Tesamorelin 2 mg or 1.4 mg

[Researcher6076]

So I'm confused. The clinical trials for Tesamorelin used a 2 mg dosage daily. And that's the dose I most commonly see discussed in the forums. But the actual FDA approved product calls for a SC dose of 1.4 mg.

I'm confused about what dose is correct.

I do know with other GH secretagogues more isn't always better.

Can anyone explain how the FDA ended up approving a lower dose than what was used in the clinical trials?

Can anyone provide guidance in what dose is more appropriate?

 

[RadicalCrimson]

I think 3 different formulations were approved at different times: the original, WR, and SV.
I don't know how the newer formulations differ, but I know that the 2mg dose was chosen for the phase 3 trial because the phase 2 trial that compared it with 1mg showed that the VAT reduction with 1mg was not statistically different 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