Tesamorelin: clinical evidence record
Also known as: Egrifta, TH9507, Trans-3-hexenoyl-GHRH (1-44)
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-05-22
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AI-friendly summary · Tesamorelin
FDA-approved as Egrifta in 2010 for reduction of excess abdominal fat in HIV-associated lipodystrophy. Phase 3 RCTs (Falutz et al.) report visceral adipose tissue reduction. Not licensed in the UK.
Mechanism of action
How Tesamorelin works
Synthetic 44-amino-acid GHRH analogue with a trans-3-hexenoic acid modification at the N-terminus that protects against dipeptidyl peptidase IV degradation, extending half-life. Stimulates pituitary GH release at the GHRH receptor.
Top peer-reviewed citations
Selection of the most-cited peer-reviewed literature on Tesamorelin. Where a verified PMID or DOI is shown, the citation links to the original record. Other citations list the title, authors, journal and year so the reader can locate the paper through the journal index or the PubMed search linked below. PeptideClear publishes editorial commentary, not clinical guidance.
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Metabolic effects of a growth hormone-releasing factor in patients with HIV
Falutz J, Allas S, Blot K, et al.. The New England journal of medicine, 2007.
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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
Falutz J, Mamputu JC, Potvin D, et al.. Journal of acquired immune deficiency syndromes (1999), 2010.
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Growth Hormone Releasing Hormone Reduces Circulating Markers of Immune Activation in Parallel with Effects on Hepatic Immune Pathways in Individuals with HIV-infection and Nonalcoholic Fatty Liver Disease
Stanley TL, Fourman LT, Feldpausch MN, et al.. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021.
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Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin
Stanley TL, Falutz J, Marsolais C, et al.. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012.
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Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data
Falutz J, Potvin D, Mamputu JC, et al.. The Journal of clinical endocrinology and metabolism, 2010.
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Effects of growth hormone–releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial
Baker LD, Barsness SM, Borson S, et al.. Archives of neurology, 2012.
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Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity
Ellis RJ, Vaida F, Hu K, et al.. The Journal of infectious diseases, 2025.
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Non-clinical pharmacology and safety evaluation of TH9507, a human growth hormone-releasing factor analogue
Ferdinandi ES, Brazeau P, High K, et al.. Basic & clinical pharmacology & toxicology, 2007.
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Effects of tesamorelin on inflammatory markers in HIV patients with excess abdominal fat: relationship with visceral adipose reduction
Stanley TL, Falutz J, Mamputu JC, et al.. AIDS (London, England), 2011.
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Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV
Fourman LT, Czerwonka N, Feldpausch MN, et al.. AIDS (London, England), 2017.
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Injectable Peptides in Sports Medicine: A Structured Narrative Review of Evidence, Safety, and Antidoping Implications
Villegas Meza AD, Nocek M, Mitchell BC, et al.. JBJS reviews, 2026.
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Differing Presentations of Excess Visceral Abdominal Fat in People Living With HIV: Two Clinical Cases Highlighting Distinct Therapeutic Pathways With Tesamorelin and Glucagon-Like Peptide-1 Receptor Agonists
Beach R, Tims-Cook Z, McGary CS, et al.. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026.
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Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives
Renke G, Chinellato L. International journal of molecular sciences, 2026.
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Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
Mendias CL, Awan TM. Sports medicine (Auckland, N.Z.), 2026.
Full PubMed search: https://pubmed.ncbi.nlm.nih.gov/?term=tesamorelin.
Registered clinical trials
As of 2026-07-13, Tesamorelin has 21 interventional trials listed on ClinicalTrials.gov and the ISRCTN registry. Registration means a study is planned, running or completed. It is not evidence of efficacy, and a listing is not an endorsement.
Source: ClinicalTrials.gov and the ISRCTN registry, refreshed 2026-07-13. See the peptide clinical-trials tracker for the full picture across compounds.
UK regulatory status
Plain-English summary of where Tesamorelin sits under the four UK and international frameworks that govern peptide supply. Editorial commentary, not legal advice.
- Misuse of Drugs Act 1971: Not controlled under the Misuse of Drugs Act 1971.
- Psychoactive Substances Act 2016: Not scheduled under the Psychoactive Substances Act 2016.
- MHRA medicines classification: No UK marketing authorisation as a medicine.
- WADA Prohibited List: WADA Prohibited List S2 (peptide hormones, growth factors), prohibited at all times.
Risks and unknowns
What the literature does not yet show about Tesamorelin
Known concerns
- Tesamorelin has been studied in randomised human trials, which is a materially stronger position than most compounds on this site. Trial populations, endpoints and durations are still narrower than everyday use, so results describe the trial, not every person.
- 21 registered interventional trials exist for Tesamorelin and 3 are recruiting, so the evidence base is actively moving. A registration is not a result, and a recruiting trial has by definition not reported.
- Tesamorelin holds no UK marketing authorisation, so nothing you can buy has been assessed by a regulator, released by batch, or dispensed by an accountable pharmacy. Purity, dose accuracy and sterility rest entirely on the seller's own documentation.
- Tesamorelin appears on the WADA Prohibited List. For anyone subject to testing under UK Anti-Doping or an international federation, use is a violation, and detection windows for peptide metabolites extend well beyond the period of use.
Open questions in the literature
- Long-term outcomes beyond the duration of the published trials are unknown, and the published trials are considerably shorter than the periods over which people actually use these compounds.
- Interactions between Tesamorelin and prescribed medicines are not systematically studied, which matters most for anyone already on treatment for a long-term condition.
Regulatory note
No UK marketing authorisation as a medicine. Prohibited at all times under WADA S2 (peptide hormones, growth factors). The moment a UK seller or commentator makes a therapeutic claim, MHRA can treat the product as an unlicensed medicinal product.
Important: PeptideClear publishes encyclopedia commentary only and does not recommend human use. Speak to a UK-registered prescriber before any medical decision.
Related reading on PeptideClear
Frequently asked questions
What is the evidence level for Tesamorelin?
What is the UK regulatory status of Tesamorelin?
Has Tesamorelin been tested in human clinical trials?
Where can I read the source literature for Tesamorelin?
Last verified 2026-05-22. Editorial commentary, not legal or clinical advice. Citations without a linked identifier can be located through the PubMed search and the journal index.