Tesamorelin
Egrifta
Tesamorelin is a synthetic analog of growth-hormone-releasing hormone (GHRH, also called GRF): the full 44-amino-acid sequence of human GRF with a hexenoyl (C6) moiety attached at the N-terminal tyrosine. It is FDA-approved (Egrifta; original U.S. approval 2010) for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. The label states it is not indicated for weight-loss management and that long-term cardiovascular safety has not been established. In a 26-week phase-3 trial in 412 people with HIV and abdominal fat accumulation, daily 2 mg subcutaneous tesamorelin reduced CT-measured visceral adipose tissue (VAT) by 15.2% versus a 5.0% increase on placebo, and improved triglycerides and the cholesterol-to-HDL ratio. A pooled analysis of two phase-3 trials (806 patients) found a 15.4% treatment effect on VAT at 26 weeks with no significant change in abdominal subcutaneous fat; reductions were maintained to 52 weeks in those who continued treatment, and were rapidly lost in those switched to placebo. Outside the approved indication, a 12-month randomized trial in people with HIV and non-alcoholic fatty liver disease (NAFLD) found a 37% relative reduction in hepatic fat fraction measured by MR spectroscopy, and a 20-week controlled trial of 1 mg/day in older adults (with and without mild cognitive impairment) reported a favorable effect on executive function. These uses are investigational. Because tesamorelin raises GH and IGF-1, the label calls for IGF-1 monitoring and glucose evaluation before and during therapy.
Source references
Specifications
| Dose Range | Clinical trials used 2 mg once daily; current labeled dose for the EGRIFTA WR formulation is 1.28 mg once daily (formulations are not interchangeable) |
| Origin / Manufacturer | Synthetic |
| Regulatory Status | FDA-approved (Egrifta) |
| Active Components | Tesamorelin acetate |
| Storage | EGRIFTA WR vial: room temperature 20–25°C, protected from light (per current FDA labeling) |
| Form Factor | Lyophilized vial with diluent |
Frequently Asked Questions
Sources & References
Every clinical claim on this page traces to a primary peer-reviewed source.
- 1Falutz 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;357(23):2359-70. doi:10.1056/NEJMoa072375 PMID:18057338
- 2Stanley TL, Fourman LT, Feldpausch MN, et al.. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet HIV. 2019;6(12):e821-e830. doi:10.1016/S2352-3018(19)30338-8 PMID:31611038
- 3Baker LD, Barsness SM, Borson S, et al.. Effects of growth hormone–releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Archives of Neurology. 2012;69(11):1420-9. doi:10.1001/archneurol.2012.1970 PMID:22869065
- 4Falutz J, Mamputu JC, Potvin D, et al.. 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. The Journal of Clinical Endocrinology and Metabolism. 2010;95(9):4291-304. doi:10.1210/jc.2010-0490 PMID:20554713
- 5Falutz 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. Journal of Acquired Immune Deficiency Syndromes. 2010;53(3):311-22. doi:10.1097/QAI.0b013e3181cbdaff PMID:20101189
- 6U.S. Food and Drug Administration. EGRIFTA WR (tesamorelin) for injection — Prescribing Information (BLA 022505, revised 3/2025). Drugs@FDA. 2025.
- 7U.S. Food and Drug Administration. Drugs@FDA: BLA 022505 EGRIFTA (tesamorelin acetate). Drugs@FDA. 2025.
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