Androxal® is an orally active small molecule under development that restores normal pituitary response in men resulting in normalization of testosterone and luteinizing hormone ("LH") levels.
We have initiated a Phase 2b Androxal clinical trial in men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone.
We also hope to submit a new IND, in the second half of 2009, to the Division of Metabolic and Endocrine Products ("DMEP"), of the FDA, to study the effects of Androxal in men with type two diabetes and low testosterone.