Quick answer: Tesamorelin is an FDA-approved prescription drug sold under the brand name Egrifta. Its label covers one narrow population: adults with HIV and lipodystrophy who carry excess abdominal fat. The label states it is not indicated for weight loss management. Trial results come from that population only, and the approval does not extend to other adults or to products sold as "research" tesamorelin.
| Fact | What the sources say |
|---|---|
| Class and receptor | The label calls it a growth hormone-releasing factor (GHRF) analog built on the 44-amino-acid human sequence |
| FDA status | Approved; the label lists initial U.S. approval as 2010 |
| Route as described in sources | Injected under the skin of the abdomen once daily, per the label |
| Whoosh offers this | No |
What it is
Tesamorelin is a synthetic version of the hormone that signals the pituitary gland to release growth hormone. According to its label, it consists of the 44-amino-acid human sequence with a hexenoyl group attached at one end, supplied as an acetate salt by Theratechnologies Inc. Egrifta SV and Egrifta WR are two labelled forms of the same drug. Our sermorelin profile covers the shorter peptide that acts through the same hormone family, and the sermorelin vs tesamorelin page lines the two up.
The label reports a mean elimination half-life of 8 minutes in healthy subjects after a single injection under the skin, and an absolute bioavailability below 4%. Those are label measurements for the approved product, not figures for other peptides.
The approved use, word for word
The Egrifta label reads: indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Three limitations of use sit beside it. The label says long-term cardiovascular safety has not been established; that the drug is not indicated for weight loss management because it has a weight-neutral effect; and that there are no data supporting improved compliance with anti-retroviral therapies in HIV-positive patients.
The safety and effectiveness of tesamorelin in children have not been established, according to the label, and children with open growth plates may see accelerated linear growth.
Why a narrow approval is not general approval
FDA approves a drug for a stated use in a stated population, and the evidence behind it matches that population. The Egrifta label's efficacy trials enrolled HIV-infected adults with lipodystrophy and excess abdominal fat, and excluded people with diabetes, a history of malignancy and hypopituitarism. The label does not describe use in anyone else. So "FDA-approved tesamorelin" supports exactly one claim: the labelled one. It does not support claims about adults without HIV lipodystrophy, about muscle, about sleep or about weight.
The pivotal trials
The label describes two randomized, placebo-controlled studies of 26 weeks in HIV-infected patients with lipodystrophy and excess abdominal fat. Study 1 (NCT 00123253) randomized 412 patients, 273 to tesamorelin and 137 to placebo. Study 2 (NCT 00435136) randomized 404 patients, 270 to tesamorelin and 126 to placebo.
On visceral adipose tissue, the fat deep in the abdomen, the label reports a between-group difference of -31 square centimeters in Study 1 (95% confidence interval -39 to -24) and -21 square centimeters in Study 2 (95% confidence interval -29 to -12). The label also reports changes in trunk fat and lean body mass. Those figures belong to the labelled HIV-lipodystrophy population only. They say nothing about healthy adults, and they cannot be transferred to sermorelin or to any other peptide.
Adverse reactions and contraindications as the label states them
Common adverse reactions above 5%, per the label: arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema and myalgia. The safety database covered 740 HIV-infected patients, 543 of whom received tesamorelin in the first 26 weeks.
Contraindications, per the label, include disruption of the hypothalamic-pituitary axis (for example pituitary tumor or surgery, head irradiation or trauma), active malignancy, known hypersensitivity and pregnancy. The warnings section lists increased risk of neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, injection-site reactions and increased mortality in patients with acute critical illness.
On glucose, the label reports HbA1c of 6.5% or higher in 5% of tesamorelin patients and 1% of placebo patients, and a hazard odds ratio of 3.3 (confidence interval 1.4 to 9.6). It also reports anti-tesamorelin antibodies in 50% of patients through 26 weeks.
Tesamorelin sold outside the label
On 2026-08-24 FDA issued warning letters to NuScience Peptides LLC and Royal Peptides LLC. Both name products as "research" tesamorelin or tesamorelin blends and call them unapproved new drugs. FDA states in a footnote that labels reading research use only do not change a product's intended use when a website's claims and tools, such as peptide calculators, show it is meant for people. Products named include a tesamorelin-ipamorelin blend; see the ipamorelin vs tesamorelin comparison for why evidence for one cannot stand in for the other.
Who offers it
Whoosh does not offer tesamorelin. As stated by Whoosh, read 2026-10-06, its service centers on compounded sermorelin, and compounded medications are not FDA-approved. Tesamorelin is a prescription product with its own label; a licensed physician decides whether any prescription is appropriate. Details are on the Whoosh Wellness sermorelin review.
FAQ
Is tesamorelin FDA-approved?
Yes, for the label's stated use: reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Nothing in the label extends that to other people.
Is tesamorelin a weight loss drug?
The label says it is not indicated for weight loss management, because its effect on weight is neutral.
Does tesamorelin work like sermorelin?
Both are analogs of the hormone that signals growth hormone release, according to FDA documents and the label. They differ in length, regulatory status and published evidence, as the comparison page lays out.
What are the warnings on the label?
The label lists neoplasm risk, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, injection-site reactions, and increased mortality in acute critical illness.
Sources
- EGRIFTA SV label, DailyMed read 2026-10-06
- EGRIFTA WR label, DailyMed read 2026-10-06
- FDA warning letter, NuScience Peptides LLC, 2026-08-24 read 2026-10-06
- FDA warning letter, Royal Peptides LLC, 2026-08-24 read 2026-10-06
Not medical advice. See the medical disclaimer.
