Tesamorelin

Tesamorelin is a stabilised synthetic analogue of human growth hormone-releasing hormone (GHRH) — the full 44-amino-acid GHRH sequence with a trans-3-hexenoic acid group on the N-terminus that resists dipeptidyl peptidase-IV (DPP-IV) degradation and extends its half-life. It binds GHRH receptors on anterior-pituitary somatotrophs, stimulating endogenous, pulsatile growth hormone secretion, which in turn raises hepatic insulin-like growth factor-1 (IGF-1).

Human evidence

FDA-approved for a specific indication (HIV-associated lipodystrophy); supported by randomized controlled human trials

Regulatory status

FDA-approved as Egrifta (2010), the reformulated Egrifta SV (2019), and Egrifta WR (tesamorelin F8, approved March 2025), for reduction of excess abdominal visceral fat in HIV-infected patients with lipodystrophy; it is a prescription medicine in the US and the only FDA-approved GHRH analogue. Note: the April 16, 2026 FDA Pharmacy Compounding Advisory Committee announcement and July 23-24, 2026 meeting concerned a different set of peptides (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon, emideltide/DSIP) for the Section 503A bulk-compounding list — tesamorelin was not part of that review, as it is already an approved drug.

• —Studied within its approved use for reducing visceral adipose tissue (VAT) in HIV-associated lipodystrophy, where controlled trials reported roughly 15-18% VAT reduction versus placebo.
• —Investigated in research settings for non-alcoholic fatty liver disease (NAFLD)/hepatic fat reduction, reflecting observed reductions in liver fat and liver enzymes in HIV-associated NAFLD.
• —Examined as a research probe of the GHRH/GH/IGF-1 axis and pulsatile GH secretion, including cognitive and metabolic studies in aging populations.

• ⚠Per the FDA Egrifta SV prescribing information, it is contraindicated in patients with disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity to tesamorelin or its excipients, and in pregnancy (animal data showed hydrocephaly in rat offspring during organogenesis).
• ⚠It raises IGF-1 levels; the label recommends monitoring IGF-1, with a theoretical concern about stimulating growth of pre-existing or undiagnosed malignancy.
• ⚠Reported adverse effects in trials include injection-site reactions, arthralgia/myalgia, pain in extremity, peripheral edema, and potential glucose intolerance or worsened glycemic control, so glucose status is monitored.
• ⚠NIH LiverTox assigns tesamorelin a low likelihood of clinically apparent liver injury ('E', unlikely), with liver enzymes generally neutral or improved in trials.