Drugs in preclinical to phase II clinical development for the treatment of erectile dysfunction.

INTRODUCTION: Erectile function is an important aspect in the quality of life of many men. For men with erectile dysfunction (ED), a spectrum of treatment options exists. Novel therapies for ED are currently being developed in order to delay surgical placement of a penile prosthesis - the final step in the management of treatment-refractory ED. Areas covered: This review examines innovative treatments such as alternative vasoactive agents, trophic factors and bio-compounds as well as gene and stem cell therapy. All therapies are currently in some phase of development for the management of ED. Using the MedLine and FDA Clinical Trials Registry, recent developments in treatment of ED were queried. Expert opinion: Recent studies have demonstrated the potential for multiple, novel therapies in the treatment of ED. Much of the work requires further experimentation in large-scale, blinded, placebo-controlled studies. This will require a concerted effort to bring these products to market.