Two New Testosterone Formulations Flunk FDA Panel

[Jinzang]

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.

 

[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

 

[CoastWatcher]

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.

 

[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.

 

[Will Brink]

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.