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All research profiles

GH secretagogue

Tesamorelin

Prepared by the ezGLP team. Sources last checked . Profile reviewed .

Routes represented in the knowledgebase: Subcutaneous (SubQ).

Educational overview

Tesamorelin is listed in the ezGLP knowledgebase under GH secretagogue. Evidence and regulatory status can vary by formulation, route, and jurisdiction.

Tesamorelin is a synthetic analogue of the full 44-amino-acid human growth hormone-releasing hormone (GHRH) carrying a trans-3-hexenoic acid group at the N-terminus that protects it from enzymatic cleavage. It belongs to the GHRH-analogue class with sermorelin and CJC-1295 and acts on pituitary GHRH receptors to increase pulsatile growth hormone secretion and, downstream, IGF-1, while preserving feedback regulation by IGF-1 and somatostatin. Developed by Theratechnologies, it is marketed as Egrifta and is currently the only GHRH analogue with an active marketing approval in any major jurisdiction.

Tesamorelin has the most substantial evidence base of any GH secretagogue. Falutz and colleagues reported two phase III randomised, placebo-controlled trials in 2010, enrolling more than eight hundred HIV-infected adults with abdominal lipohypertrophy, in which tesamorelin reduced visceral adipose tissue relative to placebo over twenty-six weeks, with the effect reversing after discontinuation. Clemmons and colleagues published a randomised trial in adults with type 2 diabetes in 2017 that found no clinically meaningful deterioration in glycaemic control. Later academic studies have examined effects on liver fat in HIV-associated non-alcoholic fatty liver disease and on cognition in older adults, but these remain investigational.

The FDA approved Egrifta in 2010 for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy, and later approved reformulations, Egrifta SV and Egrifta WR, for the same indication; the label carries warnings for glucose intolerance, fluid retention, hypersensitivity, and injection-site reactions and states that it is not indicated for weight loss. In the European Union the applicant withdrew its marketing application in 2012 after the CHMP could not conclude a positive benefit-risk balance, so tesamorelin is not authorised in the EU or the UK. The World Anti-Doping Agency names tesamorelin on its Prohibited List under section S2.2.4, banned at all times.

Egrifta is dispensed as a lyophilised powder in single-use or multi-dose vials that are reconstituted with the supplied sterile water for subcutaneous injection; storage and in-use limits differ between presentations, with some kept at room temperature before reconstitution and others requiring refrigeration, so the specific product label governs handling. The peptide has a short half-life, reported at roughly half an hour, and the label describes once-daily administration. Compounded tesamorelin, including fixed-ratio blends with ipamorelin, is an unapproved product that follows the pharmacy's beyond-use dating instead. Dose logs typically record the presentation, lot number, reconstitution date, and storage temperature, and, because the effect on visceral fat reverses after stopping, start and stop dates.

Category
GH secretagogue
Routes represented
Subcutaneous (SubQ)
Approximate library half-life
0.5 hours; formulation-dependent and not dosing guidance
Storage context
Follow the dispensed product or pharmacy label; storage and beyond-use time vary by formulation.

Published literature

Safety evidence

Common or reported: edema, joint or muscle pain, tingling or carpal-tunnel symptoms, headache, injection-site reactions.

Serious or important: intracranial hypertension, glucose intolerance or diabetes, adrenal insufficiency, pancreatitis, malignancy-related warnings.

Safety evidence source

Interaction evidence

These are general, pairwise evidence notes. Green identifies the potential-synergy category, while Lv3/Lv2/Lv1 communicates evidence strength; it does not guarantee benefit or cancel a safety warning.

With glucocorticoid replacement

Safety flag

GH-axis stimulation can reduce cortisone-to-cortisol conversion and unmask or worsen adrenal insufficiency.

Interaction evidence source

With glucose-lowering medicines

Safety flag

GH-axis stimulation can reduce insulin sensitivity and alter glucose control.

Interaction evidence source

With another GH/IGF-axis medicine

Safety flag

Duplicate GH/IGF-axis stimulation may amplify IGF-1 elevation, edema, joint symptoms, and glucose intolerance.

Interaction evidence source

Common questions

Is tesamorelin FDA approved?

Yes, for one indication. The FDA approved Egrifta (tesamorelin for injection) in 2010 for reducing excess abdominal fat in HIV-infected adults with lipodystrophy, and the reformulated Egrifta SV and Egrifta WR carry the same indication. The label states that tesamorelin is not indicated for weight loss and that its effect on cardiovascular outcomes has not been established. Any other use, including compounded tesamorelin for body composition in people without HIV, is off-label or unapproved.

Is tesamorelin approved in Europe?

No. Ferrer Internacional submitted a centralised marketing authorisation application for Egrifta to the European Medicines Agency in 2011 and withdrew it in June 2012 after the Committee for Medicinal Products for Human Use indicated that the data did not allow it to conclude on a positive benefit-risk balance, partly because excess abdominal fat from lipodystrophy was difficult to distinguish from obesity in practice. Tesamorelin has not been authorised in the EU or the UK since.

What is the difference between tesamorelin and sermorelin?

Both are GHRH analogues acting on the same pituitary receptor. Sermorelin is the 29-amino-acid active fragment of GHRH and was approved for paediatric growth hormone deficiency before being discontinued in 2008, whereas tesamorelin is a stabilised full-length 44-amino-acid analogue that remains FDA-approved for HIV-associated abdominal fat. Tesamorelin has phase III trial data in more than eight hundred adults; sermorelin's adult evidence is limited to small studies.

Does tesamorelin affect blood sugar?

It can. Because growth hormone opposes insulin action, the Egrifta label warns of glucose intolerance and advises monitoring of glycaemic status, and phase III trials recorded small increases in fasting glucose and HbA1c in some participants. Clemmons and colleagues' 2017 randomised trial in adults with type 2 diabetes found no clinically significant worsening of glycaemic control over twelve weeks, but the label continues to flag diabetes as a consideration.

Is tesamorelin banned in sport?

Yes. The World Anti-Doping Agency Prohibited List names tesamorelin as an example of a growth hormone-releasing hormone analogue under section S2.2.4, growth hormone-releasing factors, together with sermorelin and CJC-1295. Section S2 substances are prohibited at all times, in and out of competition, and are treated as non-specified substances; an athlete with a medical need would require a therapeutic use exemption.

Further reading

Summarised from published literature for reference only, with citations to the source. Evidence is graded as reported and is not a recommendation to combine, dose, or use any compound.

For personal tracking and education only. Not medical advice, diagnosis, or treatment, and not a medical device. Peptides may be prescription-only or unapproved where you live. Consult a licensed healthcare professional.