Approved (FDA / EMA)
FDA (U.S.): Approved (Nov 11, 2010, Egrifta) to reduce excess abdominal fat in adults with HIV and lipodystrophy; new formulations Egrifta SV and Egrifta WR (Mar 25, 2025). Not indicated for weight loss.
EMA (EU): Not approved: Ferrer withdrew the application in June 2012 because the CHMP considered that the data did not allow a positive benefit-risk balance to be concluded.
May harm the fetus: if pregnancy occurs it must be discontinued and a doctor consulted (FDA label for Egrifta WR).
Outside its indication (HIV with lipodystrophy), tesamorelin is promoted in 'anti-aging' and fat-loss clinics to raise growth hormone in people without HIV. That use is not approved or supported by trials demonstrating long-term benefit and safety in the general population; it raises IGF-1 and can worsen glucose. It has also been investigated (without approval) in HIV-associated fatty liver and in mild cognitive impairment.
2 mg/day subcutaneously. Prescription only and with a diagnosis of HIV lipodystrophy (approved indication).
52-week trial: 15-17.5% reduction in visceral fat. FDA-approved indication.
View the study (phase 3 RCT) →Raises IGF-1 to the physiological range by stimulating pulsatile endogenous GH release, without exceeding a ceiling.
View the study (phase 3 RCT) →Information, not medical advice. Scientific evidence reflects the quality of the studies.