Tesamorelin is not widely approved in Europe for routine clinical use in the same way it is in the United States. Nevertheless, it remains available in some research settings, compounding pharmacies, and specialised medical facilities, depending on the country and local regulations. Tesamorelin is best known as the active substance in Egrifta SV®, which was approved by the US Food and Drug Administration (FDA) for the reduction of excess visceral fat in adults with HIV-associated lipodystrophy [1–3]. In Europe, tesamorelin has not received broad authorisation from the European Medicines Agency (EMA) for standard prescribing within the European Union, meaning its availability remains more limited than in the USA.
References
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- Traynor, K. (2010). FDA approves tesamorelin for HIV-related lipodystrophy. American Journal of Health-System Pharmacy, 67(24), 2082–2082. https://doi.org/10.2146/news100082
- Falutz, J., Mamputu, J. C., Potvin, D., Moyle, G., Soulban, G., Loughrey, H., Marsolais, C., Turner, R., & Grinspoon, S. (2010). Effects of tesamorelin (TH9507), a growth hormone-releasing factor analogue, in human immunodeficiency virus-infected patients with excess abdominal fat: A pooled analysis of two multicentre, double-blind placebo-controlled phase 3 trials with safety extension data. The Journal of Clinical Endocrinology & Metabolism, 95(9), 4291–4304. https://doi.org/10.1210/jc.2010-0490
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- Stanley, T. L., Fourman, L. T., Feldpausch, M. N., Purdy, J., Zheng, I., Pan, C. S., Agyapong, G., Torriani, M., Chung, R. T., & Grinspoon, S. K. (2019). Effect of tesamorelin on non-alcoholic fatty liver disease in HIV-positive individuals: A randomised, double-blind, multicentre study. The Lancet HIV, 6(12), e821–e830. https://doi.org/10.1016/S2352-3018(19)30338-8
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- Makimura, H., Murphy, C. A., Feldpausch, M. N., & Grinspoon, S. K. (2014). Effects of tesamorelin on phosphocreatine recovery in obese subjects with reduced GH. The Journal of Clinical Endocrinology & Metabolism, 99(1), 338–343. https://doi.org/10.1210/jc.2013-3436
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- Stanley, T. L., Fourman, L. T., Wong, L. P., et al. (2021). Growth hormone-releasing hormone reduces circulating markers of immune activation in parallel with effects on hepatic immune pathways in HIV and NAFLD. Clinical Infectious Diseases, 73(4), 621–630. https://doi.org/10.1093/cid/ciab019
- Badran, A. S., Helal, A., Shata, K. S., & Ayesh, H. (2026). Body composition, hepatic fat, metabolic, and safety outcomes of tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomised controlled trials. Obesity Research & Clinical Practice, 20(1), 2–12. https://doi.org/10.1016/j.orcp.2026.01.002