PeptideTrace
ApprovedGHRH Analogue

Tesamorelin

Egrifta, Egrifta SV

A

Evidence Grade A — Regulatory approved. 85 published studies. 11 registered clinical trials.

11 trials85 studiesUSEUCA

Licensed Indications

  • HIV-Associated Lipodystrophy

User Experience Reports

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Overview

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.

Research Activity

85studies
Human 68
In-vitro 2
Reviews 27

85 published studies: 68 human, 0 animal, 2 in-vitro, 27 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Cancelled in Canada(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

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.

Mechanism of Action

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.

Research Summary

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.

Clinical Trials

NCT07481734Phase IIRecruiting

Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)

Hudson BiotechEndpoint: Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)Completion: 2028-02-17
NCT03826160N/ACompleted

Growth Hormone Dynamics and Cardiac Steatosis in HIV

Massachusetts General HospitalEndpoint: Intramyocardial lipid contentCompletion: 2022-04-19
NCT03150511Phase IIRecruiting

Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Johns Hopkins UniversityEndpoint: 3-point chuck pinch testCompletion: 2027-12-01
NCT03226821Phase IVCompleted

Body Composition and Adipose Tissue in HIV

Columbia UniversityEndpoint: Change in Hepatic Lipid ContentCompletion: 2025-04-30
NCT02572323Phase IICompleted

Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

University of California, San DiegoEndpoint: Change in Neurocognitive PerformanceCompletion: 2023-10-15
View all 11 trials on ClinicalTrials.gov →

Regulatory Timeline

2010
Regulatory

FDA ORIG 1

2011
Regulatory

FDA SUPPL 3

2011
Regulatory

FDA SUPPL 1

2013
Regulatory

FDA SUPPL 4

2014
Regulatory

FDA SUPPL 5

2015
Regulatory

FDA SUPPL 6

2015
Regulatory

FDA SUPPL 7

2015
Regulatory

Health Canada Market Authorisation

2019
Regulatory

FDA SUPPL 11

2019
Regulatory

FDA SUPPL 12

2019
Regulatory

FDA SUPPL 13

2024
Regulatory

FDA SUPPL 18

2025
Regulatory

FDA SUPPL 20

Related Compounds

Somatropin

Approved
Recombinant Human Growth Hormone

Somatropin has been available since the mid-1980s and is one of the most established peptide therapies. It is sold under numerous brand names including Genotropin, Humatrope, Norditropin, and Omnitrope (the first biosimilar approved in the US, 2006). Approved indications include childhood and adult growth hormone deficiency, Turner syndrome, children born small for gestational age, Prader-Willi syndrome, idiopathic short stature, and short stature from chronic kidney disease. Daily injection has been the main burden of somatropin therapy, particularly for paediatric patients who may require years of treatment. This has driven the development of once-weekly alternatives (somatrogon and somapacitan), which are gradually changing the treatment landscape. Annual treatment costs remain substantial, and concerns about misuse in anti-ageing and performance enhancement contexts are ongoing.

Somatrogon

Approved
Long-Acting Growth Hormone

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.

Sermorelin

Research Compound
GHRH Analogue

Sermorelin was formerly marketed as Geref (Serono) before voluntary withdrawal in 2009. The FDA confirmed the withdrawal was not related to safety or effectiveness. Research suggests it remains one of the most commonly prescribed compounds through US compounding pharmacies, particularly in anti-ageing and hormone optimisation clinics. Research suggests sermorelin's appeal lies in its more physiological approach to growth hormone enhancement compared to direct growth hormone injection — it preserves pulsatile release and feedback regulation. However, clinical evidence for its use in adults outside the original paediatric growth hormone deficiency indication is limited, and its very short half-life requiring daily injection is a practical limitation. Compounding pharmacy formulations are not subject to the same regulatory oversight as FDA-approved products.