Repros Therapeutics files at FDA enclomiphene citrate for hypogonadism in overweight men.

Repros Therapeutics Inc.announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal, has been accepted by the FDA, indicating that the application is sufficiently complete to permit a substantive review. This investigational product, which is the Company's lead product candidate, is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound. The Company is developing this product candidate for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. The Company's product candidate is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism.