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GEN News Highlights : Sep 25, 2012

Phase III Success for Oral Testosterone Replacement Therapy

Clarus Therapeutics reported positive topline data from a Phase III trial evaluating its oral testosterone replacement therapy CLR-610 in men with low serum testosterone. Results from the positive-controlled trial showed that 87% of 141 men treated with the drug achieved serum testosterone levels in the normal range (300–1,000 ng/dL) after 90 days of treatment. The average testosterone level achieved was 624 ng/dL.

In comparison, 80% of 146 men treated with the transdermal T-gel testosterone replacement therapy achieved normal serum testosterone levels, which averaged at 480 ng/dL. To meet FDA efficacy guidelines for a testosterone replacement therapy 75% of treated men should achieve testosterone levels in the normal range after 90 days of therapy.

“We are particularly excited about the significant number of men receiving CLR-610 who achieved normal testosterone levels in this study,” comments Bela S Denes, M.D., Clarus CMO. “Market research shows that men currently being treated for low T with transdermal or injectable products would overwhelmingly prefer an oral option. Thus, we believe CLR-610 will have strong appeal.”

CLR-610 is Clarus Therapeutics' primary development candidate. The testosterone undecanoate prodrug has been formulated to facilitate absorption via the intestinal lymphatic pathway, and is taken orally twice a day as a softgel capsule.