Tesamorelin — Research Dossier
Evidence grading
Mechanism
GHRH analogue
Stimulates endogenous pulsatile GH secretion
FDA approval
2010
HIV-associated lipodystrophy · Egrifta
Visceral fat reduction
15–18%
Phase 3 pooled · 26 weeks vs placebo
Trial participants
~816
Pooled across two pivotal Phase 3 trials
Tesamorelin sits at the top of this library's evidence ladder: the only FDA-approved peptide in the Nexyra catalogue, backed by pivotal Phase 3 trials. Its approval is also narrow — one indication, one population — which this dossier states plainly.
Tesamorelin is a stabilised synthetic analogue of human growth-hormone-releasing hormone (GHRH(1–44)). It binds pituitary GHRH receptors to stimulate the body's own pulsatile growth-hormone secretion, raising IGF-1 and shifting adipose metabolism toward reduced visceral fat — while preserving natural feedback regulation, unlike exogenous growth hormone.
It is marketed by Theratechnologies as Egrifta, and in subsequent formulations Egrifta SV and the weekly-reconstitution Egrifta WR. The distinction between Tesamorelin as a pharmaceutical-grade approved medicine and the research-grade material sold in this catalogue is addressed directly in the disclaimer section below.
“Tesamorelin produced statistically significant reductions in visceral adipose tissue of approximately 15–18% versus placebo at 26 weeks across the two pivotal Phase 3 trials in adults with HIV-associated lipodystrophy.”
— Falutz et al., N Engl J Med 2007; pooled Phase 3 analysis, JCEM 2010
The Phase 3 pivotal evidence
Two pivotal Phase 3, randomised, double-blind, placebo-controlled trials enrolled approximately 816 adults in total with HIV-associated lipodystrophy over 26 weeks. The primary endpoint in both trials was change in visceral adipose tissue (VAT) area measured by computed tomography imaging.
Key results (pooled across both pivotal trials)
- Visceral adipose tissue: approximately 15–18% reduction versus placebo at 26 weeks
- Waist circumference: statistically significant reduction versus placebo
- Triglycerides: improvement versus placebo
- Subcutaneous adipose tissue: no clinically meaningful change (effect is selective for visceral fat)
- Patient-reported body-image satisfaction: statistically significant improvement
The first pivotal trial was published in the New England Journal of Medicine (Falutz et al., 2007). The FDA approved tesamorelin in 2010 for the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy, under the brand name Egrifta (NDA 022505). This remains the sole approved indication.
Beyond the approved indication
Off-label research has examined tesamorelin's effect on hepatic fat. A 2019 randomised trial (Stanley et al., Lancet HIV) reported reductions in hepatic fat fraction and markers of liver inflammation in HIV-positive adults with non-alcoholic fatty liver disease over 12 months.
Research in non-HIV populations — including general visceral obesity, body composition, anti-ageing, and performance contexts — consists largely of small, short-duration studies. No large Phase 3 programme equivalent to the pivotal HIV trials exists for any of these uses. These applications are not approved by the FDA, EMA, or MHRA.
This dossier summarises published evidence only and does not endorse any off-label application.
Safety profile and regulatory status
The safety profile is well characterised from Phase 3 trials and post-marketing surveillance in the HIV-lipodystrophy population. Commonly reported adverse effects include:
- Injection-site reactions (erythema, pruritus, pain, swelling)
- Arthralgia and myalgia
- Peripheral oedema and fluid retention
- Elevated fasting glucose or worsening glycaemic control
- Paraesthesia
Tesamorelin is a prohibited substance under World Anti-Doping Agency (WADA) rules and is classified as a biologic under US law. It is prescription-only in all jurisdictions where it holds any regulatory status.
Regulatory status (as of 2026)
- United States — FDA-approved: Egrifta / Egrifta SV / Egrifta WR for HIV-associated lipodystrophy (NDA 022505).
- United Kingdom — Not approved by the MHRA. No licensed indication in the UK.
- European Union — Not approved by the EMA. No licensed indication in the EU.
What this evidence is — and isn’t
These trials studied pharmaceutical-grade Tesamorelin administered under medical supervision in controlled settings. The figures summarised in this dossier describe that published science only.
They are not outcomes associated with research-grade material, and not results attributable to any use of the product sold in this catalogue. Nothing here is an endorsement, recommendation, or instruction for human use.
Nexyra Lab Catalogue
This dossier covers published clinical research on Tesamorelin. Nexyra Lab supplies research-grade Tesamorelin for in vitro laboratory use.
View Tesamorelin in the Nexyra catalogue (research use only) →See also
References
- 1
Falutz J, Allas S, Blot K, et al. Metabolic effects of a growth hormone–releasing factor in patients with HIV-associated lipodystrophy. N Engl J Med. 2007. https://pubmed.ncbi.nlm.nih.gov/18057338/
- 2
Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Clin Endocrinol Metab. 2010.
- 3
Stanley TL, Fourman LT, Feldpausch MN, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. 2019.
- 4
Theratechnologies Inc. Egrifta SV (tesamorelin for injection) — US Prescribing Information. FDA / Theratechnologies 2023. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505
Research & Laboratory Use Only
This dossier is compiled for research planning and educational purposes only. It summarises published scientific literature and does not constitute medical advice, dosing guidance, or a therapeutic claim. All Nexyra Lab products are for research purposes only and are not for human or veterinary use. Nothing in this document should be interpreted as recommending, endorsing, or facilitating the self-administration of any compound.
A one-time legal review of this template and disclaimer is recommended before the Journal section is made publicly accessible, given the health-adjacent nature of this content.