18+ · Research Use Only · Not for Human Consumption
Regulation answer
Is tesamorelin FDA approved?
Yes, in the United States, for one indication. As of 23 September 2026, tesamorelin is US FDA approved as a branded medicine to reduce excess abdominal fat in adults with HIV and lipodystrophy. In the European Union it is not approved: the application was withdrawn in 2012. Its Philippine registration could not be read.
Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.
Updated 23 September 2026
01
United States
US FDA: "Approved for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy". Drugs@FDA records Egrifta (BLA022505, approved 10 November 2010). The label also states that it is not indicated for weight loss management.
02
European Union
EMA: "Not approved". The application for Egrifta (EMEA/H/C/002427) was withdrawn on 21 June 2012; no marketing authorisation was granted.
03
Philippines and the evidence
A search of fda.gov.ph for "tesamorelin" on 23 September 2026 returned no advisory, and the registration record could not be read from the verification portal.
The Research Desk rates tesamorelin's evidence as phase 3 human, from phase 3 trials in adults with HIV and excess visceral fat; the results and adverse events are on the Trial Explorer.
04
The trial behind the approval
In Tesamorelin phase 3 (Falutz, NEJM 2007), a phase 3 trial of tesamorelin in adults with HIV and abdominal fat accumulation (86% men) (n=412), the visceral adipose tissue was -15.2% on 2 mg over 26 weeks, against +5.0% on placebo (Falutz J et al. N Engl J Med 2007 (tesamorelin phase 3)).
In a 12-month randomised, placebo-controlled trial of 61 people with HIV and fatty liver disease, with no phase stated, tesamorelin reduced liver fat fraction by an absolute 4.1 percentage points more than placebo.
05
Side effects reported
In a 20-week phase 2 trial in older adults, mild adverse events were reported by 68% on tesamorelin against 36% on placebo.
In a 6-month trial of 50 people with HIV, fasting glucose rose 9 mg per decilitre on tesamorelin against 2 on placebo at 2 weeks; the difference was not significant at 6 months.
This is general information, not legal advice.
Sources
Where every figure comes from
- US FDA record for Tesamorelin · checked 23 September 2026
- EMA record for Tesamorelin · checked 23 September 2026
- FDA Philippines site search, tesamorelin · checked 23 September 2026
Last reviewed 23 September 2026