Evidence Grade A — Regulatory approved. 90 published studies. 24 registered clinical trials.
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Tesamorelin (sold as Egrifta SV) stimulates the pituitary gland to produce its own growth hormone, rather than replacing the hormone directly. It is approved specifically to reduce excess belly fat in people living with HIV who have lipodystrophy — a condition where antiretroviral treatment causes abnormal fat accumulation around the abdomen. It is the only approved GHRH analogue.
Tesamorelin is also known by these brand and alternate names:
90 published studies: 71 human, 1 animal, 2 in-vitro, 30 reviews
Tesamorelin is marketed as Egrifta SV (approved November 2010) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. In clinical trials, it reduced visceral fat by approximately 15% compared to a 5% increase with placebo, and this reduction was sustained with continued treatment.
Tesamorelin occupies a unique niche — it is the only approved GHRH analogue and the only medication specifically approved for HIV-associated lipodystrophy. Beyond its approved indication, it has attracted research interest for potential effects on liver fat, cognitive function, and peripheral neuropathy. Fat reduction reverses when treatment stops, and it is not approved for general weight loss or body composition purposes.
Instead of injecting growth hormone itself, tesamorelin works one step upstream: it activates the GHRH receptor on the pituitary gland, prompting the body to produce and release its own growth hormone in a natural pulsatile pattern. This is a key distinction from direct growth hormone replacement — the body's built-in feedback mechanisms remain intact, so growth hormone levels rise but stay within a more physiological range. The resulting growth hormone increase drives the breakdown of visceral (deep abdominal) fat that accumulates in HIV-associated lipodystrophy.
Clinical trials showed tesamorelin reduced deep abdominal (visceral) fat by approximately 15%, compared to a 5% increase with placebo. This reduction was maintained with continued treatment but reversed when treatment stopped. Tesamorelin occupies a unique niche as the only medication specifically approved for HIV-associated lipodystrophy. Beyond its approved use, tesamorelin has attracted significant interest in research on liver fat reduction (a trial showed meaningful decreases in liver fat in HIV patients with fatty liver) and in the longevity/anti-ageing space, where its physiological approach to growth hormone stimulation — preserving the body's natural pulsatile pattern and feedback mechanisms — is seen as potentially safer than direct growth hormone replacement. A key safety concern is the risk of new-onset diabetes.
PeptideTrace tracks 24 registered clinical trials for Tesamorelin sourced from ClinicalTrials.gov.
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Growth Hormone Dynamics and Cardiac Steatosis in HIV
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
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Health Canada Market Authorisation
FDA SUPPL 11
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Tesamorelin is a modified growth hormone-releasing hormone (GHRH) analogue consisting of the full 44-amino-acid GHRH sequence with a trans-3-hexenoic acid group attached at the N-terminus. This modification enhances stability and bioavailability.
Tesamorelin binds the GHRH receptor on anterior pituitary somatotrophs, stimulating endogenous GH synthesis and pulsatile release. Unlike exogenous rhGH, tesamorelin preserves physiological GH pulsatility and feedback regulation (somatostatin-mediated negative feedback remains intact). This means supraphysiological GH levels are self-limited, potentially reducing the risks associated with exogenous GH administration.
Tesamorelin is marketed as Egrifta/Egrifta SV (approved November 10, 2010) for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. In the pivotal LIPO-010 trial (N=412), tesamorelin reduced visceral adipose tissue by 15.2% versus a 5.0% increase with placebo (P<0.001). LIPO-011 confirmed sustained VAT reduction of 10.9% versus 0.6% at 26 weeks. New-onset diabetes occurred in 5% versus 1% (HR 3.3).
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Somatrogon is marketed as Ngenla (approved June 2023) for paediatric growth hormone deficiency in children aged 3 years and older. In the pivotal trial, once-weekly somatrogon produced growth rates equivalent to daily somatropin injections (10.1 cm/year versus 9.8 cm/year), confirming that reducing injection frequency does not compromise growth outcomes. Ngenla represents a meaningful advance for paediatric patients and their families, reducing injections from 365 to 52 per year. Treatment adherence has been a persistent challenge with daily growth hormone, and weekly dosing is expected to improve long-term outcomes through better compliance. Somatrogon competes directly with somapacitan (Sogroya), the other approved weekly growth hormone, creating a new generation of less burdensome treatment options.
Somapacitan is marketed as Sogroya (approved August 2020 for adult growth hormone deficiency; expanded April 2023 to paediatric growth hormone deficiency in children aged 2.5 years and older). It is the first once-weekly growth hormone approved for both adult and paediatric patients. In adults, clinical trials showed improvements in body composition including reduced truncal fat. In children, growth rates were comparable to daily somatropin. The albumin-binding approach provides predictable drug levels with lower peak-to-trough variation than some other long-acting growth hormone technologies. Sogroya competes with somatrogon (Ngenla) in the growing once-weekly growth hormone market, with both products expected to gradually replace daily injections as the standard of care.
ACE-031 has no marketing authorisation. A Phase I trial in healthy women showed increased lean mass and decreased fat mass. A Phase II trial in DMD (24 patients) showed lean body mass increases but was discontinued due to bleeding-related safety concerns (epistaxis, telangiectasias, and gum bleeding), likely caused by inhibition of BMP-9/10 vascular signalling. ACE-031 is a large fusion protein (~90 kDa), not a peptide. Its clinical development was halted. The non-selective ligand-trapping profile — capturing beneficial vascular signalling molecules alongside the intended muscle-growth targets — illustrates the challenge of targeting the TGF-beta superfamily. Acceleron subsequently developed more selective agents.
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