Tesamorelin is one of the few growth hormone releasing peptides with a current FDA approval. That approval is for a specific group of patients, which shapes how the evidence should be read.
Key points
- Tesamorelin is FDA-approved, sold as Egrifta WR.
- Its indication is reducing excess abdominal fat in adults with HIV and lipodystrophy.
- The label says it is not indicated for weight loss management.
- Trials show less visceral and liver fat in people with HIV; evidence outside HIV is limited.
- Compounded tesamorelin is not equivalent to Egrifta WR.
Where things stand (as of November 2026)
Tesamorelin is FDA-approved, sold as Egrifta WR (approved March 2025; first approved as Egrifta in 2010). The label indication is "the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy."
The label also says it is not indicated for weight loss management, and long-term cardiovascular safety has not been established. Any other use is off-label.
Federal law limits pharmacies from compounding copies of a commercially available approved drug, so compounded tesamorelin is not equivalent to Egrifta WR.
How it works
Tesamorelin is a stabilized analog of growth hormone releasing hormone (GHRH). It prompts the pituitary to release growth hormone, which raises IGF-1 and reduces visceral, or deep abdominal, fat.
What the evidence shows
In a 2007 New England Journal of Medicine randomized trial in people with HIV and excess abdominal fat, tesamorelin reduced visceral fat compared with placebo over 26 weeks.
A 2019 Lancet HIV randomized trial found it reduced liver fat in people with HIV and fatty liver disease. Evidence outside HIV is limited.
Safety
Per the label, joint pain, injection site reactions, swelling and higher blood sugar can occur. It is not for use in pregnancy or in people with active cancer or pituitary disorders. Glucose and IGF-1 are monitored.
Common questions
Is tesamorelin FDA-approved?
Yes. Tesamorelin is FDA-approved and sold as Egrifta WR, approved in March 2025. It was first approved as Egrifta in 2010.
What is tesamorelin approved for?
The reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Any other use is off-label.
Is tesamorelin a weight loss drug?
No. The label says it is not indicated for weight loss management. It targets visceral fat in a specific group of patients.
How is tesamorelin different from sermorelin?
Both prompt the pituitary to release growth hormone. Tesamorelin is a stabilized analog with a current FDA approval for one use. Sermorelin was approved as Geref and is no longer sold as an approved product.
Can Institute of Function prescribe tesamorelin?
A physician decides whether it fits your situation and its label. We review options at your visit, and prescribing is never guaranteed.
What this means for patients
- Tesamorelin is an approved medicine for a narrow, specific use.
- Use outside that label is off-label and starts with a physician assessment.
What this does not mean
- It does not mean tesamorelin is a weight loss drug.
- A compounded product is not equivalent to Egrifta WR.
Sources
- EGRIFTA WR prescribing information, revised 3/2025
FDA label with the approved indication, limitations of use, warnings and monitoring.
- Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357:2359-2370.
Randomized trial showing reduced visceral fat with tesamorelin versus placebo over 26 weeks.
- Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. 2019.
Randomized trial showing reduced liver fat in people with HIV and fatty liver disease.
Many peptide-based therapies remain investigational for musculoskeletal pain, recovery, and performance applications. Available evidence varies by compound, indication, and route of administration. Treatment decisions require physician evaluation, informed consent, and compliance with applicable law.
Want to understand whether this applies to you?
Request a Private AssessmentHave imaging, labs, or prior treatment records?
Request a Private Assessment