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LEVITRA (vardenafil)
Vardenafil inhibits phosphodiesterase type 5 (PDE5) in the corpus cavernosum, increasing cyclic GMP levels and promoting smooth muscle relaxation and vasodilation to enable erectile function.
Vardenafil inhibits phosphodiesterase type 5 (PDE5) in the corpus cavernosum, increasing cyclic GMP levels and promoting smooth muscle relaxation and vasodilation to enable penile erection. Used for Erectile dysfunction in adult men.
At a glance
| Generic name | LEVITRA (vardenafil) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Phosphodiesterase type 5 (PDE5) inhibitor |
| Target | PDE5 (phosphodiesterase type 5) |
| Modality | Small molecule |
| Therapeutic area | Urology / Sexual Health |
| Phase | FDA-approved |
Mechanism of action
Vardenafil is a selective PDE5 inhibitor that blocks the degradation of cyclic guanosine monophosphate (cGMP) in penile tissue. By preventing cGMP breakdown, the drug allows sustained smooth muscle relaxation and increased blood flow to the corpus cavernosum during sexual stimulation. This mechanism restores the natural erectile response in men with erectile dysfunction.
Approved indications
- Erectile dysfunction in adult males
Common side effects
- Headache
- Flushing
- Dyspepsia
- Nasal congestion
- Back pain
- Dizziness
Key clinical trials
- A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234 (PHASE1)
- Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn (PHASE1, PHASE2)
- Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (PHASE3)
- A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension (PHASE2)
- Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism (PHASE4)
- Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients? (PHASE2)
- PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) (PHASE4)
- Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LEVITRA (vardenafil) CI brief — competitive landscape report
- LEVITRA (vardenafil) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI