Source: FDA label
| Molecular formula | C221H366N72O67S |
|---|---|
| Molecular weight | 5136 g/mol |
| Registered trials | 24 |
| PubChem CID | 16137828 |
| Brand names | EGRIFTA SV |
Mechanism of Action
12.1 Mechanism of Action In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF [see Clinical Pharmacology ( 12.2 )]. Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic. GH exerts its effects by interacting with s
Key takeaways
- Tesamorelin is an FDA-approved growth hormone-releasing factor (GHRF) analog sold as EGRIFTA SV.
- It is approved specifically to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.
- The drug is weight neutral and is not approved for general weight loss.
- Long-term cardiovascular safety has not been established, per the label's limitations of use.
- The most frequently reported issues in safety databases involve dosing and administration rather than a specific adverse reaction.
What tesamorelin is
Tesamorelin is a synthetic analog of growth hormone-releasing factor (GRF), a hormone the hypothalamus normally produces. It binds to GRF receptors on pituitary cells with a potency similar to the natural hormone, prompting the pituitary to release growth hormone in its normal pulsatile pattern. Because growth hormone has both anabolic and fat-breaking (lipolytic) effects, this pathway is the basis for the drug's approved use.
What tesamorelin is approved for
Tesamorelin, marketed as EGRIFTA SV, is indicated for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. The label specifies it has a weight neutral effect and is not intended for weight loss management. It also notes that long-term cardiovascular safety has not been established, and prescribers are advised to weigh the risks and benefits of continued treatment if visceral fat does not improve. There is no evidence in the label that tesamorelin improves adherence to antiretroviral therapy. No boxed warning is present on this product.
What the evidence shows
Tesamorelin has been studied across 24 registered clinical trials. One completed Phase 1 trial examined whether a growth hormone-releasing hormone analog affects cognitive function in people with mild cognitive impairment. A separate trial looking at short-term growth hormone effects in HIV-infected patients also reached completion, while a study on abdominal obesity and cardiovascular inflammation was withdrawn before enrollment.
Reported side effects
Safety reports submitted to FAERS for tesamorelin are counts of reported events, not confirmed rates or proof of cause. The largest volume of reports centers on dosing and product handling, including dose omission issues (278), incorrect dose administered (164), and product preparation issues (121). Injection site pain (130) is the most common reaction tied directly to administration. Other reports include drug ineffective (119), weight increased (96), arthralgia (88), and incomplete therapeutic effect (86), suggesting some users report the medication not working as expected alongside joint discomfort.
FAQ
What is tesamorelin used for?
Tesamorelin, sold as EGRIFTA SV, is FDA-approved to reduce excess abdominal fat in HIV-infected adults with lipodystrophy. It is not approved for general weight loss and has a weight neutral effect overall. Prescribers are told to reassess treatment if visceral fat does not improve.
How does tesamorelin work?
Tesamorelin is a synthetic analog of growth hormone-releasing factor. It binds pituitary receptors much like the body's own hormone, triggering a natural, pulsatile release of growth hormone. This growth hormone release drives the drug's fat-reducing effect.
Does tesamorelin cause weight loss?
No. The label explicitly describes EGRIFTA SV as weight neutral, meaning it targets excess abdominal fat rather than overall body weight. It is not indicated as a weight loss treatment.
What are the most commonly reported side effects of tesamorelin?
Reports submitted to the FDA's adverse event system most often involve dosing and administration issues, such as dose omission or incorrect dose given, alongside injection site pain. These are counts of submitted reports, not confirmed rates of occurrence. Joint pain (arthralgia) and reports of the drug not working as expected also appear.
Is there a boxed warning for tesamorelin?
No. The current label for EGRIFTA SV does not carry a boxed warning. The label does note that long-term cardiovascular safety has not been established.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication.
Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.
Sources: FDA label (DailyMed) ClinicalTrials.gov FDA FAERS PubChem
Updated 2026-08-03