Family · gh
Tesamorelin
Egrifta; Egrifta SV/WR; TH9507; tesamorelin acetate
Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH 1-44, stabilized at the N-terminus). It binds GHRH receptors on pituitary somatotrophs, stimulating pulsatile, physiologic-pattern release of endogenous growth hormone, which in turn raises IGF-1 and shifts fat metabolism toward reduction of visceral adipose tissue.
Tesamorelin is one of the few peptides in this class with genuine Phase III randomized, placebo-controlled trial support and a real regulatory approval — but for a narrow indication. Pooled analyses of two multicenter double-blind trials (n≈800-806) in HIV-infected adults with lipodystrophy showed roughly 15-18% reduction in visceral adipose tissue versus placebo at 26 weeks, with a 52-week extension confirming durability of effect and improvements in trunk fat, waist circumference and IGF-1. A separate randomized trial also reported reductions in liver fat. Long-term cardiovascular outcomes and safety beyond about a year have not been established, and effects reverse after discontinuation.
- Reduction of excess visceral abdominal fat in HIV-associated lipodystrophy (the approved use)
- Research interest in GH/IGF-1 axis stimulation and visceral fat physiology outside this indication
Educational overview only — no dosing instructions in the public hub.
Reported adverse effects in trials include injection-site reactions, arthralgia, myalgia, peripheral edema, and increases in IGF-1; because it raises endogenous GH/IGF-1, it carries a class warning against use in patients with active or suspected malignancy, and glucose tolerance should be monitored (risk of hyperglycemia). It is contraindicated in pregnancy and in disruption of the hypothalamic-pituitary axis. Long-term cardiovascular and cancer-risk data are limited.
Any material offered outside licensed pharmacy channels should be treated as Research Use Only. Independent third-party CoA (identity + purity by HPLC, quantification, and mass-spec confirmation) is the minimum bar; verify the lab and lot number match the vial in hand before assuming any purity claim.
US: FDA-approved prescription drug (Egrifta/Egrifta SV/Egrifta WR) specifically for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy — not approved for any other use. EU/UK: not approved; the manufacturer withdrew its EMA marketing-authorization application in 2012 after the CHMP concluded the benefit-risk balance was not established, so it has no legal medicinal status in the EU/UK and circulates there only as an unapproved/RUO substance. Use outside the approved indication and outside licensed medical supervision is not supported by regulators anywhere.
Frequently asked questions
- What is Tesamorelin used for?
- Reduction of excess visceral abdominal fat in HIV-associated lipodystrophy (the approved use). Research interest in GH/IGF-1 axis stimulation and visceral fat physiology outside this indication. Tesamorelin is one of the few peptides in this class with genuine Phase III randomized, placebo-controlled trial support and a real regulatory approval — but for a narrow indication. Pooled analyses of two multicenter double-blind trials (n≈800-806) in HIV-infected adults with lipodystrophy showed roughly 15-18% reduction in visceral adipose tissue versus placebo at 26 weeks, with a 52-week extension confirming durability of effect and improvements in trunk fat, waist circumference and IGF-1. A separate randomized trial also reported reductions in liver fat. Long-term cardiovascular outcomes and safety beyond about a year have not been established, and effects reverse after discontinuation.
- Is Tesamorelin legal in Europe?
- US: FDA-approved prescription drug (Egrifta/Egrifta SV/Egrifta WR) specifically for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy — not approved for any other use. EU/UK: not approved; the manufacturer withdrew its EMA marketing-authorization application in 2012 after the CHMP concluded the benefit-risk balance was not established, so it has no legal medicinal status in the EU/UK and circulates there only as an unapproved/RUO substance. Use outside the approved indication and outside licensed medical supervision is not supported by regulators anywhere.
- What are the risks and side effects of Tesamorelin?
- Reported adverse effects in trials include injection-site reactions, arthralgia, myalgia, peripheral edema, and increases in IGF-1; because it raises endogenous GH/IGF-1, it carries a class warning against use in patients with active or suspected malignancy, and glucose tolerance should be monitored (risk of hyperglycemia). It is contraindicated in pregnancy and in disruption of the hypothalamic-pituitary axis. Long-term cardiovascular and cancer-risk data are limited.
- How is the quality of Tesamorelin assessed?
- Any material offered outside licensed pharmacy channels should be treated as Research Use Only. Independent third-party CoA (identity + purity by HPLC, quantification, and mass-spec confirmation) is the minimum bar; verify the lab and lot number match the vial in hand before assuming any purity claim.