Tesamorelin

Definition

Tesamorelin is a synthetic analogue of growth hormone-releasing hormone, the hypothalamic peptide that signals the pituitary gland to release growth hormone. The molecule carries the full 44-amino-acid GHRH sequence with a trans-3-hexenoyl group at its amino terminus; the modification slows enzymatic degradation and extends activity after subcutaneous injection ^[1].

Stimulating the pituitary rather than replacing growth hormone directly preserves the body's own feedback control. Growth hormone and insulin-like growth factor 1 rise within a physiological pattern, which distinguishes GHRH analogues from injected growth hormone itself.

Evidence

The approval rests on randomized, placebo-controlled phase 3 trials in HIV-infected adults with excess visceral fat. In the trial reported by Falutz and colleagues, 404 patients received tesamorelin 2 mg or placebo daily by subcutaneous injection; visceral adipose tissue fell 10.9 percent in the treatment group against 0.6 percent with placebo over six months, and the reduction reached approximately 18 percent in patients who continued through a full year ^[1]. A pooled analysis of the two phase 3 studies and a long-term safety report are published separately ^{[2, 3]}.

Use outside the approved indication is not supported by registrational evidence. The trials enrolled HIV-infected patients with lipodystrophy; no phase 3 data exist for cosmetic fat reduction, athletic performance, or longevity applications.

Lawful access

Tesamorelin has been an approved drug in the United States since November 2010, first marketed as EGRIFTA. In March 2025 the FDA approved EGRIFTA WR, a more concentrated formulation reconstituted weekly rather than daily, which replaces the earlier EGRIFTA SV presentation ^[4]. It remains the only medication approved in the United States for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

The approved product is the lawful supply route. Under section 503A, a licensed pharmacy may not compound what is essentially a copy of a commercially available drug unless a prescriber documents a clinical difference that matters for an individual patient; a lower price does not qualify.

Related molecules

Tesamorelin is the approved drug of the GH secretagogues class, beside sermorelin, which is compounded under 503A, and CJC-1295, which has no lawful route; the molecule index records each posture. A contrasting case is BPC-157, a peptide with wide commercial visibility, no approved product, and no completed human trial.