Our Tesamorelin pen holds 32 mg in 3 ml as a pre-loaded multi-dose pen. Tesamorelin occupies an unusual position in this catalogue: it is the compound with the most conventional clinical development history behind it, approved as Egrifta for a specific indication in a specific population. That makes it the one where the distinction between “what the trials showed” and “what this pen is” needs stating most carefully. Batch certificates are published on our certificates page.
The trial evidence is real, well-defined and narrower than it is usually presented. Spotlight on tesamorelin in HIV-associated lipodystrophy. PMID 22050344; Clinical Review Report: Tesamorelin (Egrifta). PMID 30920787; Efficacy and safety of tesamorelin in people living with HIV with lipodystrophy: systematic review and meta-analysis. PMC13428105; ClinicalTrials.gov NCT00123253
What tesamorelin is
A synthetic analogue of human growth-hormone-releasing hormone, sometimes called growth hormone-releasing factor. It stimulates the synthesis and release of the body’s own growth hormone, acting on the GHRH receptor, rather than supplying growth hormone directly. It is the same mechanism class as CJC-1295 and sermorelin.
Unlike those two, it is short-acting. Its trials used daily dosing, mirroring the natural pulse rather than producing the sustained multi-day elevation a DAC-modified analogue does. That difference is set out at Tesamorelin vs CJC-1295.
What the trials measured, precisely
Two 26-week randomised controlled trials studied tesamorelin in patients with HIV-associated central fat accumulation. They reported a reduction in visceral adipose tissue, the fat around the organs, without a clinically significant effect on subcutaneous adipose tissue. That distinction is the finding, not a footnote.
Patients who continued into the 52-week extension phases maintained the visceral reduction. Patients who discontinued reaccumulated it. The effect was therefore contingent on continued administration rather than persistent afterwards.
A later meta-analysis of randomised controlled trials reported improvements in body composition, hepatic fat, lean body mass and IGF-1 in this population, without serious adverse effects or disturbance of glucose control. The lean-mass finding is why it appears on the muscle goal page.
Who those trials studied
This is where most summaries lose the plot. The approved indication is the reduction of excess abdominal fat in patients with HIV-associated lipodystrophy: a specific metabolic condition, in a specific population, with a specific fat-distribution problem.
Trial results in that population do not establish outcomes in people without the condition, a caveat we repeat where it is listed under weight loss. A compound that reduces pathological visceral fat accumulation in lipodystrophy has not thereby been shown to do anything comparable in a healthy adult, and no trial has tested that. Any page presenting tesamorelin as a general body-composition compound is extending the evidence past where it goes.
Reported adverse events
The clinical record is more complete here than for most compounds in this catalogue. Treatment-emergent serious adverse events occurred in fewer than 4% of patients over 26 weeks of therapy. The events reported were largely injection-site reactions, or effects known to be associated with growth hormone therapy generally: joint pain, headache and peripheral oedema.
That is a genuine safety dataset from supervised clinical use, and it is worth more than the absence of reports that characterises most unapproved compounds. It still describes 26 weeks in one patient population under monitoring.
Approval status, stated exactly
Tesamorelin was approved as Egrifta for HIV-associated lipodystrophy. The approved medicine is a specific product at a specific strength in a specific formulation, supplied through licensed pharmacies against a prescription, with an approved dose and post-marketing surveillance behind it.
This pen is not that product. We supply tesamorelin as a pre-loaded pen with its batch certificate, and nothing else that surrounds the medicine comes with it. Egrifta holds FDA approval in the United States; it has no EMA marketing authorisation, so in the EU tesamorelin sits outside the approved supply route altogether. Why this distinction matters across our range is covered at why these compounds are not EMA-authorised.
Related: what is tesamorelin?, growth hormone peptides.
