Tesamorelin: FDA-approved use, who qualifies and what it costs

Compounded drugs are not FDA-approved. Tesamorelin is not one of the six peptides under the interim HHS policy of 28 Oct 2026 (Federal Register 2026-22192); see our peptide legal status tracker. We found no new FDA or HHS action on it when we checked on 12 Nov 2026.

What tesamorelin is

Tesamorelin is a modified copy of growth hormone releasing hormone, the brain signal that tells the pituitary gland to release growth hormone. It is a peptide, a short chain of amino acids. It is given as an injection under the skin.

It is close to sermorelin, which acts on the same receptor. Tesamorelin was built to last longer in the body. For a side-by-side look, read sermorelin vs tesamorelin.

What the label says it is for

The Egrifta WR label states it "is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy" (read 12 Nov 2026). It sets a clear limit too: "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect."

So the approved group is narrow. Adults without HIV lipodystrophy are outside the label. A prescriber can still choose to use a drug off-label, but the trial evidence we cite does not cover that case.

Who qualifies

For the approved use, you need an HIV diagnosis and lipodystrophy with extra belly fat. Your HIV clinician decides if that fits. The label says it should not be used in some situations, including pituitary tumors or other pituitary problems, active cancer and pregnancy.

Warnings on the label include tumor growth, raised IGF-1 (a hormone that rises when growth hormone rises), fluid retention and higher blood sugar. The label also says long-term heart safety has not been established. Read it in full with your prescriber.

What the trials show

The label describes two randomized studies, in "412 HIV-infected patients with lipodystrophy and excess abdominal fat" and "404 HIV-infected patients with lipodystrophy and excess abdominal fat." Deep belly fat fell over 26 weeks. It came back for some people who were switched to a dummy shot (placebo).

We found no comparable trial for general weight loss or muscle gain in adults without HIV. Claims of that kind rest on weaker evidence. Our tesamorelin vs ipamorelin guide covers how it compares with another growth hormone peptide.

What it costs

The approved brand, made by Theratechnologies, prints no price on its product site. What you pay depends on your insurance and your prescriber, so ask both.

Programs that print a price for compounded tesamorelin start at $195 a month at FoundationRx (3-month plan). Every program we track is on the tesamorelin price page. A compounded version is made by a 503A pharmacy (see FDA's compounding page), a state-licensed pharmacy that prepares a drug for one patient. It is not the approved product. For the wider picture, see what peptides cost.

How to get it from a licensed program

Licensed programs work like this: you fill in a health form, a clinician reviews it, and if they prescribe it, a US pharmacy ships it. Look for plain facts on the page: what the monthly price includes, whether there is a membership fee and how billing repeats. Our best peptide programs ranking shows how each program scores.

We compare licensed prescription programs only. Research-labeled vials are not prescribed by a clinician, and we do not cover those sellers.

Your prescriber sets the form and amount; we do not publish doses.

FAQ

What does tesamorelin do?

Tesamorelin signals the pituitary gland to release growth hormone. Its approved use is reducing extra belly fat in adults with HIV lipodystrophy. In the two label trials, deep belly fat fell over 26 weeks. The label says it is not for weight loss management.

Is tesamorelin FDA-approved?

Yes, for one use: reducing excess abdominal fat in HIV-infected adults with lipodystrophy, sold as Egrifta. Compounded versions from pharmacies are not the approved product and are not FDA-approved. Check our legal status tracker for dated changes.

How much is tesamorelin without insurance?

The approved brand prints no price. Licensed programs that compound it print monthly prices from $195, listed on our tesamorelin price page with billing terms. The right number for you depends on the program, the supply length and any first-order offer.

Can you get tesamorelin online?

Yes, through licensed telehealth programs where a clinician reviews your history and a US pharmacy fills the order. Some print a monthly price. Sellers with no prescriber step are research-labeled vendors, which we do not cover.

Is tesamorelin the same as Egrifta?

Egrifta is the FDA-approved brand of tesamorelin. Compounded tesamorelin from a 503A pharmacy contains the same peptide name but is a separate product, made for one patient and not reviewed by FDA for safety or effectiveness.

Is tesamorelin the same as sermorelin?

No. Both act on the growth hormone releasing hormone receptor, but they are different molecules. Tesamorelin has an approved brand for one use. Sermorelin has no approved product today and can be compounded on a prescription.

Bottom line

Tesamorelin is an approved drug for a narrow group, and compounded versions are a separate, lower-evidence route. To price your options, use the cost page or see the best peptide programs.