ExcelMale.com
    • Two New Testosterone Formulations Flunk FDA Panel

      It's a bad day for Big Pharma when it comes to new testosterone formulations. Two new drugs, Tlando and Jatenzo did not gain approval by an FDA advisory panel. Both are oral forms of testosterone undecanoate, meant to be taken daily. The two new drugs were turned down over fears of side effects on cardiovascular health and cholesterol levels. The financial press has the news:

      Lipocine arrived at the FDA meeting armed with data from two phase 3 trials showing Tlando moves average serum testosterone concentrations up into the normal range in most people. That result was enough for the studies to meet their primary endpoints. But the overall dataset failed to quell fears about cardiovascular adverse events and the drug’s effect on blood pressure.

      This article was originally published in forum thread: Two New Testosterone Formulations Flunk FDA Panel
      Comments 4 Comments
      1. Will Brink's Avatar
        Will Brink -
        Oral testosterone undecanoate has been around forever, and those who tried it back in the day (Andriol) at very high doses, found it useless. Not sure what tweaks, if any, they have made to these new oral testosterone undecanoate products, but it all but disappeared from the market for a reason, it kinda sucked
      1. CoastWatcher's Avatar
        CoastWatcher -
        Quote Originally Posted by Will Brink View Post
        Oral testosterone undecanoate has been around forever, and those who tried it back in the day (Andriol) at very high doses, found it useless. Not sure what tweaks, if any, they have made to these new oral testosterone undecanoate products, but it all but disappeared from the market for a reason, it kinda sucked
        It's still sold here in Canada...actually, I should write it's available for sale. Pharmacists tell me they rarely see a prescription for it.
      1. Jinzang's Avatar
        Jinzang -
        I don't know what tweaks have been made, but I assume there have been some. Without patent protection the drug companies would not be interested in oral testosterone undecanoate. The news reports say that the clinical trials showed the drugs increased blood levels of testosterone into the normal range. Perhaps the normal range is not good enough for body builders.
      1. Will Brink's Avatar
        Will Brink -
        Quote Originally Posted by Jinzang View Post
        I don't know what tweaks have been made, but I assume there have been some. Without patent protection the drug companies would not be interested in oral testosterone undecanoate. The news reports say that the clinical trials showed the drugs increased blood levels of testosterone into the normal range. Perhaps the normal range is not good enough for body builders.
        It was not apparently good enough for anyone as few if any docs used it for TRT. Bbing doses were commonly well above what's used for TRT and interest dropped rapidly. To me, it's a classic example of something that "looks good on paper" but does not translate well into real world/clinical use. Whether these new forms are an improvement, I don't know. Might never know considering the lack of approval.
    • You have probably reached our site in your search for health and potency. Are you wondering who to trust with men’s health information in an online world full of scammers and deception? Well, you are in the right place!

      Welcome to ExcelMale.com, one of the largest and best moderated men’s health forums on the Internet focused on increasing health, potency and productivity in men. With over 13,000 members (as of April 2016) that include educated men, physicians, pharmacists, dietitians, exercise trainers, nutritional supplement experts, and other professionals in the field, ExcelMale is fast becoming a leader in the field. Our forum topics range from testosterone replacement therapy, Trimix injections use for ED, HCG use for better fertility and libido, estradiol management, thyroid function optimization, peptide information, exercise routines, best supplements for men, high protein diets, testosterone side effect management and much more. We also provide men’s health information via Interviews with experts, Videos, and webinars. Last but not least, our members share their reviews of hormone replacement clinics and doctors, compounding pharmacies, pharmaceutical products, supplements, and much more. Our great moderators review every post daily to detect spammers or abuse, so ExcelMale is a safe environment for all men. And since every man wants to help important women in their lives, we do not neglect female health information as we include a folder called “ExcelFemale” to post the latest on HRT in women.


      Search our content by typing your question here.

      Register here to join our community! Don’t be shy, ask questions by posting in any forum folder. We can help each other to regain our best selves!.


      Wishing you the greatest health,

      Nelson Vergel

      Founder