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Peptide profile · Growth hormone-releasing hormone (GHRH) analogue

Tesamorelin

Also known as: Egrifta, Egrifta SV, Egrifta WR, TH9507

An FDA-approved GHRH analogue that reduces visceral abdominal fat in HIV-associated lipodystrophy. Widely discussed off-label for body composition and cognition, where evidence is much thinner.

Established evidenceFDA-approved for this use
Abstract peptide-chain illustration for the tesamorelin profile

Evidence level

Established

Two phase 3 randomised, placebo-controlled trials (about 800 participants) showed roughly 15–18% reduction in visceral adipose tissue over 26 weeks in HIV-associated lipodystrophy. Evidence for other populations and outcomes is small-scale or absent.

Regulatory status (US)

FDA-approved for this use

FDA-approved (2010) for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Any other use — general body composition, NAFLD, cognition — is off-label. Prohibited in sport by WADA (S2).

Mechanism (proposed)

Stimulates pituitary GHRH receptors, increasing pulsatile growth hormone and IGF-1. In HIV-associated lipodystrophy this reduces visceral adipose tissue; the effect reverses on discontinuation.

Studied for: Visceral fat in HIV lipodystrophy (phase 3, approved), Liver fat in HIV with NAFLD (phase 2), Cognition in older adults / MCI (small trials), General body composition (off-label; limited)

Full research analysis

Tesamorelin: Approved Use, Off-Label Interest, and Clinical Evidence

Tesamorelin is the one GHRH analogue that finished phase 3 and won FDA approval — for excess abdominal fat in HIV-associated lipodystrophy. We separate that established evidence from the off-label uses it is now marketed for: general visceral fat, liver fat, and cognition.

Read the analysis

What tesamorelin is

Tesamorelin is a stabilised analogue of growth hormone-releasing hormone, developed to increase the body's own GH secretion rather than replace it. It was approved by the FDA in 2010 under the brand Egrifta for one indication: excess abdominal fat in HIV-infected adults with lipodystrophy.

Where the evidence stands

The approval rests on two phase 3 randomised placebo-controlled trials in HIV-infected adults with abdominal fat accumulation[1][2]. Visceral fat fell by roughly 15–18% over 26 weeks; the reduction was maintained with continued treatment and reversed when treatment stopped. That is established evidence for that use.

Off-label interest — visceral fat in people without HIV, liver fat, and cognition in older adults — is supported by much smaller studies, and the full analysis walks through each. None approaches phase 3 quality.

Regulatory position

FDA-approved for its labelled use; off-label otherwise. The label lists glucose intolerance, fluid retention and injection-site reactions, requires IGF-1 monitoring, and contraindicates use with active malignancy[3]. Prohibited in sport.

Safety summary

Labelled adverse reactions include injection-site reactions, arthralgia, peripheral oedema, myalgia and paraesthesia; glucose intolerance can occur; IGF-1 should be monitored. Contraindicated with active malignancy, in pregnancy, and with pituitary disruption. Long-term safety of chronic IGF-1 elevation remains a labelled concern.

Frequently asked questions

What is tesamorelin approved for?
Reduction of excess abdominal (visceral) fat in HIV-infected adults with lipodystrophy. That is the only FDA-approved indication.
Does tesamorelin work for belly fat in people without HIV?
This has not been established in trials of comparable size. Its mechanism should apply, but off-label evidence is small-scale, and the label warns the fat returns when treatment stops.
Is tesamorelin the same as CJC-1295 or sermorelin?
They are all GHRH analogues, but tesamorelin is the only one with phase 3 trials and an FDA approval.

References

Numbered in order of first use. Study type is shown for every source; see our methodology for how we rank evidence.

  1. 1.

    Falutz J, Allas S, Blot K, et al.. Metabolic effects of a growth hormone-releasing factor in patients with HIV New England Journal of Medicine, 2007.

    Randomized controlled trialHIV-infected adults with abdominal fat accumulationn = 412

    Result: Visceral adipose tissue decreased ~15% with tesamorelin vs ~5% increase with placebo at 26 weeks.

    Limitations: Effect reversed after discontinuation; single indication population.

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  2. 2.

    Falutz J, Mamputu JC, Potvin D, et al.. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat — a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data Journal of Clinical Endocrinology & Metabolism, 2010.

    Randomized controlled trialHIV-infected adults with abdominal fat accumulationn = 806

    Result: VAT reduced ~15–18% at 26 weeks; maintained with continued treatment to 52 weeks; regained on switching to placebo.

    Limitations: Extension phase partially open-label; single indication.

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  3. 3.

    Tesamorelin (Egrifta) prescribing information (DailyMed search) U.S. National Library of Medicine, DailyMed.

    Regulatory source

    Result: Approved indication, contraindications, warnings and adverse reactions.

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Review status: Editorially reviewed against primary sources. This article was fact-checked against the primary sources listed in the references by our editorial team, and it has not been reviewed by a licensed clinician. It is educational content, not medical advice. Read our editorial policy and methodology. Spotted an error? Tell us.

Profile by Tristen Ta. Published August 15, 2026; updated August 15, 2026.

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