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Pill for low testosterone in men heads for phase 2 clinical trials

August 1, 2012 3:43 pm by | 0 Comments

Company name: Teso Rx Pharma.

Industry: Pharmaceuticals.

Location: Menlo Park, California.

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Solution/product: TesoRx Pharma is currently developing TSX-002, an oral testosterone replacement therapy for men with hypogonadism. Its delivery system is intended to provide a convenient, outpatient method of delivering normal physiological levels of testosterone without the side effects associated with abnormally high levels of testosterone and other delivery methods.

Money raised: $5.9 million of a $6.6 million offering, according to a U.S. Securities and Exchange Commission filing. The company raised an undisclosed series A in 2010.

How it will be used: TesoRx held its first pre-IND meeting with the U.S. Food and Drug Administration in March 2011 and recently completed phase 1 trials. It’s now headed for phase 2 trials, according to a company rep.

Investors: Undisclosed.

Management team: CEO/co-founder TR Thirucote was vice president of pharmaceutical sciences at Roxro Pharma, which developed a nasal spray for use in postoperative pain treatment and was acquired by Luitpold Pharmaceuticals in 2010. With co-founder/chief science officer Guru Betageri and co-founder Will Roberts, he runs TesoRx as a virtual company that licenses compounds from small and midsized pharmaceutical companies and commercializes them.

Market size: The estimated prevalence of hypogonadism varies by study, depending on age groups tested and what testosterone level is considered “normal.” TesoRx says about 9 million men in the U.S. are affected by low testosterone — which can cause sexual dysfunction, depression and increased body fat — although only 10 percent of them receive treatment.

Increasing off-label use of testosterone replacement drugs has caused some controversy in recent years and has likely contributed to the rising sales of testosterone replacement therapies, which hit $1.6 million in 2011, according to Bloomberg data.

Competitors: There are no FDA-approved oral therapies on the market, but other testosterone replacement therapies include Solvay Pharmaceuticals’ (Abbott) AndroGel, Eli Lilly’s transdermal Axiron, Auxillium Pharmaceuticals and GlaxoSmithKline’s Testim gel and BioSante’s Bio T-Gel.Repros Therapeutics also has clinical-stage oral drug Androxal.

Copyright 2013 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Deanna Pogorelc

By Deanna Pogorelc MedCity News

Deanna Pogorelc is a Cleveland-based reporter who writes obsessively about life science startups across the country, looking to technology transfer offices, startup incubators and investment funds to see what’s next in healthcare. She has a bachelor’s degree in journalism from Ball State University and previously covered business and education for a northeast Indiana newspaper.
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