Tesamorelin

Tesamorelin is a synthetic 44-amino acid peptide analog of human growth hormone-releasing hormone (GHRH), developed by Theratechnologies. It preserves the full native GHRH sequence with an added N-terminal trans-3-hexenoic acid modification that improves stability against enzymatic degradation, extending its functional half-life compared to shorter analogs like sermorelin.

Tesamorelin is the only GHRH analog currently carrying active FDA approval in the United States. It is approved under the brand name Egrifta (and the newer Egrifta WR formulation) for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy — a condition characterized by abnormal fat distribution associated with antiretroviral therapy. An updated F8 formulation received FDA approval in early 2025, simplifying the dosing regimen.

Tesamorelin's FDA approval is supported by robust Phase 3 clinical trial data. Pivotal trials enrolled over 800 HIV-infected patients with lipodystrophy and demonstrated significant reductions in visceral adipose tissue after 26 weeks of daily subcutaneous administration, with extension studies showing sustained effects at 52 weeks. Additional research has shown associated improvements in lipid profiles, including triglyceride and cholesterol ratios.

Off-label interest in tesamorelin has grown in areas including body composition in non-HIV populations, non-alcoholic fatty liver disease (NAFLD/MASH), and age-related growth hormone decline. However, controlled clinical trial evidence for these off-label uses is limited compared to the HIV-lipodystrophy data. Tesamorelin stimulates endogenous GH release through the pituitary, meaning it preserves the body's natural feedback mechanisms rather than supplying exogenous GH directly.