Tesamorelin 2 mg or 1.4 mg

[Researcher6076]

I'm trying to sort this out. In Tesamorelin's clinical trials, the daily amount given was 2 mg, and that's the figure that seems to come up most often in forum discussions. Yet the product that actually received FDA approval is dosed at 1.4 mg subcutaneously.

Which dose is the right one? That's what I can't figure out.

From what I understand about other GH secretagogues, taking more doesn't necessarily produce better results.

Why did the FDA approve a lower amount than the one studied in the trials? Could someone walk me through that?

And can anyone advise on which dose makes more sense to use?

 

[RadicalCrimson]

As far as I know, there were 3 separate formulations that got approval at various points: the initial one, WR, and SV.

I'm not sure what sets the newer formulations apart, but I do know the reason the 2mg dose was picked for the phase 3 trial: in the phase 2 trial comparing it against 1mg, the VAT reduction seen with 1mg could not be statistically distinguished from placebo.


https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000CrossR.pdf


The phase 2 trial: https://www.natap.org/2007/HIV/020807_05.htm