Testosterone deficiency in men [defined as serum testosterone levels less than 300 ng/dL and accompanied by symptoms (e.g., reduced sex drive, lethargy, concentration difficulties, mild depression, muscle weakness, increased accumulation of abdominal fat)] is substantially more common than once appreciated and spans an age range from the early teens to men in their 50s and 60s and beyond.

Across all causes, the prevalence of testosterone deficiency in the U. S. is in excess of several million men. About 500,000 to 1 million men have testes that are incapable of producing testosterone.  However, most men with low levels of testosterone suffer from what is termed secondary hypogonadism – a condition that results when the pituitary gland in the brain fails to signal the testes to produce adequate levels of testosterone. 

Causes of testosterone deficiency are many and not all reasons are clearly understood.  However, in addition to genetically-linked causes (e.g., men with Klinefelter’s or Kallman Syndromes), testosterone deficiency is a relatively common occurrence in: a) older men (so-called geriatric hypogonadism); b) men infected with HIV; c) men suffering from type-II diabetes; d) men with significant cardiovascular disease; e) men with metabolic syndrome; and f) men with chronic illnesses such as kidney disease.

Also noteworthy is the link between low testosterone and erectile dysfunction in men. Testosterone is necessary for normal erectile function and as many as 20% of men who fail to respond to currently available erectile dysfunction products also have need for testosterone replacement therapy to achieve normal erectile function.

Several FDA-approved treatment options are available by prescription for testosterone deficiency, namely, topical testosterone gels, testosterone patches, testosterone injections, a buccal testosterone system and oral methyltestosterone. Of these, oral methyltestosterone is rarely prescribed due to concerns about liver toxicity. Thus, there is a clear opportunity in the market for an orally effective testosterone product that safely restores serum testosterone to within the normal range. Market research conducted for Clarus among current testosterone users and their prescribing physicians indicates an overwhelming preference for a safe and effective oral testosterone therapy compared to currently available products.

Clarus has developed a unique proprietary method for the oral delivery of testosterone. Appropriate U. S. and foreign patent applications have been filed and additional filings are anticipated as clinical development of OriTex™ proceeds.

OriTex™ is currently being evaluated in a Phase II clinical trial in hypogonadal men.