VIAGRA (sildenafil citrate)
Viagra treats erectile dysfunction by helping patients achieve an erection in response to sexual stimulation. It is used to improve the physical response during sexual activity by facilitating the necessary blood flow to the penis. This medication is typically prescribed for those experiencing difficulty with the natural physiological processes required for an erection.
How VIAGRA Works
This medication works by inhibiting the PDE5 enzyme, which is responsible for breaking down a substance called cGMP in the penis. By preventing this breakdown, the drug enhances the effects of nitric oxide released during sexual stimulation, leading to smooth muscle relaxation and increased blood flow.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-03-27
- Routes
- ORAL
- Dosage Forms
- TABLET
VIAGRA Approval History
What VIAGRA Treats
1 indicationsVIAGRA is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erectile Dysfunction
VIAGRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VIAGRA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05061368 | Pro00108944 | Ph 2 | recruiting | Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD |
| NCT04565925 | 20-0197 | Ph 2 | recruiting | Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries |
| NCT06178523 | RES/2024/1 | Ph 4 | completed | Cost-effective Treatment of Unexplained Infertility |
| NCT06782659 | ASP-001-005-BE | Ph 1 | not yet recruiting | Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants. |
| NCT04898114 | Neb-Mag-2 | Ph 1, Ph 2 | recruiting | Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn |
| NCT01817751 results posted | MCC-14816 HM14816, NCI-2013-00705 | Ph 2 | completed | Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma |
| NCT04169191 SANE-02 | SANE-02 | Ph 1 | active not recruiting | Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia |
| NCT00871065 | 0165-08-FB | Ph 2 | withdrawn | Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm |
| NCT05846906 | REC-H-PhBSU-21015 | Ph 2, Ph 3 | completed | Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness |
| NCT03686813 results posted | Pro00100971 | Ph 2 | completed | Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention |
| NCT03417492 | 827103 | Ph 1 | terminated | Cerebrovascular Reactivity in American Football Players |
| NCT02060487 AFFILIATE results posted | A1481324 2013-004362-34, AFFILIATE | Ph 4 | terminated | Effects of Oral Sildenafil on Mortality in Adults With PAH |
| NCT01247805 | A1481293 EudraCT 2010-023521-38 | Ph 1 | completed | A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions |
| NCT01656798 | A1481313 | Ph 1 | completed | Food Effect Study For New Formulation |
| NCT01737203 | A1481315 | Ph 1 | completed | Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil |
| NCT00430716 results posted | A1481244 2006-006748-76 | Ph 4 | terminated | To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. |
| NCT03598140 results posted | STU 032018-063 | Ph 2 | terminated | Sildenafil Treatment for Mild TBI |
| NCT02466802 | MCC-13-09812 HM20004297, NCI-2015-01101 | Ph 1 | completed | Study of Regorafenib and Sildenafil for Advanced Solid Tumors |
| NCT03766594 | SURPL | Ph 1 | completed | Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss |
| NCT01950923 | IRB00021729-1 NCI-2013-00988, P30CA012197 | Ph 1 | completed | Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer |
| NCT02620995 | CAAE 17663813.4.0000.5272 | Ph 4 | completed | Effects of Sildenafil on Penile Vascular Function in Hypertensive Men With Erectile Dysfunction |
| NCT03431649 | TAshirley | Ph 4 | completed | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children |
| NCT02590536 | SFGR | Ph 3 | completed | A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction |
| NCT02129725 results posted | 110206-substudy | Ph 4 | completed | Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle. |
| NCT02628847 | 53515 | Ph 1 | terminated | Sildenafil and Stroke Recovery |
| NCT01347008 results posted | FAPESP 2011/00012-3 | Ph 3 | completed | Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis |
| NCT01514903 | HM-SIL-102 | Ph 1 | completed | Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers |
| NCT00862043 SIOVAC | FIBHGM-SIOVAC 2007-007033-40, EC07-90772 | Ph 4 | completed | Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease |
| NCT02845388 | Ainshams2015Omar | Ph 2 | completed | Sildenafil Citrate in Frozen Embryo Transfer |
| NCT01830790 results posted | Pro00042897 | Ph 2 | terminated | Effects of Sildenafil on Choroidal Thickness in AMD |
| NCT01219023 JADE | Pro00021480 | Ph 1 | completed | Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil |
| NCT01122264 results posted | 13085 H6D-EW-LVIJ | Ph 4 | completed | A Study in Patients With Erectile Dysfunction |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIAGRA FDA Label Details
Indications & Usage
FDA Label (PDF)VIAGRA is indicated for the treatment of Erectile Dysfunction.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment