Tesamorelin

Tesamorelin (TH9507, brand name) is a synthetic analogue of human growth hormone-releasing hormone (GHRH), developed by the Canadian company Theratechnologies. It contains all 44 amino acids of the natural hormone with a hexenoyl group (a short fatty-acid chain) attached to the first amino acid, which makes it resistant to breakdown by the enzyme DPP-4 (Ferdinandi et al., 2007). In 2010 the US FDA approved it for excess abdominal fat in adults with HIV-associated lipodystrophy (an abnormal redistribution of body fat). Approval rests on two phase 3 randomised, placebo-controlled trials in more than 800 people with HIV, in which deep abdominal (visceral) fat measured by CT fell more than with placebo and IGF-1 rose (Falutz et al., NEJM 2007; JCEM 2010). It is not licensed in the UK or EU: the European application was withdrawn in 2012 after the EMA's committee questioned whether the change in fat was clinically meaningful and raised concerns about high IGF-1 levels and missing long-term safety data. The US label states that long-term cardiovascular safety has not been established. Smaller trials have looked at liver fat in people with HIV. These research materials are not the licensed medicine. Supplied for laboratory research use only.