Tesamorelin — Stabilised GHRH Analogue

Background

Tesamorelin (Egrifta®) is a synthetic stabilised analogue of human growth hormone-releasing hormone (GHRH 1-44) with an N-terminal trans-3-hexenoyl moiety conferring resistance to dipeptidyl peptidase IV. It was developed by Theratechnologies and approved by the FDA in 2010.

Mechanism

Tesamorelin binds the GHRH receptor on pituitary somatotrophs, stimulating endogenous, pulsatile growth hormone secretion. This preserves the physiological GH feedback architecture (unlike exogenous recombinant hGH).

What is proven

Phase 3 trials in HIV-infected patients with excess abdominal fat (lipodystrophy) demonstrated approximately 15–20% reduction in visceral adipose tissue measured by CT scan over 26 weeks, with improvements in triglycerides and patient-reported body image. These are the trials supporting the FDA-approved Egrifta® indication.

Pilot work has explored tesamorelin in MASH/NAFLD, mild cognitive impairment (PET-imaged amyloid changes have been reported), and HIV-associated neurocognitive disorder, with promising but preliminary results.

What is NOT proven

Use for general body recomposition, athletic recovery, or anti-ageing in non-HIV populations is not supported by registrational trials. Long-term oncological surveillance specific to non-HIV populations is limited.

Open research questions

Definitive efficacy in MASH/NAFLD; cognitive endpoints in HIV-associated neurocognitive disorder and Alzheimer's risk populations; long-term IGF-1 elevation and any associated risk in non-HIV populations.

Regulatory status

FDA-approved (2010) as Egrifta® for HIV-associated lipodystrophy. Approved in Canada and a small number of other jurisdictions for the same indication. Not approved for general weight management, anti-ageing, or athletic use.

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