Tesamorelin · Growth-hormone pathway, with an FDA approval

Tesamorelin is a synthetic analogue of growth-hormone-releasing hormone (GHRH). Unlike most peptides discussed on this site, it is an FDA-approved prescription medicine under the brand name Egrifta, approved in 2010 for the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy.

That approval is narrow. It is what makes tesamorelin unusual — a real safety and efficacy file exists — and also what people tend to misread: approval for one condition is not evidence for others.

In pharmacology studies tesamorelin stimulates the pituitary's own growth-hormone release, which in turn raises IGF-1. The approved trials measured visceral fat by CT scan in a specific patient population over 26–52 weeks. Any use outside that population is off-label and is a prescriber's decision, with monitoring of IGF-1 and glucose typically discussed.

Tesamorelin is FDA-approved (Egrifta / Egrifta SV / Egrifta WR) for HIV-associated lipodystrophy. Use for any other purpose is off-label. It is a prescription-only medicine; compounded versions exist in a grey area that a provider will explain. This is a general note, not legal advice.