Tesamorelin
A daily injection approved for one use: excess belly fat in adults with HIV-associated lipodystrophy. Its trials measured fat around the organs, and its label says it is not a weight-loss drug.
- U.S. status
- Approved as a brand only
- Approved only as Egrifta, for excess abdominal fat in adults with HIV-associated lipodystrophy. Its label says it is not indicated for weight loss. Egrifta became a biologic (BLA) on March 23, 2020, and FDA says compounded versions of these products do not qualify for the 503A or 503B compounding exemptions.
- FDA source, read September 2026.Also:FDA notice to compounders (March 23, 2020)Drugs@FDA, application 022505Egrifta WR label (DailyMed)
- Evidence cited here
- Weight: no cited study measured this, so no label
- Falutz 2007 (412 people) and Falutz 2010 (404 people) did not measure weight, so they count toward no label here. They are still listed with the studies below.
- Forms sold
- Brand only
- Compounded versions are not permitted, so we list no compounded seller or price.
1. What Tesamorelin is
Tesamorelin is a lab-made analog of growth-hormone-releasing hormone (GHRH), built on the hormone's 44-amino-acid sequence. It is approved as Egrifta to reduce excess abdominal fat in adults with HIV-associated lipodystrophy, a fat build-up seen during HIV treatment.
That approval is narrow, and its label says it is not indicated for weight loss management because its effect on weight is neutral. The trials tested the approved product in people with HIV.
Egrifta was first approved as a drug in 2010. On March 23, 2020, FDA deemed that approval a biologics license, one of a list of products it moved from drug to biologic that day. FDA told compounders that these products do not qualify for the 503A or 503B compounding exemptions. So only the brand-name product may be prescribed, and we list no compounded seller.
2. How it works
Tesamorelin binds the GHRH receptor on the pituitary gland, which releases growth hormone, and the liver answers with more IGF-1. In the trials, that shift came with less fat packed around the abdominal organs, called visceral fat, while fat under the skin of the belly and limbs did not change.
It is injected under the skin once a day. The reduction held only while people kept taking it, which the 12-month trial measured directly.
3. What the studies measured
The first large trial randomized 412 people with HIV and abdominal fat build-up, 86% of them men, to 2 mg daily or placebo for 26 weeks. On CT scans, visceral fat fell 15.2% on tesamorelin and rose 5.0% on placebo.
Triglycerides dropped by 50 mg/dL on tesamorelin, where placebo raised them by 9, and IGF-1 went up 81.0%. Glucose measures did not differ between groups, but more people on tesamorelin left the trial because of an adverse event.
A second trial followed 404 people with HIV for 12 months. Over the first six months visceral fat fell 10.9% on tesamorelin against 0.6% on placebo, and about 18% in those who stayed on it for a year. In people switched to placebo at six months, that improvement was rapidly lost.
4. What they did not measure
Both trials enrolled only people with HIV. None tested tesamorelin in people without HIV, or as a weight-loss treatment, so these results do not show it helps anyone else lose weight or belly fat.
Body weight was not the outcome. A drop in deep belly fat on a scan is not a lower number on the scale, and neither trial measured heart attacks, strokes or survival.
The studies behind this page
The evidence label above is computed from these papers: their design and how many people they enrolled.
- Randomized trial
412 people
Counts toward no label
Visceral fat on CT fell 15.2% on tesamorelin and rose 5.0% on placebo; IGF-1 rose 81.0%; glycemic measures did not differ.
Adults with HIV and abdominal fat accumulation, 86% men; tesamorelin 2 mg under the skin daily or placebo for 26 weeks.
Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, et al. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. PMID 18057338
- Randomized trial
404 people
Counts toward no label
Visceral fat fell 10.9% on tesamorelin against 0.6% on placebo at 6 months, about 18% at 12 months on continued treatment, and the improvement was rapidly lost on switching to placebo.
Adults with HIV and excess abdominal fat on antiretroviral therapy; tesamorelin 2 mg daily or placebo (2:1) for 6 months, then a 6-month re-randomized extension.
Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, et al. (2010). Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. PMID 20101189
Read further
Tesamorelin
Frequently asked questions
- Can tesamorelin be compounded?
- No. Egrifta became a licensed biologic on March 23, 2020, and FDA says products that made that transition do not qualify for the 503A or 503B compounding exemptions. Only the brand-name product may be prescribed.
- Is tesamorelin approved for weight loss?
- No. Egrifta is approved to reduce excess abdominal fat in adults with HIV-associated lipodystrophy, and its label says it is not indicated for weight loss management because its effect on weight is neutral.
- What happens when tesamorelin is stopped?
- In the 12-month trial, people switched from tesamorelin to placebo after six months rapidly lost the visceral fat reduction they had reached on the drug.