Tesamorelin: What It Is and Its U.S. Regulatory Status

What is tesamorelin?

Tesamorelin is a synthetic peptide modeled on growth hormone-releasing hormone (GHRH), the hormone the hypothalamus uses to tell the pituitary gland to release growth hormone. It is an FDA-approved prescription drug, sold in the United States under the brand name Egrifta, for one narrow use: reducing excess abdominal fat in adults with HIV who have lipodystrophy, a condition that changes where the body stores fat.

Tesamorelin is not growth hormone itself. It acts one step earlier in the hormone chain, like the older GHRH analog sermorelin.

How it works

According to the FDA label, tesamorelin contains the full 44-amino-acid sequence of human GHRH, with a short fatty chain (a hexenoyl group) attached at one end. It binds GHRH receptors on the pituitary gland, which then releases growth hormone. Growth hormone in turn raises insulin-like growth factor 1 (IGF-1). In the approval trials, the main effect measured was a reduction in visceral fat, the fat stored deep in the abdomen around the organs.

Approval history

  • 2010: the FDA first approved tesamorelin (Egrifta) for excess abdominal fat in adults with HIV and lipodystrophy.
  • March 25, 2025: the FDA approved Egrifta WR, a newer formulation that is mixed once a week instead of daily. Its maker, Theratechnologies, said it is intended to replace the earlier Egrifta SV formulation.

The current label notes that Egrifta WR and Egrifta SV differ in strength and preparation and are not substitutable for each other.

What the clinical trials measured

Approval rested on two randomized, double-blind, placebo-controlled trials in adults with HIV and excess abdominal fat, with 412 and 404 participants. The main measure was the change in visceral fat on CT scans after 26 weeks. Visceral fat fell by an average of 18% and 14% with tesamorelin, compared with a 2% rise and a 2% fall with placebo.

The label states that tesamorelin is not indicated for weight loss because it has a weight-neutral effect, and that its long-term cardiovascular safety has not been established.

Researchers have also studied it in other settings. In a 2019 trial published in The Lancet HIV, 61 adults with HIV and fatty liver disease received tesamorelin or placebo for 12 months, and liver fat fell more with tesamorelin. That use is not approved.

U.S. regulatory status

Current status: FDA-approved prescription drug (Rx only).

The approval covers Egrifta products used as labeled, with a valid prescription. It does not extend to other uses or to products sold under the tesamorelin name by other sources. Versions made by compounding pharmacies are not FDA-approved. Products labeled "for research purposes only" or "not for human consumption" are not approved medicines, and the FDA has not reviewed their contents, purity or quality.

Documented safety information

The Egrifta WR label (revised March 2025) says the drug should not be used by people with a disrupted hypothalamic-pituitary system (for example after pituitary surgery, head radiation or head trauma), people with active cancer, people allergic to tesamorelin, or during pregnancy. Its warnings include:

  • An increased risk of tumors: any earlier cancer should be inactive and its treatment complete before starting.
  • Raised IGF-1 levels, whose long-term effects are unknown.
  • Fluid retention, including swelling, joint pain and carpal tunnel syndrome.
  • Glucose intolerance or diabetes.
  • Allergic reactions and skin reactions where the drug is given.
  • Possible increased risk of death in people with acute critical illness, based on experience with growth hormone.

The most common side effects in trials included joint pain, redness and itching at the site of administration, pain in the arms or legs, swelling and muscle pain.

Sport

The World Anti-Doping Agency (WADA) 2026 Prohibited List names tesamorelin as a GHRH analog under class S2. It is prohibited at all times, in and out of competition.

Why Peptide Labs does not sell tesamorelin

Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, and we do not provide prescription medicines of any kind.

For personal medical questions, including whether tesamorelin is appropriate for you, the right person to ask is a licensed healthcare provider.

Related reading

See the full list of compound profiles in the Peptide Guide. Related profiles: sermorelin, CJC-1295 and ipamorelin. For background, read whether peptides are legal in the U.S.