Tesamorelin
Growth hormone-releasing factor (GHRF) analogue
Status
Approved
FDA approved tesamorelin in 2010 (Egrifta, now sold as Egrifta SV and the Egrifta WR formulation approved in 2025) to reduce excess abdominal fat in adults with HIV and lipodystrophy, and Health Canada approved it in 2014, but the EU application was withdrawn in 2012 after regulators raised long-term safety concerns.
Evidence
Strong
Two placebo-controlled phase 3 trials with 806 patients combined showed consistent reductions in visceral fat, although long-term cardiovascular benefit has not been shown.
In sport
WADAProhibited (WADA)
Tesamorelin is a stabilised version of the body's full growth hormone-releasing hormone. It is FDA-approved as a daily injection to reduce excess deep belly (visceral) fat in adults with HIV-associated lipodystrophy, a fat redistribution problem linked to HIV treatment.
Structure
44 residuesPoint at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.
Sequence as text
trans-3-hexenoyl-Y-A-D-A-I-F-T-N-S-Y-R-K-V-L-G-Q-L-S-A-R-K-L-L-Q-D-I-M-S-R-Q-Q-G-E-S-N-Q-E-R-G-A-R-A-R-L-NH2
What it is used for
- Reduction of excess abdominal fat in adults with HIV and lipodystrophy (approved)
- Fatty liver disease (NAFLD) in people with HIV (studied)
- General weight loss, muscle building or anti-ageing (claimed, unproven)
How it works
Tesamorelin binds and activates GHRH receptors on the pituitary with potency similar to the natural hormone, increasing the body's own pulses of growth hormone and raising IGF-1. Growth hormone promotes the breakdown of stored fat, with the clearest effect on visceral fat around the abdominal organs, while fat under the skin is largely unchanged. It is cleared from the blood within minutes, so it works through daily pulses rather than continuous exposure.
How strong the evidence is
Strong
In the first phase 3 trial, 412 adults with HIV and abdominal fat accumulation were randomized to tesamorelin or placebo for 26 weeks: visceral fat fell 15.2% versus a 5.0% rise on placebo, with lower triglycerides (Falutz 2007, NEJM). A pooled analysis of two phase 3 trials (806 patients) confirmed the effect, showed it was maintained to 52 weeks, and found no clinically meaningful glucose changes, although IGF-1 rose substantially (Falutz 2010). In a 61-person randomized trial in people with HIV and fatty liver, tesamorelin produced a 37% relative reduction in liver fat after one year (Stanley 2019, Lancet HIV).
Risks and side effects
- Raised IGF-1; the label advises monitoring and considering stopping if levels stay very high
- Fluid retention with swelling, joint pain and carpal tunnel symptoms
- Glucose intolerance and increased risk of diabetes
- Hypersensitivity and injection-site reactions
- Not for use in pregnancy, active cancer or pituitary disorders
Label dosing
Label (Egrifta WR): 1.28 mg injected under the skin of the abdomen once daily.
Regulatory status
| Region | Year | Approved for |
|---|---|---|
| USFDA | 2010 | Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy |
| CAHealth Canada | 2014Withdrawn 2022 | Excess visceral abdominal fat in treatment-experienced adults with HIV and lipodystrophy |
Status by country
| Jurisdiction | Status | Source |
|---|---|---|
| USUnited States | Authorised medicine | Source 2 |
| EUEuropean Union | No authorised medicine | Source 6 |
| UKUnited Kingdom | No authorised medicine | Source 10 |
| AUAustralia | No authorised medicine | Source 11 |
| CACanada | Withdrawn | Source 12 |
Trials of Tesamorelin to watch
TRIUMPH (tesamorelin)(opens the source in a new tab)
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Timeline
2028
2026
2022
- Withdrawn, CA (Health Canada)Excess visceral abdominal fat in treatment-experienced adults with HIV and lipodystrophy
2014
- Approved, CA (Health Canada)Excess visceral abdominal fat in treatment-experienced adults with HIV and lipodystrophy
2010
- Approved, US (FDA)Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy
Sources
- 01EGRIFTA WR (tesamorelin) for injection: prescribing information(opens the source in a new tab)
- 02EGRIFTA WR (tesamorelin) label(opens the source in a new tab)
- 03Metabolic effects of a growth hormone-releasing factor in patients with HIV(opens the source in a new tab)
- 04Effects of tesamorelin (TH9507) in HIV-infected patients with excess abdominal fat: a pooled analysis of two phase 3 trials with safety extension data(opens the source in a new tab)
- 05Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial(opens the source in a new tab)
- 06Ferrer Internacional, S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin)(opens the source in a new tab)
- 07Summary Basis of Decision for Egrifta (tesamorelin)(opens the source in a new tab)
- 08Somatoliberin (human GHRH) (P01286)(opens the source in a new tab)
- 09World Anti-Doping Code International Standard: Prohibited List 2026(opens the source in a new tab)
- 10MHRA Products: active substances beginning with T(opens the source in a new tab)
- 11Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab)
- 12Drug Product Database: Egrifta (DIN 02438712)(opens the source in a new tab)
Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.