TesoRx Announces Successful Completion of Confirmative Study of Oral Testosterone Candidate TSX-049

  • Study Supports Moving TSX-049 Into Phase 1/2 Human Clinical Trials

(San Francisco, Calif.) September 22, 2020 - TesoRx LLC today announced the successful completion of a confirmative study in canines that was designed to predict the pharmacokinetic profile of TSX-049 for the oral treatment of hypogonadism. The results of the study confirmed that the newly optimized TSX-049 formulation candidate has enhanced bioavailability and a dose response sufficient to overcome negative feedback of gonadal testosterone production. TesoRx will be advancing TSX-049 into Phase 1/2 human clinical trials and anticipates a potential U.S. Food and Drug Administration approval as soon as 2023.

“Often times people taking testosterone products become frustrated with lifestyle restrictions like needing to cover their skin or not have physical contact to reduce the risk of testosterone transference to loved ones,” said Michael Oefelein, M.D., Chief Medical Officer of TesoRx. “The advancement of TSX-049 to human clinical trials means we may be able to offer an oral, once-daily product with more convenience and safety for patients in the future.”

TSX-049 is a novel, oral formulation of Testosterone containing Testosterone Undecanoate that is designed to help restore normal Testosterone levels in males with hypogonadism. By leveraging TesoRx’s proprietary proliposomal delivery platform to deliver modified Testosterone, TSX-049 has the potential to offer greater safety and convenience compared to existing topical and injectable treatments.

About TesoRX Pharma LLC

TesoRx Pharma LLC is focused on rapidly developing and commercializing pharmaceutical products in rare and specialty markets with limited treatment options and high unmet needs. Its growing pipeline includes assets in urology, oncology and rare diseases that have been formulated with TesoRx’s proprietary proliposomal delivery technology. The company was founded in 2010 through a collaboration with Western University of Health Sciences that includes joint R&D efforts at the TesoRx Centre of Excellence in Pomona, California. For more information, visit tesorx.com. 

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