Is Tesamorelin (compounded) legal in the US?
Yes, FDA approved for belly fat in adults with HIV; other uses are not approved.
Tesamorelin is FDA-approved as Egrifta (Egrifta SV, and since March 2025 Egrifta WR) only for reducing excess abdominal fat in adults with HIV who have lipodystrophy. Compounded tesamorelin sold for fat loss, muscle or anti-ageing in people without HIV is not an FDA-approved product and that use has no approved indication. 531
The molecule is approved as Egrifta, but only for HIV-associated lipodystrophy. A compounded preparation is not an FDA-approved product. Prescribing it for belly fat in someone without HIV is off-label use of an unreviewed preparation. 51
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More on Tesamorelin (compounded)
Citations
- DailyMed: Egrifta SV (tesamorelin) prescribing information dailymed.nlm.nih.gov
- Falutz 2010, J Acquir Immune Defic Syndr: tesamorelin in HIV abdominal fat accumulation, RCT with extension pubmed.ncbi.nlm.nih.gov
- DailyMed: Egrifta WR (tesamorelin) prescribing information dailymed.nlm.nih.gov
- Falutz 2008, AIDS: long-term safety and effects of tesamorelin, extension study doi.org
- FDA label, 2025: Egrifta WR accessdata.fda.gov
- Makimura 2012, J Clin Endocrinol Metab: tesamorelin in obese subjects with reduced GH secretion, RCT pubmed.ncbi.nlm.nih.gov
- Stanley 2019, Lancet HIV: tesamorelin for NAFLD in HIV, RCT pubmed.ncbi.nlm.nih.gov
- Falutz 2007, NEJM: metabolic effects of a GHRH analog in patients with HIV pubmed.ncbi.nlm.nih.gov
- Falutz 2010, J Clin Endocrinol Metab: pooled analysis of two phase 3 tesamorelin trials pubmed.ncbi.nlm.nih.gov
- Clemmons 2017, PLoS One: tesamorelin in type 2 diabetes, RCT pubmed.ncbi.nlm.nih.gov
- 2007, Basic Clin Pharmacol Toxicol: non-clinical pharmacology of TH9507 pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Tesamorelin (compounded) article, fact-checked against the cited sources. No dosing anywhere on this site.