For research and educational purposes only. Not medical advice.

Tesamorelin Reference

Educational, not medical advice reference for Tesamorelin: Fat Loss, GH Release; regulatory status, evidence posture, source review, and schedul…

Reference summary

Pivotal evidence comes from two identically designed Phase 3 trials in HIV-infected adults with abdominal fat accumulation (Falutz 2007 NEJM and follow-up reports), which demonstrated reductions in visceral adipose tissue versus placebo with daily 2 mg subcutaneous dosing (the Egrifta SV reference dose; Egrifta WR is a reformulation at 1.28 mg). Off-label extrapolation to visceral-fat reduction in adults without HIV-associated lipodystrophy is not supported by adequately powered trials. This entry displays Egrifta WR label-reference fields plus the pivotal HIV-lipodystrophy program context; it does not approve research-vial tesamorelin protocols.

Regulatory and posture

Categories
Fat Loss, GH Release
Aliases
Egrifta WR, Egrifta SV, Growth hormone-releasing factor analog, GHRH(1-44) analog, TH9507
Evidence posture
human
Regulatory status
FDA-approved label reference exists for Egrifta WR to reduce excess abdominal fat in HIV-infected adults with lipodystrophy; it is not indicated for general weight-loss management or for non-HIV visceral-fat reduction. WADA prohibits tesamorelin at all times under category S2 (peptide hormones, growth factors, and related substances) because it is a GHRH analog that increases endogenous GH release.
Content review status
label verified

Selected public sources

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