary arterial hypertension | University of California, Los Angeles | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00781508 | Dec 2006 → Sep 2009 | left ventricular failure, symptomatic heart failure | MetroHealth Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00512707 | Nov 2006 → May 2010 | diabetes mellitus, erectile dysfunction, hypogonadism | Boston University | Completed | Missed primary |
| Phase 4 | NCT00323297 | Sep 2006 → Aug 2013 | pulmonary arterial hypertension | Viatris Inc. | Completed | Missed primary |
| Phase 4 | NCT00347867 | Jul 2006 → ? | fetal growth restriction | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 4 | NCT00343200 | Jul 2006 → Sep 2007 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00350441 | Jun 2006 → ? | — | NHS Greater Glasgow Yorkhill Division | Unknown | No outcome recorded |
| Phase 4 | NCT00133679 | Feb 2006 → Jul 2013 | diaphragm disorder, pulmonary hypertension, pulmonary hypoplasia | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 4 | NCT00455715 | Feb 2006 → Sep 2007 | schizophrenia | Massachusetts General Hospital | Completed | Missed primary |
| Phase 4 | NCT00147628 | Nov 2005 → Sep 2006 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00301262 | Nov 2005 → Sep 2007 | erectile dysfunction | Viatris Inc. | Completed | Met primary |
| Phase 4 | NCT00245258 | Nov 2005 → Sep 2006 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00249730 | Oct 2005 → ? | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00245596 | Oct 2005 → ? | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00313898 | Sep 2005 → Jun 2007 | erectile dysfunction | Rambam Health Care Campus | Unknown | No outcome recorded |
| Phase 4 | NCT00143260 | Aug 2005 → May 2006 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00159900 | May 2005 → Jan 2006 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00137072 | Apr 2005 → Feb 2006 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00150358 | Mar → Nov 2005 | erectile dysfunction, hypertensive disorder | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00151463 | Jan 2005 → ? | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00194909 | Aug 2004 → Jul 2006 | diabetic neuropathy | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT00194597 | Jul 2004 → Jul 2007 | prostatitis | University of Washington | Terminated | No outcome recorded |
| Phase 4 | NCT00159809 | Mar → Aug 2004 | depressive disorder, erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00143221 | Mar 2004 → May 2005 | erectile dysfunction | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00479908 | Jan 2004 → Sep 2005 | intermediate coronary syndrome | University of Edinburgh | Completed | No outcome recorded |
| Phase 4 | NCT01941732 | Nov 2003 → Feb 2004 | Parkinson disease, erectile dysfunction | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00483626 | Aug 2003 → Jun 2007 | pulmonary arterial hypertension | University of Chile | Unknown | No outcome recorded |
| Phase 4 | NCT00627965 | Mar 2003 → Feb 2008 | acute mountain sickness, high altitude pulmonary edema | Altitude Physiology Expeditions | Completed | No outcome recorded |
| Phase 4 | NCT00645268 | Dec 2002 → Jan 2004 | erectile dysfunction, type 2 diabetes mellitus | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00598585 | Jul 2002 → Dec 2010 | myalgic encephalomeyelitis/chronic fatigue syndrome | Charles Drew University of Medicine and Science | Completed | Met primary |
| Phase 4 | NCT00145483 | Jun 2002 → Nov 2006 | Meniere disease | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00251784 | Feb 2002 → Jun 2003 | blindness (disorder) | University of Cambridge | Completed | No outcome recorded |
| Phase 4 | NCT00375297 | Jan 2001 → Jun 2005 | depressive disorder, sexual disorder | University of New Mexico | Completed | No outcome recorded |
| Phase not applicable31 trials · 4 met primary | ||||||
| — | NCT04912726 | Jan 2025 → Jun 2026 | pulmonary hypertension, neonatal | Universidad del Norte | Withdrawn | No outcome recorded |
| — | NCT06237751 | Feb → Oct 2024 | — | First People's Hospital of Chenzhou | Unknown | No outcome recorded |
| — | NCT06562036 | Dec 2023 → May 2024 | pulmonary hypertension, neonatal | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT05889455 | Apr → Oct 2023 | migraine without aura | Danish Headache Center | Completed | No outcome recorded |
| — | NCT05669885 | Jan → Dec 2023 | traumatic encephalopathy | Danish Headache Center | Unknown | Met primary |
| — | NCT05369481 | Mar → Aug 2022 | androgenetic alopecia | Mohammed Abd El Mawgoud Amer | Unknown | No outcome recorded |
| — | NCT04122105 | Apr 2021 → Jan 2023 | — | University of British Columbia | Withdrawn | No outcome recorded |
| — | NCT04344678 | Jan 2020 → Oct 2024 | major depressive disorder | Sadat City University | Withdrawn | No outcome recorded Stop: Business |
| — | NCT04170790 | Dec 2019 | erectile dysfunction, type 2 diabetes mellitus | Ain Shams University | Unknown | No outcome recorded |
| — | NCT04126252 | Aug 2018 → Sep 2019 | erectile dysfunction | International Islamic University, Islamabad | Completed | No outcome recorded |
| — | NCT03301233 | Nov 2017 → Jul 2018 | — | Ain Shams University | Completed | No outcome recorded |
| — | NCT03185364 | Jun 2017 → Dec 2020 | chronic obstructive pulmonary disease, pulmonary hypertension | Chinese Academy of Medical Sciences, Fuwai Hospital | Unknown | No outcome recorded |
| — | NCT03143465 | Aug 2016 → Dec 2018 | migraine with aura | Danish Headache Center | Unknown | No outcome recorded |
| — | NCT01572363 | Apr 2012 → Mar 2014 | congenital heart disease | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| — | NCT01548950 | Sep 2011 → Jan 2014 | congenital heart disease, pulmonary arterial hypertension | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| — | NCT01373749 | Mar → Dec 2011 | pulmonary hypertension, neonatal | Third Military Medical University | Unknown | No outcome recorded |
| — | NCT01812434 | Oct 2010 → Mar 2015 | — | University of Minnesota | Withdrawn | No outcome recorded |
| — | NCT01059994 | Jan 2010 → Jul 2013 | — | The University of Texas Medical Branch, Galveston | Completed | Met primary |
| — | NCT00955929 | Aug 2009 → Dec 2020 | erectile dysfunction, penile cancer | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01948518 | Jun 2009 → Jun 2012 | interstitial lung disease, pulmonary hypertension | The Cleveland Clinic | Completed | No outcome recorded |
| — | NCT01391104 | Apr 2009 → Nov 2011 | pulmonary arterial hypertension | Laval University | Completed | No outcome recorded |
| — | NCT00772135 | Sep 2008 → Feb 2009 | congenital heart disease | Oslo University Hospital | Unknown | No outcome recorded |
| — | NCT00710099 | Jul 2008 → Jun 2011 | — | University Hospital, Grenoble | Completed | No outcome recorded |
| — | NCT00685945 | Dec 2007 → Jan 2009 | obesity disorder | Vanderbilt University | Completed | Met primary |
| — | NCT00507286 | May 2007 → Sep 2008 | erectile dysfunction | Keogh Institute for Medical Research | Unknown | No outcome recorded |
| — | NCT00478335 | May 2007 → Oct 2012 | nephrogenic diabetes insipidus | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00599235 | Mar 2007 → May 2008 | hypertensive disorder | University of Edinburgh | Completed | No outcome recorded |
| — | NCT00463957 | Aug 2006 → ? | erectile dysfunction | University of Cambridge | Unknown | No outcome recorded |
| — | NCT00297544 | Oct 2005 → ? | erectile dysfunction | Rambam Health Care Campus | Unknown | No outcome recorded |
| — | NCT00057759 | Jan 2003 → Dec 2006 | erectile dysfunction, prostate cancer, radiation-induced disorder | Radiation Therapy Oncology Group | Completed | Met primary |
| — | NCT00155714 | Nov 2002 → May 2005 | pulmonary hypertension | National Taiwan University Hospital | Withdrawn | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT01582438 | — | pulmonary arterial hypertension | Viatris Inc. | No longer available | No outcome recorded |
| — | NCT01897740 | — | pulmonary arterial hypertension | Viatris Inc. | No longer available | No outcome recorded |
| — | NCT00866983 | — | pulmonary arterial hypertension | Viatris Inc. | No longer available | No outcome recorded |
| Comparator or background therapy152 trials | ||||||
| Phase 0 | NCT06510322 Comparator | Mar 2025 → Dec 2029 expected | vascular disorder | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 0 | NCT04770155 Comparator | May → Sep 2021 | vascular insufficiency disorder | University of Mississippi Medical Center | Terminated | No outcome recorded |
| Phase 0 | NCT03945643 Comparator | Jul 2019 → Jan 2023 | congenital arteriovenous fistula, patent foramen ovale | University of Oregon | Completed | No outcome recorded |
| Phase 0 | NCT03199612 Comparator | Jun 2019 → Jan 2023 | hemolytic anemia, thrombotic disease | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT03027674 Comparator | Aug 2016 | Raynaud disease, dermatomyositis, systemic lupus erythematosus, systemic sclerosis | Pontificia Universidad Catolica de Chile | Completed | No outcome recorded |
| Show all 152 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Daré Bioscience, Inc. | Results Press Release: Daré Bioscience Announces Peer-Reviewed Publication of Phase 1 Sildenafil Cream Study in Men Demonstrating Substantially Lower Systemic Exposure Versus Oral Sildenafil darebioscience.com ↗
Topical dosing is targeted and has been shown to result in substantially lower systemic exposure than an oral dose of sildenafil. |
| 2026-08-26 | Daré Bioscience, Inc. | Results Press Release: Daré Bioscience’s Sildenafil Cream Data in Postmenopausal Women Published in Menopause – The Journal of The Menopause Society darebioscience.com ↗ |
| 2026-03-10 | Aspargo Labs, Inc | Regulatory Aspargo Labs Gears Up to Bring Patented Liquid Erectile Dysfunction Treatment to UK Over-the-Counter Pharmacy Shelves aspargolabs.com ↗
today announced it has submitted an application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) seeking approval of a smaller pack size |
| 2026-02-05 | IBSA Institut Biochimique SA | Regulatory IBSA Expands Solutions in Male Sexual Health in the US with New FDA Approval ibsagroup.com ↗
The Food and Drug Administration (FDA) approval has been granted for sildenafil oral film . |
| 2024-12-10 | Strategic Science & Technologies, LLC | Results Daré Bioscience Announces Publication in Sexual Medicine of Positive Findings from Demographic, Behavioral and Medication Use Subgroup Analyses in the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6% strategicscience.com ↗
We were pleased to see that age and race did not significantly impact response to Sildenafil Cream. |
| 2024-08-26 | Strategic Science & Technologies, LLC | Results Daré Bioscience Announces Publication in The Journal of Sexual Medicine of Positive Safety Findings from the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6% strategicscience.com ↗
Published data show that topical Sildenafil Cream, 3.6% was safe and well tolerated by women and their partners across 1,357 sexual experiences. |
| 2024-08-13 | Strategic Science & Technologies, LLC | Results Daré Bioscience Announces Publication in The Journal of Sexual Medicine of Positive Findings from the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6% strategicscience.com ↗
Published data show that responses from 1-month and 24-hour recall patient reported outcome (PRO) instruments were similar and support that either method could be used to assess treatment efficacy in future clinical studies |
| 2024-06-30 | Aspargo Labs, Inc | Results Aspargo Labs Announces Data on First Oral Spray for Erectile Dysfunction, ASP-001, Showing Two Times Faster Absorption Compared to Viagra® Tablets aspargolabs.com ↗
today announced the release of a Phase 1 study demonstrating that ASP-001, an investigative sildenafil oral spray in development for erectile dysfunction (ED), achieves absorption starting within five minutes, twice as fast as traditional sildenafil tablets. |
| 2024-06-24 | Strategic Science & Technologies, LLC | Results Daré Bioscience Announces Publication in Obstetrics & Gynecology of Phase 2b Study Efficacy Results of Topical Sildenafil Cream, 3.6% for the Treatment of Female Sexual Arousal Disorder strategicscience.com ↗
Topical Sildenafil Cream improved outcomes among women with FSAD, most significantly in a subset of women both with and without concomitant decreased desire. |
| 2024-03-07 | Strategic Science & Technologies, LLC | Results Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder strategicscience.com ↗ |
| 2023-09-05 | Aspargo Labs, Inc | Regulatory Aspargo Laboratories Announces IND Clearance by U.S. FDA, Enabling Launch of Bioequivalence and Food-Effect Studies for Sildenafil Oral Spray aspargolabs.com ↗
We are thrilled to have received IND clearance from the FDA for Sildenafil Oral Spray for the treatment of ED. |
| 2023-08-01 | Aspargo Labs, Inc | Regulatory Aspargo Laboratories, Inc. Announces Filing of Its Investigational New Drug Application For Sildenafil Oral Spray aspargolabs.com ↗ |
| 2023-01-24 | Aspargo Labs, Inc | Regulatory Aspargo Receives Regulatory Approval to Market Sildenafil Spray in Germany, Ireland, and The Netherlands aspargolabs.com ↗
Aspargo Laboratories, Inc. (“Aspargo”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that the German Federal Institute for Drugs and Medical Devices has authorized the marketability of “Hezkue™ 12.5 mg per actuation, oral suspension“ in Germany effective as of January 12, 2023. |
| 2022-10-01 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Sildenafil for Oral Suspension zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), has received final approval from the United States Food and Drug Administration (USFDA) to market Sildenafil for Oral Suspension USP 10 mg/ml USRLD: Revatio. |
| 2022-03-24 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Sildenafil for Oral Suspension lupin.com ↗ |
| 2022-02-02 | Lexaria Bioscience Corp. | Results Lexaria Reports Potentially Ground-Breaking Findings in Sildenafil Animal Study lexariabioscience.com ↗
In as little as four minutes after dosing, the DehydraTECH formulation delivered 74% more sildenafil into the bloodstream on average than the concentration-matched, generic control formulation. |
| 2019-12-02 | Impax Laboratories, LLC | Regulatory Amneal Announces the Approval and Launch of Generic Revatio® for Oral Suspension and Generic Amicar® Tablets amneal.com ↗
today announced that it has received final U.S. Food and Drug Administration (“FDA”) approval on its Abbreviated New Drug Applications (“ANDA”) for generic versions of Revatio® (sildenafil citrate) for Oral Suspension 10 mg/ml and Amicar® (aminocaproic acid) Tablets USP, 500 mg. |
| 2019-08-26 | Dicot AB | Results Resultat från jämförande djurförsöksstudie på effekterna av dess kandidatämne Libiguin® DIC2024 kontra den aktiva substansen i Viagra® dicotpharma.com ↗
Både DIC2024 och sildenafil gav en påtaglig stimulering av parningsbeteendet hos försöksdjuren, men resultaten visade också på tydliga skillnader i beteendemönstret, vilket visar att verkningsmekanismerna för preparaten skiljer sig markant. |
| 2019-06-28 | Pfizer | Results Pfizer Announces Results from Phase 3 Trial of Revatio® (Sildenafil Citrate) in Newborns with Persistent Pulmonary Hypertension pfizer.com ↗
Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. |
| 2019-06-17 | Strategic Science & Technologies, LLC | Results Daré Bioscience, Inc. Announces Positive Results in Thermography Feasibility Study with Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual Arousal Disorder strategicscience.com ↗
Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced positive findings from an investigational study designed to evaluate the feasibility of using thermography technology to assess the pharmacodynamics of Sildenafil Cream, 3.6% (Sildenafil Cream) in normal healthy women. |
| 2019-03-25 | Lupin Limited | Regulatory Lupin receives FDA approval for Sildenafil Tablets USP lupin.com ↗
Lupin Limited (Lupin) announced that it has received approval for its Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Pfizer Inc’s Viagra Tablets, 25 mg, 50 mg, and 100 mg. |
| 2015-11-05 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the U.S. Food and Drug Administration ( FDA ) has approved Genvoya ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. |
| 2015-05-15 | Strategic Science & Technologies, LLC | Results Strategic Science & Technologies, LLC (SST) announces completion of its Phase 1 clinical trial for SST-6007, a first-in-class topical sildenafil cream, to treat female sexual arousal disorder ------------------------------------------------ • SST-6007 was well tolerated in healthy subjects, with no dermal irritation observed at clinically relevant doses • SST-6007 successfully delivered sildenafil to the local target tissue • SST-6007 was systemically absorbed into the bloodstream, but at significantly reduced levels compared to the marketed oral formulation of sildenafil (Viagra®) ------------------------------------------------ strategicscience.com ↗
SST-6007 was well tolerated in healthy subjects, with no dermal irritation observed at clinically relevant doses |
| 2007-08-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Sildenafil Citrate Tablets, 20 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sildenafil Citrate Tablets, 20 mg. |
All press releases naming this drug 50 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 423 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sildenafil | “Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED)...” NCT01063855 ↗373“All patients will receive standard of care double oral background treatment consisting of one Phosphodiesterase type 5 inhibitor (i.e., tadalafil or sildenafil) and one...” NCT06317805 ↗ “This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra...” NCT01514903 ↗ “A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in...” NCT06782659 ↗ “The objective of this study was to evaluate the effects of a triple combination of leucine, metformin, and sildenafil (NS-0200) on body weight and obesity comorbidities in a...” PMID 30569637 ↗ Jan 2019 “patients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation.” NCT05741229 ↗ “Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.” NCT01069861 ↗ “The PDE-5 inhibitor, sildenafil, is approved for use in patients with PAH and commonly used in the initial treatment for PAH.” NCT01409122 ↗ “Sildenafil (REVATIO®) was approved for the treatment of adult Pulmonary Arterial Hypertension (PAH) in the US and the EU.” PMID 31538282 ↗ Sep 2019 “two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin” NCT03364335 ↗ “Sildenafil is an effective treatment for male penile erectile dysfunction that inhibits the breakdown cGMP.” NCT00479908 ↗ |
| Known as | ASP-001 | “A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in...” NCT06782659 ↗ |
| Known as | Hezkue | “Hezkue® oral sildenafil suspension will be administered as a single oral dose following controlled moderate alcohol consumption under fasting or standardized conditions,...” NCT07302698 ↗2“A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in...” NCT06782659 ↗ “Hezkue® sildenafil oral suspension will be administered as a single oral dose in each study period under different alcohol intake conditions” NCT07290400 ↗ |
| Known as | Respatio | “Sildenafil citrate (trade name: Revatio, Viagra, Respatio, etc.) was emerged as a drug helping vasodilation” NCT06565728 ↗ |
| Known as | Respatio(R) | “Includes 45 women who received Sildenafil citrate (Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period) and folic acid...” NCT03766594 ↗ |
| Known as | Revatio | “Sildenafil, commonly known as Revatio or Viagra, is a medication that increases the supply of blood to the lungs and reduces the workload of the heart.” NCT00763867 ↗8“Sildenafil (REVATIO®) was approved for the treatment of adult Pulmonary Arterial Hypertension (PAH) in the US and the EU.” PMID 31538282 ↗ Sep 2019 “Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)” NCT01517854 ↗ “Sildenafil citrate (trade name: Revatio, Viagra, Respatio, etc.) was emerged as a drug helping vasodilation” NCT06565728 ↗ “the drug sildenafil (Revatio®) can improve muscular, cardiac, cerebrovascular or cognitive function” NCT01350154 ↗ “Sildenafil (Revatio®) an inhibitor of the phosphodiesterase 5 (PDE-5)” NCT00586794 ↗ “Active Drug: Sildenafil tablets (Revatio)” NCT02335242 ↗ “sildenafil (Revatio) 20 mg TID” NCT00866983 ↗ |
| Known as | Revation | “Sildenafil (Revation) 20 mg” NCT01350154 ↗ |
| Known as | silden | “sildenafil (silden® 25, E.I.P.I.CO.)” NCT03301233 ↗ |
| Known as | Sildenafil Citrate | “A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female...” NCT00644631 ↗85“A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil...” NCT00249730 ↗ “A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Viagra...” NCT00644956 ↗ “Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the...” NCT01315262 ↗ “A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile...” NCT00645268 ↗ “An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With...” NCT00245596 ↗ “An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra...” NCT00151463 ↗ “One hour before each study part, a pharmacy produced capsule (envelope coded and drawn in a random manner from a box) containing either sildenafil citrate 50 mg or placebo will...” NCT00772135 ↗ “Sildenafil citrate is a phosphodiesterase-5 (PDE-5) inhibitor that is FDA-approved and widely used as a therapy for primary pulmonary hypertension and erectile dysfunction.” NCT05782244 ↗ “The phosphodiesterase 5 inhibitor, sildenafil citrate, slightly reduces systolic and diastolic blood pressures in treated hypertensives patients.” NCT01392638 ↗ “Among premature infants with severe BPD, enteral sildenafil citrate did not increase the incidence of hypotension or retinopathy of prematurity.” PMID 42105936 ↗ May 2026 |
| Known as | Sildenafil Citrate 20 mg ( Respatio 20 mg) | “Sildenafil Citrate 20 mg ( Respatio® 20 mg)” NCT03262961 ↗ |
| Known as | SST-6006 | “5% Sildenafil Cream (SST-6006)” NCT01986673 ↗ |
| Known as | SST-6007 | “SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate” NCT02570282 ↗ |
| Known as | UK-92,480 | “sildenafil citrate (UK-92,480)” NCT00454207 ↗ |
| Known as | Viagra | “The same brand of sildenafil citrate (VIAGRA, manufactured by Fareva Amboise Zone Industrielle, 29 route des Industries, 37530 Poce Sur Cisse, France, under authority of Pfizer...” NCT05558176 ↗48“A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female...” NCT00644631 ↗ “A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Viagra...” NCT00644956 ↗ “Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the...” NCT01315262 ↗ “Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury associated with cardiopulmonary bypass in children undergoing corrective surgical repair...” NCT00350441 ↗ “A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile...” NCT00645268 ↗ “An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With...” NCT00245596 ↗ “A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 Mg of HEZKUE® (ASP-001, Sildenafil) Versus 100 Mg of VIAGRA® (Sildenafil) Film-Coated Tablets Under Fasted Conditions in...” NCT06782659 ↗ “An Open-Label, Non-Comparative Study To Evaluate Treatment Responsiveness To The Quality Of Erection Questionnaire (QEQ) In Men With Erectile Dysfunction Treated With Viagra...” NCT00151463 ↗ “In 40 of the 80 subjects during the smoking cessation program, we will provide three times per day Sildenafil 20 milligrams (MG) (Viagra) for the full 3 months of the smoking...” NCT03382106 ↗ “To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify...” NCT00343200 ↗ |
| Known as | Viagra(R) | “Sildenafil (Viagra(R))is widely used by men with Parkinsons Disease (PD) and erectile dysfunction.” NCT01941732 ↗ |
| Action | Inhibit | “sildenafil (Viagra, a phosphodiesterase inhibitor that potentates cGMP dependent signaling)” NCT00056433 ↗ |
| Route | Oral | “oral L-arginine (the substrate for NO synthase) and sildenafil (Viagra, a phosphodiesterase inhibitor that potentates cGMP dependent signaling) will be added” NCT00056433 ↗ |
| Target | CYP3A4 | “sildenafil a CYP3A4 substrate and inhibitor” NCT04170790 ↗ |