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.
In 2009, we completed a Phase 2b Androxal clinical trial in men of reproductive age with low testosterone levels who wanted to improve or maintain their fertility and/or sperm function while being treated for low testosterone.
We submitted a new IND to the Division of Metabolic and Endocrine Products, or DMEP, for the investigation of Androxal® as a potential treatment for type 2 diabetes. On February 1, 2010, we received confirmation from the DMEP that our new IND was accepted and, as a result, we may initiate a Phase 2 trial.