sildenafil
Trade name: viagra
Small moleculeapproved
Approved
Mar 27, 1998
Sildenafil (Viagra, Revatio) is a PDE5 inhibitor which was approved by FDA for the treatment of erectile disfunction and adults with pulmonary arterial hypertension. Upon administration sildenafil inhibits PDE5 and results in elevated level of cyclic guanosine monophosphate and smooth muscle relaxation. — NCATS
Clinical trial activity
409 trials · 286 clinical orgs · 43 marketing orgs
Phase 1
93
Phase 2
152
Phase 3
80
Phase 4
102
Earliest trial started Jan 1, 1999 (NCT00420901)
Timeline
1990s
2000s
- Jan 1, 2001
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
- Jun 3, 2005
Pfizer — First NDA Organization
- Jun 3, 2005
Pfizer — NDA Organization
- Nov 18, 2009
Meda Pharmaceuticals — NDA Secondary Org
2010s
- Apr 25, 2011
Apotex — Marketing Organization
- Sep 26, 2012
Dr. Reddy's Laboratories — Marketing Organization
- Nov 6, 2012
Chartwell Pharmaceuticals — Marketing Organization
- Nov 6, 2012
Changchun Changsheng Life Science and Technology Co., Ltd. — Marketing Organization
- Nov 6, 2012
Torrent Pharmaceuticals Limited — Marketing Organization
- Nov 6, 2012
Watson Pharmaceuticals — Marketing Organization
- Nov 6, 2012
Yiling Pharmaceutical Inc. — Marketing Organization
- Nov 9, 2012
Mylan — Marketing Organization
- Jan 7, 2013
Teva — Marketing Organization
- Feb 25, 2013
Actavis — Marketing Organization
- Feb 28, 2013
Amneal Pharmaceuticals — Marketing Organization
- Dec 17, 2013
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Dec 17, 2013
Neogen — Marketing Organization
- Nov 26, 2014
Hetero Labs Ltd — Marketing Organization
- Apr 1, 2015
Aurobindo Pharma — Marketing Organization
- Apr 1, 2015
Eugia Pharma — Marketing Organization
- Jun 20, 2016
Rubicon Research — Marketing Organization
- Aug 7, 2017
Appco Pharma — Marketing Organization
- May 4, 2018
Ajanta Pharma Ltd — Marketing Organization
- Mar 22, 2019
Lupin — Marketing Organization
- May 31, 2019
Novitium Pharma — Marketing Organization
- Jul 12, 2019
Alkem Labs Ltd — Marketing Organization
2020s
- Apr 23, 2020
Perrigo — Marketing Organization
- Jun 11, 2020
Sunshine Lake Pharma Co., Ltd. — Marketing Organization
- Jun 12, 2020
Reyoung Pharma Co Ltd — Marketing Organization
- Aug 6, 2020
Aptapharma Inc — Marketing Organization
- Aug 6, 2020
Invagen Pharms — Marketing Organization
- Aug 25, 2020
Umedica Labs Pvt Ltd — Marketing Organization
- Nov 25, 2020
AbbVie — Marketing Organization
- Nov 16, 2021
Taro Pharmaceuticals — Marketing Organization
- Nov 16, 2021
Sun Pharmaceuticals — Marketing Organization
- Nov 17, 2021
Tris Pharma, Inc. — Marketing Organization
- Feb 8, 2022
MSN Laboratories — Marketing Organization
- Sep 29, 2022
Zydus Discovery DMCC — Marketing Organization
- Apr 28, 2023
CMP Therapeutics Ltd — Marketing Organization
- Apr 28, 2023
CMP Therapeutics Ltd — NDA Secondary Org
- Nov 28, 2023
Cadila Healthcare — Marketing Organization
- Dec 1, 2023
Granules India — Marketing Organization
- Dec 20, 2024
Jubilant Innovation Ltd. — Marketing Organization
- Dec 16, 2025
IBSA Institut Biochimique SA — Marketing Organization
Indications
Approved for
Studied for
- Abortion, Habitual · Phase 4
- Acute Febrile Encephalopathy · Phase 2
- Acute Kidney Injury · Phase 1
- Alopecia Areata · Early Phase 1
- Altitude Sickness · Phase 4
- Anemia, Sickle Cell · Phase 4
- Aneurysm · Phase 2
- Angina Pectoris · Phase 4
- Anticoagulants · Phase 1
- Aortic Valve Stenosis · Phase 4
- Arterial Occlusive Diseases · Phase 3
- Arteriovenous Anastomosis · Early Phase 1
- Arthritis, Rheumatoid · Phase 2
- Asphyxia · Phase 2
- Atherosclerosis · Phase 2
- Bacterial Infections · Phase 1/Phase 2
- beta-Thalassemia · Phase 3
- Blindness · Phase 4
- Blood Pressure · Phase 2
- Brain Concussion · Phase 2
- Brain Injuries, Traumatic · Phase 2
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 1
- Bronchopulmonary Dysplasia · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2/Phase 3
- Cardiopulmonary Bypass · Phase 4
- Cardiovascular Diseases · Phase 2/Phase 3
- Central Serous Chorioretinopathy · Phase 2
- Cerebrovascular Disorders · Phase 2
- Child Development · Phase 2
- Cholangiocarcinoma · Phase 1
- Coronary Artery Disease · Phase 1
- Coronary Vasospasm · Phase 3
- COVID-19 · Phase 3
- Cystic Fibrosis · Phase 2/Phase 3
- Delivery, Obstetric · Phase 2
- Depression · Phase 4
- Dermatology · Early Phase 1
- Dermatomyositis · Early Phase 1
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Neuropathies · Phase 4
- Diving · Phase 2
- Drugs, Investigational · Phase 2/Phase 3
- Dysmenorrhea · Phase 1/Phase 2
- Edema · Early Phase 1
- Eisenmenger Complex · Phase 3
- Emphysema · Phase 4
- Endometrium · Phase 4
- Endothelial Cells · Phase 4
- Ethnic and Racial Minorities · Early Phase 1
- Fatigue Syndrome, Chronic · Phase 4
- Fertilization in Vitro · Phase 4
- Fetal Development · Phase 4
- Fetal Distress · Phase 4
- Fetal Growth Retardation · Phase 3
- Fibrosis · Phase 1
- Fontan Procedure · Phase 4
- Foramen Ovale, Patent · Early Phase 1
- Gastrointestinal Neoplasms · Phase 1
- General Surgery · Phase 4
- Genetic Diseases, Inborn · Phase 1
- Genital Neoplasms, Female · Phase 1
- Glaucoma · Phase 3
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Glucose Intolerance · Phase 4
- Growth and Development · Phase 3
- Hand-Foot Syndrome · Phase 1
- Healthy Volunteers · Phase 4
- Heart Defects, Congenital · Early Phase 1
- Heart Diseases · Phase 1
- Heart Failure · Phase 4
- Heart Failure, Diastolic · Phase 4
- Heart Valve Diseases · Phase 4
- Heart Ventricles · Phase 3
- Hemodialysis, Home · Phase 2/Phase 3
- Hemolysis · Early Phase 1
- Hepatic Encephalopathy · Phase 1/Phase 2
- Hepatitis C · Phase 1
- Hernia, Diaphragmatic · Phase 4
- Hernias, Diaphragmatic, Congenital · Phase 2
- Hypertension · Phase 4
- Hypertension, Pulmonary · Phase 4
- Hypogonadism · Early Phase 1
- Hypoplastic Left Heart Syndrome · Phase 2
- Hypoxia-Ischemia, Brain · Phase 2
- Idiopathic Pulmonary Fibrosis · Phase 4
- Immersion · Phase 2
- Infant, Premature · Phase 2
- Infertility · Phase 4
- Infertility, Female · Phase 4
- Insulin Resistance · Phase 1/Phase 2
- Ischemia · Phase 2
- Ischemic Stroke · Phase 1
- Kidney Diseases · Phase 2
- Labor, Obstetric · Phase 1
- Live Birth · Phase 1
- Liver Cirrhosis · Phase 4
- Lung · Phase 1/Phase 2
- Lung Diseases · Phase 4
- Lung Diseases, Interstitial · Phase 4
- Lupus Erythematosus, Systemic · Early Phase 1
- Lymphangioma · Phase 1/Phase 2
- Lymphatic Diseases · Phase 2
- Macular Degeneration · Phase 2
- Meconium Aspiration Syndrome · Phase 4
- Meniere Disease · Phase 2
- Metabolic Syndrome · Phase 4
- Migraine with Aura · Early Phase 1
- Mitral Valve · Phase 2/Phase 3
- Muscular Diseases · Phase 4
- Muscular Dystrophy, Duchenne · Phase 2
- Myelodysplastic Syndromes · Phase 1/Phase 2
- Neonatology · Phase 2
- Neoplasms · Phase 2/Phase 3
- Neuralgia, Postherpetic · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 2
- Obesity · Phase 4
- Oligohydramnios · Phase 2
- Ovulation · Phase 2
- Palmar Plate · Phase 1
- Pancreatic Neoplasms · Phase 1
- Parkinson Disease · Phase 4
- Penile Induration · Phase 4
- Peripheral Arterial Disease · Phase 3
- Persistent Fetal Circulation Syndrome · Phase 4
- Pharmacokinetics · Phase 1/Phase 2
- Post-Concussion Syndrome · Phase 2
- Pre-Eclampsia · Phase 2/Phase 3
- Premature Ejaculation · Phase 4
- Priapism · Phase 2
- Prostatic Hyperplasia · Phase 2
- Prostatic Neoplasms · Phase 4
- Prostatitis · Phase 4
- Pulmonary Arterial Hypertension · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Pulmonary Edema · Phase 2
- Pulmonary Embolism · Phase 1
- Pulmonary Fibrosis · Phase 3
- Quality of Life · Phase 4
- Raynaud Disease · Phase 3
- Rectal Neoplasms · Phase 3
- Renal Dialysis · Phase 4
- Respiratory Insufficiency · Phase 2
- Retinitis Pigmentosa · Phase 2
- Risk Factors · Phase 1
- Safety · Phase 4
- Sarcoma · Phase 1
- Schizophrenia · Phase 4
- Scleroderma, Diffuse · Phase 3
- Scleroderma, Limited · Phase 3
- Scleroderma, Systemic · Phase 3
- Sclerosis · Early Phase 1
- Sexual Dysfunction, Physiological · Phase 4
- Sexual Dysfunctions, Psychological · Phase 2
- Sexual Health · Phase 2
- Smoking · Phase 1/Phase 2
- Spinal Cord Injuries · Phase 4
- Stroke · Phase 1
- Subarachnoid Hemorrhage · Phase 2
- Systole · Phase 3
- Testosterone · Phase 4
- Thalassemia · Phase 4
- Therapeutic Equivalency · Phase 1
- Thrombosis · Early Phase 1
- Traumatology · Early Phase 1
- Tricuspid Atresia · Phase 2
- Ulcer · Phase 2
- Ultrasonography · Early Phase 1
- Univentricular Heart · Phase 3
- Ureteral Diseases · Phase 4
- Urinary Bladder Neoplasms · Phase 2
- Urinary Bladder, Overactive · Phase 1
- Urinary Incontinence · Phase 2
- Urogenital Neoplasms · Phase 1
- Urolithiasis · Phase 4
- Vascular Diseases · Early Phase 1
- Vascular System Injuries · Phase 2
- Vasospasm, Intracranial · Phase 2
- Ventricular Dysfunction, Left · Phase 4
- Vitelliform Macular Dystrophy · Phase 2
- Volunteers · Phase 1
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
- Phosphodiesterase 5AINHIBITOR
PDE5A inhibitor
Approval history
- approvedPriority reviewMar 27, 1998
Chemistry & pharmacology
Loading structure…
SMILES
CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12- Mol. weight
- 474.59 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL192 ↗
- WikipediaSildenafil ↗
- NCATS3M7OB98Y7H ↗
- ChEMBLCHEMBL1737 ↗
Also known as
- 1-((3-(4,7-dihydro-1-methyl-7-oxo-3-propyl-1h-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methylpiperazine
- 1-((3-(4,7-dihydro-1-methyl-7-oxo-3-propyl-1h-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methylpiperazine
- nipatra
- revatio
- revatio
- revatio
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil
- sildenafil citrate
- sildenafil citrate
- sildenafil citrate
- sildenafil citrate
- sildenafil citrate
- sildenafil citrate
- sildenefil
- td0025
- uk-92480
- uk-92480
- uk-9248010
- uk-9248010
- uk-92480-10
- uk-92480-10
- viagra
- viagra
- viagra
- viagra
- vizarsin
- vizarsin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07290400 | Phase 2 | Apr 15, 2026 | Aspargo Labs, Inc |
| NCT07302698 | Phase 1 | Mar 15, 2026 | Aspargo Labs, Inc |
| NCT07039760 | Early Phase 1 (Phase 1) | Dec 1, 2025 | Washington University in St. Louis |
| NCT07177326 | Phase 3 | Oct 1, 2025 | Assiut University |
| NCT07117383 | Phase 1 | Aug 31, 2025 | Aspargo Labs, Inc |
| NCT06810284 | Phase 2 | Jul 31, 2025 | Assistance Publique - Hôpitaux de Paris |
| NCT06522854 | Phase 2 | May 1, 2025 | Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso, Lagos State University, Mater Medical Research Institute, National Health and Medical Research Council, Australia, University of Alabama, Birmingham, University of Lagos, University of Queensland |
| NCT06377098 | Phase 2 | May 1, 2025 | Cameroon Baptist Convention Health, University of Alabama, Birmingham, University Teaching Hospital, Lusaka, Zambia |
| NCT06800092 | Phase 2/Phase 3 (Phase 3) | Feb 15, 2025 | University of Texas, Galveston |
| NCT06289881 | Phase 1 | Feb 4, 2025 | Bio-innova Co., Ltd |
| NCT06954597 | Phase 2 | Feb 4, 2025 | Bioskin GmbH, Topadur Pharma AG |
| NCT06510322 | Early Phase 1 (Phase 1) | Jan 31, 2025 | Yeshiva University |
| NCT06649539 | Phase 4 | Oct 11, 2024 | Charitable Union for the Research and Education of Peyronie's Disease, Endo Pharmaceuticals |
| NCT07135037 | Phase 2 | Sep 1, 2024 | Kafrelsheikh University |
| NCT06123156 | Phase 3 | Jun 30, 2024 | Rouen Normandy University |
| NCT06778330 | N/A | Jun 1, 2024 | Fayoum University |
| NCT06324396 | Phase 1 | Mar 1, 2024 | Indiana University, University of Kansas |
| NCT06237751 | N/A | Feb 1, 2024 | First People's Hospital of Chenzhou |
| NCT06875258 | Phase 4 | Jan 15, 2024 | Netherlands Cancer Institute, Viatris |
| NCT06178523 | Phase 4 | Jan 1, 2024 | Batterjee Medical College |
Showing 20 of 409 trials
Page 1 / 21
Organizations
Research & Development (286)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 80 | 61 | 5 | 2001 |
| Ain Shams University | Academic/Hospital | 14 | 12 | 5 | 2011 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 13 | 2 | 5 | 2003 |
| National Institutes of Health (NIH) | Government | 12 | 1 | 4 | 2003 |
| Assiut University | Academic/Hospital | 11 | 11 | 5 | 2015 |
| Duke University | Academic/Hospital | 10 | 8 | 3 | 2007 |
| Vanderbilt University | Academic/Hospital | 9 | 7 | 5 | 2001 |
| The University of Texas, Dallas | Academic/Hospital | 7 | 1 | 4 | 2009 |
| University of Colorado, Denver | Academic/Hospital | 7 | 6 | 3 | 2007 |
| University of Copenhagen | Academic/Hospital | 7 | 7 | 5 | 2003 |
| University of Texas, Galveston | Academic/Hospital | 7 | 7 | 4 | 2010 |
| Cornell University | Academic/Hospital | 6 | 3 | 3 | 2004 |
| Eli Lilly | For profit | 6 | 6 | 2 | 2002 |
| Harvard University | Academic/Hospital | 6 | 4 | 3 | 2001 |
| Strategic Science & Technologies, LLC | For profit | 6 | 5 | 2 | 2013 |
| Bayer | For profit | 5 | 4 | 3 | 2005 |
| Beni Suef University | Academic/Hospital | 5 | 5 | 3 | 2017 |
| Johns Hopkins University | Academic/Hospital | 5 | 4 | 3 | 2006 |
| Technion University | Academic/Hospital | 5 | 5 | 2 | 2005 |
| University of Iowa | Academic/Hospital | 5 | 4 | 2 | 2007 |
286 organizations
Page 1 / 15
Marketing (62)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Nov 25, 2020 |
| Actavis | For profit | MKTG | Feb 25, 2013 |
| Actavis | For profit | SYN | Feb 25, 2013 |
| Ajanta Pharma Ltd | For profit | MKTG | May 4, 2018 |
| Alkem Labs Ltd | For profit | MKTG | Jul 12, 2019 |
| Amneal Pharmaceuticals | For profit | MKTG | Feb 28, 2013 |
| Amneal Pharmaceuticals | For profit | SYN | Jun 27, 2018 |
| Apotex | For profit | MKTG | Apr 25, 2011 |
| Appco Pharma | For profit | SYN | Aug 7, 2017 |
| Appco Pharma | For profit | MKTG | Aug 7, 2017 |
| Aptapharma Inc | For profit | MKTG | Aug 6, 2020 |
| Aurobindo Pharma | For profit | MKTG | Apr 1, 2015 |
| CMP Therapeutics Ltd | For profit | MKTG | Apr 28, 2023 |
| CMP Therapeutics Ltd | For profit | NDA2 | Apr 28, 2023 |
| Cadila Healthcare | For profit | MKTG | Nov 28, 2023 |
| Changchun Changsheng Life Science and Technology Co., Ltd. | For profit | MKTG | Nov 6, 2012 |
| Chartwell Pharmaceuticals | For profit | MKTG | Nov 6, 2012 |
| Dr. Reddy's Laboratories | For profit | MKTG | Sep 26, 2012 |
| Eugia Pharma | For profit | MKTG | Apr 1, 2015 |
| Granules India | For profit | MKTG | Dec 1, 2023 |
| Hetero Labs Ltd | For profit | MKTG | Nov 26, 2014 |
| IBSA Institut Biochimique SA | For profit | MKTG | Dec 16, 2025 |
| Invagen Pharms | For profit | MKTG | Aug 6, 2020 |
| Jubilant Innovation Ltd. | For profit | MKTG | Dec 20, 2024 |
| Lupin | For profit | MKTG | Mar 22, 2019 |
| Lupin | For profit | SYN | Mar 23, 2022 |
| MSN Laboratories | For profit | MKTG | Feb 8, 2022 |
| Macleods Pharmaceuticals, Ltd | For profit | SYN | Dec 17, 2013 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Dec 17, 2013 |
| Meda Pharmaceuticals | For profit | NDA2 | Nov 18, 2009 |
| Mylan | For profit | SYN | Mar 25, 2019 |
| Mylan | For profit | MKTG | Nov 9, 2012 |
| Neogen | For profit | MKTG | Dec 17, 2013 |
| Novitium Pharma | For profit | MKTG | May 31, 2019 |
| Perrigo | For profit | MKTG | Apr 23, 2020 |
| Pfizer | For profit | SYN | Mar 27, 1998 |
| Pfizer | For profit | NDA | Jun 3, 2005 |
| Reyoung Pharma Co Ltd | For profit | SYN | Apr 21, 2017 |
| Reyoung Pharma Co Ltd | For profit | MKTG | Jun 12, 2020 |
| Rubicon Research | For profit | MKTG | Jun 20, 2016 |
| Rubicon Research | For profit | SYN | Jun 20, 2016 |
| Sun Pharmaceuticals | For profit | MKTG | Nov 16, 2021 |
| Sunshine Lake Pharma Co., Ltd. | For profit | MKTG | Jun 11, 2020 |
| Sunshine Lake Pharma Co., Ltd. | For profit | SYN | Jun 11, 2020 |
| Taro Pharmaceuticals | For profit | MKTG | Nov 16, 2021 |
| Taro Pharmaceuticals | For profit | SYN | Nov 16, 2021 |
| Teva | For profit | SYN | Aug 1, 2019 |
| Teva | For profit | SYN | Mar 9, 2016 |
| Teva | For profit | MKTG | Jan 7, 2013 |
| Torrent Pharmaceuticals Limited | For profit | SYN | Jun 11, 2018 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Nov 6, 2012 |
| Tris Pharma, Inc. | For profit | MKTG | Nov 17, 2021 |
| Umedica Labs Pvt Ltd | For profit | MKTG | Aug 25, 2020 |
| Umedica Labs Pvt Ltd | For profit | SYN | Aug 25, 2020 |
| Upjohn | For profit | MKTG | Mar 27, 1998 |
| Viatris | For profit | MKTG | Mar 27, 1998 |
| Viatris | For profit | NDA2 | Mar 27, 1998 |
| Watson Pharmaceuticals | For profit | SYN | Nov 5, 2012 |
| Watson Pharmaceuticals | For profit | MKTG | Nov 6, 2012 |
| Yiling Pharmaceutical Inc. | For profit | MKTG | Nov 6, 2012 |
| Zydus Discovery DMCC | For profit | MKTG | Sep 29, 2022 |
| Zydus Discovery DMCC | For profit | SYN | Sep 29, 2022 |