VYBRIQUE (sildenafil citrate)
Vybrique is a medication used for patients with erectile dysfunction. It helps individuals achieve an erection by facilitating the physiological response to sexual stimulation. This drug is prescribed to improve blood flow to the penis, though it requires natural sexual arousal to be effective.
How VYBRIQUE Works
This drug works by inhibiting the enzyme phosphodiesterase type 5 (PDE5), which is responsible for breaking down a messenger called cGMP. By preventing this degradation, the medication increases cGMP levels, leading to smooth muscle relaxation and increased blood flow into the penis. This process enhances the natural effects of nitric oxide released during sexual stimulation.
Details
- Status
- Prescription
- First Approved
- 2025-12-16
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- FILM
VYBRIQUE Approval History
What VYBRIQUE Treats
1 indicationsVYBRIQUE is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erectile Dysfunction
VYBRIQUE 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 VYBRIQUE
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
29 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 |
| 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 |
| 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 |
| 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.
VYBRIQUE FDA Label Details
Indications & Usage
FDA Label (PDF)VYBRIQUE is indicated for the treatment of Erectile Dysfunction.
VYBRIQUE Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VYBRIQUE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 16 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.