About Us
OVERVIEW
We are a privately held pharmaceutical company focused on the development and commercialization of Tuclar, our oral testosterone (T) replacement product that is in Phase III clinical testing. If approved by the Food and Drug Administration (FDA), Tuclar will be a first-in-class oral T-replacement therapy in the United States. Tuclar contains a T prodrug, namely, T undecanoate (TU) that is acted upon by natural substances in the body to release T.
Based on our Phase II clinical results to date, Tuclar has successfully restored circulating T to normal levels in the vast majority of men with low T tested. Moreover, Tuclar has not been associated with liver toxicity – a principal safety concern historically associated with other oral T therapies like methyltestosterone. .
Men suffering from low T commonly are diagnosed after seeking treatment for symptoms including erectile dysfunction, or ED, reduced sex drive, fatigue, mild depression or increased body fat. Low T affects approximately 39% of men over 45 years of age according to a study published in the International Journal of Clinical Practice in 2006, yet only 12% of men with low T receive T-replacement therapy according to a study published in the Archives of Internal Medicine in 2008.
We believe a large portion of men with low T remain untreated because of a lack of awareness of low T and dissatisfaction with currently available T-replacement therapies, which are discussed fully in the Testosterone Deficiency section of our web site.
We believe Tuclar, if approved, will offer men and prescribing physicians a safe, effective and convenient oral T-replacement treatment.