Tesamorelin

Tesamorelin is unusual in our peptide library because it is the only one besides semaglutide with a clear FDA approval, but unlike semaglutide it is approved for just one narrowly defined indication. It belongs to the GHRH-analogue class: synthetic peptides modelled on the natural growth-hormone-releasing hormone the hypothalamus sends to the pituitary. The trans-3-hexenoyl modification at the N-terminus protects it from rapid breakdown by the enzyme DPP-4, giving it a usable clinical half-life and a once-daily subcutaneous schedule.

The pivotal trial evidence comes from the HIV-associated lipodystrophy programme. Two phase-3 randomised controlled trials run by the original sponsor (Theratechnologies) showed that 2 mg daily subcutaneous tesamorelin, given for 26 weeks, produced a meaningful reduction in visceral adipose tissue (the fat depot around abdominal organs) versus placebo in adults with HIV on antiretroviral therapy who had developed lipodystrophy-pattern fat accumulation. Long-term extension studies described the AE profile over 52 weeks. These trials are summarised in the FDA approval letter and the current Egrifta label, both linked below.

The mechanism (covered in 'How it works' above) is to bind the GHRH receptor on the pituitary and trigger pulsatile endogenous growth-hormone release, which raises IGF-1 modestly via the liver. That is a deliberately different design from injecting recombinant growth hormone (rhGH) directly: tesamorelin works by amplifying the body's own pulse pattern rather than imposing a fixed exogenous dose. The clinical effect in the approved indication is visceral-fat reduction; the cosmetic-fat (subcutaneous) effect is much smaller.

Off-label use is where most online and clinic discussion sits. Tesamorelin is frequently mentioned in body-composition, anti-ageing, and 'longevity' contexts because of its growth-hormone-axis mechanism, and small clinics, especially in the US, will sometimes prescribe it off-label for those reasons. The trial evidence base for those uses is essentially absent: the published trials are in the HIV-lipodystrophy population, on the labelled dose and schedule, for the labelled endpoint. We cover the off-label conversation honestly without endorsing it.

The US regulatory route is Egrifta (the original formulation, approved 2010) and Egrifta SV (a more concentrated formulation with a smaller injection volume, approved 2015). Both are prescription-only and supplied through US pharmacies. The current FDA label was last updated in 2025 (Drugs@FDA). Patient-assistance programmes from Theratechnologies may reduce cost for eligible patients.

Outside the US, tesamorelin has no marketing authorisation. The EMA application was withdrawn by Theratechnologies in 2012, and no successful re-application has followed. In the EU, EEA and UK, lawful access runs only through the unlicensed-medicine / named-patient framework: a prescribing clinician requests an unlicensed import for a specific patient and takes responsibility for the prescription. General or online sale to the public is not lawful. See the country pages at /regulation/[country]/tesamorelin for the specific situation in each jurisdiction.

Cost is meaningful even in the approved indication. Egrifta SV list price in the US has historically run roughly $3,000-$4,000 per month cash, with insurance coverage and patient-assistance programmes shifting the actual out-of-pocket cost considerably. In the EU/UK, named-patient supply costs depend on the import route and the supplier. The Practical considerations section below has the per-region picture in more detail.

This page is educational. We do not advise on starting, stopping, dosing or sourcing tesamorelin, and we do not facilitate the sale of any peptide. Decisions about whether to consider tesamorelin, on label or off, belong with a prescribing clinician who knows your history. Use the Regulation and Practical sections below for the operational picture, and the sources for the primary FDA and EMA documents.