Clinical evidence reference
Tesamorelin
Tesamorelin is a synthetic analogue of human growth hormone-releasing hormone (GHRH)[1,10]. In the United States it is a prescription medicine, approved by the FDA in 2010 for one use: reducing excess abdominal fat in adults with HIV who have lipodystrophy[3,1].
By Tesamorelin.app editorial teamSources reviewed How we source
Key facts
What the evidence covers
The approval rests on two 26-week phase 3 trials in adults with HIV and excess abdominal fat. Both measured visceral adipose tissue by CT as the primary endpoint and compared tesamorelin with placebo[1,5,7].
Later, smaller randomized studies measured liver fat in people with HIV[8,9]. Others studied populations outside the approved indication, such as obesity without HIV or cognition in older adults. Those results are not approved uses.
The label also notes that the effect on visceral fat was not maintained after treatment stopped in the extension phase, and that long-term cardiovascular safety has not been established[1,6].
Limitations of use (FDA label)
- Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
- EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.
- There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.
Quoted from the EGRIFTA WR prescribing information[1].
Research tools
- Clinical Trial Explorer11 registered trials with populations, controls, endpoints, results as reported, limitations and evidence grades.Open →
- Evidence ComparisonEach study's own estimate and confidence interval, side by side. Nothing pooled.Open →
- Mechanism ExplorerStep through the GHRH receptor pathway, from receptor binding to IGF-1, with a source for each step.Open →
- Regulatory Timeline14 dated FDA and labeling events, each linked to its primary record.Open →
Research guides
- What is tesamorelin?A sourced definition of tesamorelin: a synthetic growth hormone-releasing hormone analogue, its structure, receptor target and regulatory status.
- Tesamorelin mechanism of actionAn interactive, cited walkthrough of the GHRH receptor pathway tesamorelin acts on, from receptor binding to growth hormone release and IGF-1.
- Tesamorelin side effects and safetyTesamorelin adverse reactions, warnings and contraindications as reported in FDA prescribing information and clinical trials, with the evidence limits.
- Tesamorelin FDA approvalThe FDA-approved indication for tesamorelin, its limitations of use, and a dated regulatory timeline built from Drugs@FDA and current labeling.
- Tesamorelin vs ipamorelinHow tesamorelin and ipamorelin differ: receptor targets, structure, regulatory status and the size of each human evidence base, from primary sources.
- Tesamorelin molecular dataTesamorelin's amino-acid sequence, molecular formula, molecular weight, registry identifiers and structural modification, each linked to its source.
- Tesamorelin publicationsAn annotated bibliography of peer-reviewed tesamorelin publications used on this site, with PubMed and DOI links, study type and what each paper measured.
- Research methodologyHow this site selects sources, extracts trial data, grades evidence and handles uncertainty.
References
- 1.EGRIFTA WR (tesamorelin) for injection, Prescribing Information. Revised 03/2025; DailyMed SPL version 2 (published 2026-08-03). DailyMed · accessed 2026-11-11
- 2.U.S. Food and Drug Administration. Drugs@FDA: application 022505 (EGRIFTA), approval history and supplements. Drugs@FDA · accessed 2026-11-11
- 3.U.S. Food and Drug Administration. Approval letter, NDA 022505, EGRIFTA (tesamorelin for injection). November 10, 2010. FDA approval letter (PDF) · accessed 2026-11-11
- 4.U.S. Food and Drug Administration. Supplement approval letter, BLA 022505/S-020 (EGRIFTA WR). March 25, 2025. FDA letter (PDF) · accessed 2026-11-11
- 5.Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357:2359-70. PubMed · PMID 18057338 · doi:10.1056/NEJMoa072375 · accessed 2026-11-11
- 6.Falutz J, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22:1719-28. PubMed · PMID 18690162 · doi:10.1097/QAD.0b013e32830a5058 · accessed 2026-11-11
- 7.Falutz J, 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 Acquir Immune Defic Syndr. 2010;53:311-22. PubMed · PMID 20101189 · doi:10.1097/QAI.0b013e3181cbdaff · accessed 2026-11-11
- 8.Stanley TL, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312:380-9. PubMed · PMID 25038357 · doi:10.1001/jama.2014.8334 · accessed 2026-11-11
- 9.Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. 2019;6:e821-e830. PubMed · PMID 31611038 · doi:10.1016/S2352-3018(19)30338-8 · accessed 2026-11-11
- 10.PubChem Compound Summary for CID 16137828, Tesamorelin. National Center for Biotechnology Information. PubChem · accessed 2026-11-11
- 11.UniProtKB P01286. Somatoliberin (GHRH), Homo sapiens. UniProt · accessed 2026-11-11