VARDENAFIL HYDROCHLORIDE
Vardenafil hydrochloride is a medication used for men experiencing erectile dysfunction. It helps patients achieve an erection by enhancing the physiological response to sexual stimulation. This drug is prescribed to improve sexual function by regulating blood flow within the penile tissues.
How VARDENAFIL HYDROCHLORIDE Works
This drug works by selectively blocking the phosphodiesterase type 5 (PDE5) enzyme, which normally breaks down a messenger called cGMP in the penile tissue. By preventing this breakdown, the medication allows cGMP to accumulate, which relaxes smooth muscles and increases blood flow to produce an erection. Because the process starts with the natural release of nitric oxide, the drug only functions when sexual stimulation is present.
Details
- Status
- None (Tentative Approval)
- First Approved
- 2012-05-03
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, TABLET
Companies
VARDENAFIL HYDROCHLORIDE Approval History
What VARDENAFIL HYDROCHLORIDE Treats
1 indicationsVARDENAFIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erectile Dysfunction
VARDENAFIL HYDROCHLORIDE 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.
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3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
VARDENAFIL HYDROCHLORIDE FDA Label Details
Indications & Usage
VARDENAFIL HYDROCHLORIDE is indicated for the treatment of Erectile Dysfunction.
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Full clinical data, patents, trials, and competitive landscape for vardenafil hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.