Tesamorelin

What is tesamorelin approved to do?

Tesamorelin's label lists an initial US approval in 2010, and Egrifta WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy [1]. Its label states that Egrifta WR "is not indicated for weight loss management as it has a weight neutral effect" [1]. It is contraindicated in active malignancy, pregnancy and disruption of the hypothalamic-pituitary axis, and the label warns of increased risk of neoplasms and elevated IGF-1 levels [1].

What did the approval trials show?

Two randomized, placebo-controlled trials of 412 and 404 HIV-infected patients supported approval [1]. In the larger trial, mean visceral adipose tissue fell 15.2% with tesamorelin and rose 5.0% with placebo over 26 weeks, while IGF-I levels rose 81.0% in the tesamorelin group [2]. More tesamorelin patients withdrew because of an adverse event than placebo patients did [2].

Is compounded tesamorelin the same as Egrifta?

No. Compounded tesamorelin is not the FDA-reviewed Egrifta WR product. Under section 503A, a pharmacy may compound with a bulk substance that is a component of an FDA-approved drug product, and tesamorelin is a component of Egrifta WR; this page does not assess whether any compounded product meets section 503A's other conditions [3]. Tesamorelin is also named among the growth hormone-releasing factors prohibited at all times under the 2026 WADA list [4].