Tesamorelin
Tesamorelin is an approved GHRH analogue used specifically to reduce excess visceral (abdominal) fat in adults with HIV-associated lipodystrophy. Its approval rested on two pivotal Phase 3 randomized trials, and it has since been studied for non-alcoholic fatty liver disease in people with HIV. It is not approved for general weight loss, bodybuilding, or anti-aging use, and its FDA-approved indication is narrow.
Mechanism
In plain terms, tesamorelin tells the pituitary gland to release more of the body's own growth hormone. Technically, it is a stabilized analogue of human GHRH that binds the GHRH receptor on anterior-pituitary somatotrophs, stimulating synthesis and pulsatile release of endogenous growth hormone and secondarily raising insulin-like growth factor 1 (IGF-1); in HIV-associated lipodystrophy this preferentially reduces visceral adipose tissue.
Regulatory Status by Region
- United States (FDA)Approved. Egrifta (tesamorelin) approved in November 2010 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy; reformulated products (Egrifta SV, Egrifta WR) were subsequently approved for the same indication.
- Australia (TGA)Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved tesamorelin product in Australia.
- European Union (EMA)No EMA marketing authorisation; tesamorelin is not an approved medicine in the European Union.
- WADAProhibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth-hormone-releasing factors, including GHRH and its analogues such as tesamorelin, are prohibited. Athletes require a therapeutic use exemption.
Key Studies
- Metabolic Effects of a Growth Hormone-Releasing Factor in Patients with HIV (Falutz et al.) (N Engl J Med 2007;357:2359-2370; DOI 10.1056/NEJMoa072375; PMID 18057338)
- Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial (Stanley et al.) (Lancet HIV 2019)
Related Clinical Trials
- Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)Phase 2 · Recruiting
- Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIVPhase 2 · Recruiting
- Growth Hormone Dynamics and Cardiac Steatosis in HIVN/A · Completed
- Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular RiskPhase 2 · Completed
- Tesamorelin to Improve Functional Outcomes After Peripheral Nerve InjuryPhase 2 · Recruiting
- Body Composition and Adipose Tissue in HIVPhase 4 · Terminated
- The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive ImpairmentPhase 1 · Completed
- Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected PersonsPhase 2 · Completed