Digestive & weight GHRH analog
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
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not 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This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information.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.
If you think you are having a medical emergency, call 911.
Key takeaway
Tesamorelin (sold as Egrifta) is a synthetic analog of growth hormone-releasing hormone used to reduce excess abdominal fat in people with HIV who have lipodystrophy. It prompts the body's own pituitary to release growth hormone, which breaks down fat, and visceral fat is particularly responsive. It has been FDA-approved in the U.S. since 2010 and is given as a daily subcutaneous injection.
At a glance
- What it is
- A growth hormone-releasing hormone (GHRH) analog peptide
- Approved for
- Reduction of excess abdominal fat in HIV-associated lipodystrophy
- Key fact
- In trials it reduced visceral abdominal fat by roughly 11 to 18 percent versus little change on placebo
- Route
- Subcutaneous injection, once daily
- Evidence strength
- FDA approved
Summary
Tesamorelin (Egrifta) is an FDA-approved growth hormone-releasing hormone analog that reduces excess abdominal fat in people with HIV-associated lipodystrophy.
What is tesamorelin?
Tesamorelin, sold under the brand Egrifta, is a stabilized synthetic analog of growth hormone-releasing hormone (GHRH), the hypothalamic signal that tells the pituitary to release growth hormone. It is used specifically for the deep abdominal fat that can accumulate in people with HIV, a condition called lipodystrophy. It was developed under the code TH9507 and approved in the United States in 2010.
How does tesamorelin work?
Tesamorelin binds GHRH receptors on the pituitary and stimulates the gland to release its own growth hormone in a natural, pulsatile pattern, which in turn raises insulin-like growth factor 1. One of growth hormone's effects is lipolysis, the breakdown of fat, and visceral (intra-abdominal) fat is particularly responsive. By boosting the body's own growth hormone rather than supplying growth hormone directly, tesamorelin reduces that deep abdominal fat.
The table below shows how visceral adipose tissue changed in the HIV lipodystrophy trials.
| Group | Change in visceral adipose tissue |
|---|---|
| Tesamorelin, at 6 months | Reduced by roughly 11 percent |
| Tesamorelin, with continued treatment | Reduction approaching 18 percent |
| Placebo | Changed little |
The fat tends to return if treatment stops, because the underlying driver is unchanged.
Is it FDA-approved?
Editor’s note
Status: Yes. Tesamorelin was approved by the FDA in 2010 as Egrifta, with later formulations marketed as Egrifta SV and Egrifta WR. It is given as a daily subcutaneous injection.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Tesamorelin was approved by the FDA in 2010 as Egrifta, with later formulations marketed as Egrifta SV and Egrifta WR. It is given as a daily subcutaneous injection.
What is tesamorelin prescribed for?
Tesamorelin is prescribed to reduce excess abdominal fat in people with HIV-associated lipodystrophy. It is not approved for general weight loss, and it is contraindicated:
- In pregnancy
- In active cancer
- When the pituitary axis has been disrupted
What are the side effects?
According to the prescribing information, common side effects include:
- Injection-site reactions
- Joint, muscle, and limb pain
- Swelling from fluid retention
More serious considerations include:
- Higher blood sugar and glucose intolerance
- Fluid retention
- An increased risk of new tumors, so any existing cancer should be inactive and fully treated before starting
- Raised IGF-1 levels, which are monitored during treatment
- Allergic reactions
Sources: FDA prescribing information for Egrifta; a randomized trial of tesamorelin in HIV lipodystrophy (Falutz et al., Journal of Acquired Immune Deficiency Syndromes, 2010, DOI: 10.1097/QAI.0b013e3181cbdaff), indexed on PubMed. This document is educational and does not constitute medical advice.
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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