Hormones & metabolism GHRH analog
Compounded Tesamorelin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- On the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Tesamorelin is an FDA-approved growth-hormone-releasing peptide, sold as Egrifta, for excess abdominal fat in HIV-associated lipodystrophy. In a randomized trial of 404 people with HIV (Falutz 2010), visceral fat fell 10.9% on tesamorelin versus 0.6% on placebo over 6 months. Its off-label use for body composition and anti-aging in people without HIV is not an approved indication and lacks dedicated trials. It is banned in sport.
At a glance
- FDA status
- FDA-approved as Egrifta, but only for HIV-associated lipodystrophy
- How it works
- GHRH analog that raises the body's own growth hormone and reduces visceral fat
- Off-label use
- Wellness/body-composition use in people without HIV is not an established indication
- Sport
- Prohibited by WADA at all times
- Evidence strength
- Moderate research
Summary
Tesamorelin is FDA-approved only for HIV-associated lipodystrophy. See what is known about off-label body composition and anti-aging use in people without HIV.
What is tesamorelin?
Tesamorelin is a synthetic analog of growth-hormone-releasing hormone (GHRH). It is FDA-approved and sold as Egrifta for reducing excess visceral (abdominal) fat in people with HIV-associated lipodystrophy. In wellness settings it is used off-label for body composition and anti-aging in people without HIV; that use is the subject of this entry and is not an approved indication.
How does it work?
Tesamorelin binds pituitary GHRH receptors and stimulates the body's own growth hormone release, which raises IGF-1 and, in its approved population, reduces visceral fat. This mechanism is well established and underlies the approved use. This describes how it works, separate from whether the off-label wellness use is supported.
The label describes growth hormone released this way as both anabolic and lipolytic, meaning it also drives fat breakdown, and visceral fat is the depot the HIV trials measured. Visceral fat changed as follows in the largest trial:
| Group | Time point | Visceral fat change |
|---|---|---|
| Tesamorelin | 6-month phase | Fell 10.9% |
| Placebo | 6-month phase | Fell 0.6% |
| Tesamorelin, continued | 12 months | Fell by about 18% |
Is it FDA-approved?
Safety note
Status: FDA-approved as Egrifta, but only for HIV-associated lipodystrophy
Category: Wellness and performance · Primary body area: Hormones & metabolism
Yes, for one specific use. Tesamorelin is FDA-approved as Egrifta for excess abdominal fat in HIV-associated lipodystrophy, and it is now marketed as Egrifta SV and Egrifta WR. The label says it is not indicated for weight loss management, and it lists these contraindications:
- Pregnancy
- Active malignancy
- Disruption of the hypothalamic-pituitary axis
Any other use, including general body-composition or anti-aging use in people without HIV, is off-label and not an approved indication; compounded tesamorelin for non-approved uses falls in the unsettled peptide-compounding space. In sport, tesamorelin is banned at all times, and WADA explicitly lists it among prohibited GHRH analogs.
What does the research show?
Editor’s note
Evidence strength: Moderate research
The approved HIV-lipodystrophy use has strong randomized-trial support, but the off-label wellness and anti-aging use in people without HIV is not established by dedicated trials and reverses off treatment.
For the approved use, the evidence is strong; for the wellness use, it is extrapolated. According to PubMed, a randomized, placebo-controlled trial of 404 people with HIV-associated fat accumulation found tesamorelin significantly reduced visceral fat and raised IGF-1, with no change in glucose parameters. A 52-week extension found it generally well tolerated, and the lost visceral fat returned once treatment stopped.
However, there are no dedicated controlled trials of the off-label body-composition or anti-aging use in people without HIV; that use is an extrapolation from the HIV population, and growth hormone-axis stimulation carries class considerations such as IGF-1 elevation and effects on glucose.
Sources: a randomized trial of tesamorelin in HIV-associated abdominal fat accumulation (Falutz et al., Journal of Acquired Immune Deficiency Syndromes, 2010, DOI: 10.1097/QAI.0b013e3181cbdaff; 52-week extension, AIDS, 2008, DOI: 10.1097/QAD.0b013e32830a5058), indexed on PubMed; FDA records for Egrifta; and the WADA Prohibited List. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
approved (PDF)
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
- [14]
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