Regulatory posture
Tesamorelin is FDA approved and marketed as Egrifta for the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Because an FDA approved product is available, compounding is restricted and generally permitted only under narrow, defined conditions. It is not a controlled substance under the DEA.
Mechanism, plain English
Tesamorelin is a stabilized synthetic form of growth hormone releasing hormone, the natural signal that tells the pituitary gland to release growth hormone. By boosting the body's own growth hormone, it raises insulin-like growth factor 1 and helps reduce deep abdominal fat, called visceral fat. Its approved use targets the excess belly fat that can occur in people living with HIV.
Evidence landscape
Tesamorelin has a defined, trial-supported role in HIV-associated lipodystrophy and related visceral fat accumulation. A randomized placebo-controlled trial with a safety extension showed reductions in abdominal fat in people with HIV, supporting its approved indication. A randomized clinical trial reported reductions in both visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation. A later randomized, double-blind, multicenter trial found that tesamorelin reduced liver fat and limited fibrosis progression in people with HIV and non-alcoholic fatty liver disease. Evidence outside HIV-related indications is more limited, and effects can reverse when treatment stops.
Primary PubMed citations
- Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension , Falutz J et al, Journal of Acquired Immune Deficiency Syndromes, 2010. PMID: 20101189
- Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial , Stanley TL et al, JAMA, 2014. PMID: 25038357
- Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial , Stanley TL et al, Lancet HIV, 2019. PMID: 31611038
Citations selected from the PubMed literature. Every URL was checked at publication time. Scriptura's daily PubMed scan surfaces new studies for each compound as they index. See the regulatory and literature layers on the demo.
This is a plain English summary of the peer reviewed literature and current regulatory posture. It is not a substitute for a licensed clinician's judgment on a specific patient. It does not recommend dosing, cadence, or route. Where the literature is limited or preclinical, this page says so, so a prescriber can weigh marketing claims against what the trials actually show.