Tesamorelin

What it is

Tesamorelin is a stabilized synthetic analog of growth-hormone-releasing hormone (GHRH) that stimulates the pituitary to release growth hormone; it is marketed as Egrifta (and reformulated versions).S1

Marketed as

Within its approved use, tesamorelin is marketed for HIV-associated lipodystrophy. Far more broadly, it is promoted off-label for visceral fat loss, body recomposition, and anti-aging — these broader uses are marketing claims and off-label promotion, not approved indications.S1

Regulatory status (US)

Tesamorelin is FDA-approved, but its only approved indication is the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy.S1 Reformulated versions (including a longer-interval preparation) have been approved for the same indication.S1 Use for general fat loss or anti-aging is off-label.S1

Around the world

Tesamorelin's regulated availability centers on its approved lipodystrophy indication; outside that narrow use it circulates through off-label and compounded channels rather than as a broadly licensed anti-aging drug.S1

Evidence

In its approved indication, controlled trials support a reduction in visceral adipose tissue in adults with HIV-associated lipodystrophy — the basis of its label.S1 Evidence for the off-label fat-loss and anti-aging uses is not the basis of any approval and should not be presented as established.S1

Anti-doping

As a GHRH analog / growth-hormone secretagogue, tesamorelin falls under WADA S2 (peptide hormones, growth factors, related substances and mimetics) and is prohibited at all times.S2

Safety

Within its approved use, tesamorelin's safety is governed by its FDA labeling, which includes cautions relating to growth-hormone-axis stimulation.S1 Off-label and compounded use falls outside that regulated framework.S1

What's changing

No specific regulatory change is confirmed here; the standing distinction to track is approved lipodystrophy use versus off-label anti-aging promotion.S1