Tesamorelin: Medicine Overview
Tesamorelin (Egrifta) is an FDA-approved growth-hormone-releasing-hormone analogue for excess belly fat in HIV lipodystrophy, not weight loss or anti-aging. Label facts and limits.
Content last updated . This page has not been medically reviewed.
What it is
Tesamorelin is a synthetic analogue of human growth-hormone-releasing factor (GRF, also called GHRH), a hypothalamic hormone that signals the pituitary gland to release growth hormone (GH). [1] The label describes it as the 44 amino acids of human GRF with a hexenoyl group added. [1] In laboratory tests it binds and stimulates human GRF receptors with similar potency to the body's own GRF. [1]Brand names are Egrifta SV and Egrifta WR. They are different formulations of the same active ingredient with separate labels, so a brand, a molecule and a formulation are related but not interchangeable. [2][1] See active ingredient, brand, formulation and indication.
Europe (EMA)
The European Medicines Agency page for Egrifta says the application was withdrawn. [3] The company had presented two main studies in 816 HIV patients. [3] The EMA's committee stated provisional concerns, including that the fat reduction had not been shown to be clinically meaningful in terms of actual health benefits to patients. [3] Status in the UK, Canada, Australia and elsewhere: not verified.What the trials showed
The FDA label describes two randomized, double-blind, placebo-controlled studies in HIV-infected patients with lipodystrophy and excess abdominal fat: Study 1 (412 patients) and Study 2 (404 patients). [1] The main outcome was percent change in visceral adipose tissue (fat around the organs), measured by CT scan, after 26 weeks. [1] Results at week 26, from the label: These were trials of the earlier 1 mg/vial product; the label bases the newer Egrifta WR formulation on those studies plus a comparison of how the drug is absorbed. [1]| Study 1 | Study 2 | |
|---|---|---|
| Difference vs placebo in visceral fat change (%) | -20 (95% CI -24 to -15) | -12 (95% CI -16 to -7) |
The same table shows the drug's hormone effect: IGF-1 (a growth factor that rises when GH rises) increased much more than on placebo. [1] A higher IGF-1 is a sign the drug is working as designed, not a health benefit by itself, and the label says the effects of prolonged IGF-1 elevation are unknown. [1] See biomarker changes vs meaningful health outcomes.
Label: approved medicine; established for reducing visceral fat on CT in this population. Whether that fat reduction changes heart disease, diabetes or survival is not shown by the label excerpts read. The EMA raised the same question. [3]
Professional-care context
The label asks for IGF-1 monitoring and glucose evaluation before and during therapy. [1] This page gives no preparation, injection or dosing instructions; those are for the prescriber and the product's own label.Off-label and promoted use
Marketing of tesamorelin for general anti-aging, muscle gain or weight loss is outside the label, and the label itself says it is not for weight loss. [1] Proper evidence not found in the FDA label and EMA page read for approval or demonstrated clinical benefit beyond HIV lipodystrophy. For how tesamorelin compares with other growth-hormone-releasing compounds, some of which are not approved, see growth-hormone-releasing peptides and growth hormone and IGF-1 signaling.Frequently asked questions
Is tesamorelin approved for weight loss or anti-aging?
No. The US label limits use to excess abdominal fat in HIV-infected adults with lipodystrophy and states it is not for weight loss management. [1]
Is tesamorelin the same as growth hormone?
No. It is an analogue of GRF, the signal that prompts the pituitary to release GH; it is not GH itself. [1]
Is tesamorelin approved in Europe?
The EMA application was withdrawn, so it was not authorized through the central route. [3] Other countries were not verified.
Why does the label ask for IGF-1 monitoring?
Tesamorelin increases GH and IGF-1, and the effects of long-term raised IGF-1 are unknown. [1]
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
How to read the evidence labels
Labels used on this page: approved medicine (a regulator has approved it for a named use), established, promising but limited, insufficient evidence.
Approved use (United States)
The label also states limits of use:
- It is not indicated for weight loss management because it has a weight-neutral effect. [1]
- Long-term cardiovascular safety has not been established. [1]
- There are no data showing it improves adherence to anti-HIV therapy. [1]
It is a prescription medicine for one condition, not a general anti-aging product. Laws change and this is not legal advice.
Major safety information from the label
- Contraindicated with disruption of the hypothalamic-pituitary axis (for example pituitary surgery or head irradiation), active malignancy, and pregnancy. The label says modifying visceral fat offers no benefit in pregnancy and could cause fetal harm. [1]
- Neoplasms. GH is a known growth factor, [1] and the label warns about increased risk of neoplasms, says it should not be used in active malignancy, and says any earlier cancer should be inactive with treatment complete before starting. [1]
- IGF-1. The label says to monitor IGF-1 levels and consider stopping if elevations persist. [1]
- Fluid retention (swelling, joint pain, carpal tunnel syndrome) and glucose intolerance or diabetes can develop. [1]
- Critical illness. The label lists increased mortality in patients with acute critical illness. [1]
- Children. Safety and effectiveness have not been established; in children with open growth plates it may cause excessive growth. [1]
- Common side effects (over 5%) include joint pain, injection-site redness and itching, pain in limbs, swelling and muscle pain. [1]