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Udenafil, a long-acting PDE5 inhibitor for erectile dysfunction
Emad A Salem1, Muammer Kendirci, Wayne J G Hellstrom
1Tulane University Health Sciences Center, Department of Urology, Section of Andrology, New Orleans, LA 70112, USA.
Current Opinion in Investigational Drugs (London, England : 2000)
|July 28, 2006
Summary
Udenafil, a PDE5 inhibitor, significantly improved erectile function in men with erectile dysfunction (ED) after 12 weeks. The drug was generally well-tolerated, with ongoing US trials.
Area of Science:
- Pharmacology
- Urology
- Clinical Trials
Background:
- Udenafil is an oral phosphodiesterase type 5 (PDE5) inhibitor.
- Currently available in South Korea for erectile dysfunction (ED) treatment.
- PDE5 inhibitors are a key therapeutic class for ED management.
Purpose of the Study:
- To evaluate the efficacy and safety of Udenafil in men with ED.
- To present Phase II clinical trial data for Udenafil.
- To inform ongoing and future clinical development of Udenafil.
Main Methods:
- Phase II clinical trial involving men with mild-to-severe ED.
- Treatment duration of 12 weeks.
- Assessment of erectile function improvement.
Main Results:
- Significant improvement in erectile function observed after 12 weeks of Udenafil treatment.
- Udenafil reported as well-tolerated in the study population.
- Further investigation into safety aspects was requested by regulatory authorities.
Conclusions:
- Udenafil demonstrates efficacy in improving erectile function in men with ED.
- The drug appears to be well-tolerated, warranting further clinical evaluation.
- Ongoing and planned clinical trials (Phase IIa, Phase III) will further assess Udenafil's profile.
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