Growth hormone axis
Tesamorelin
Tesamorelin is FDA-approved as Egrifta, with a prescription, for one use: extra belly fat in adults with HIV. The evidence grade is moderate-human for that use. It is not approved for weight loss, muscle or healing. Tesamorelin sold online for research is not legal.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Egrifta, Egrifta WR, Egrifta SV | primary | dailymed.nlm.nih.gov | |
| Class | growth-hormone-axis | primary | dailymed.nlm.nih.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-24 | primary | accessdata.fda.gov | |
| Evidence grade | moderate-human | our assessment | peptideindex.ai | |
| Label dosing | From the Egrifta WR label and the Egrifta SV label. Both are shots under the skin of the belly once a day. Egrifta WR is 1.28 mg a day. The Egrifta SV label gives 1.4 mg a day. The two forms are not swapped for one another. The prescriber sets the dose. | primary | dailymed.nlm.nih.gov |
Short answer
Tesamorelin is FDA-approved as Egrifta, with a prescription, for one use: extra belly fat in adults with HIV. The evidence grade is moderate-human for that use. It is not approved for weight loss, muscle or healing. Tesamorelin sold online for research is not legal.
Our assessment, drawn from the sources below.
What it is
Tesamorelin is a prescription drug. It is a lab-made copy of a natural hormone that tells the body to release growth hormone [2]. Growth hormone then raises IGF-1, a growth signal in the blood [2]. FDA first approved it in November 2010, under the brand name Egrifta [1].
It is a daily shot under the skin of the belly [2] [3]. It is approved for adults with HIV who have lipodystrophy. That is a shift in body fat that some HIV medicines can cause, with extra fat deep in the belly [2] [17]. The label says it is not for weight loss, because it does not change body weight [2].
Today it comes in two forms, Egrifta WR and Egrifta SV [2] [3]. FDA approved the WR form in March 2025 [4] [19].
Where it stands legally
Tesamorelin is FDA-approved: FDA approved it as Egrifta in November 2010 to reduce extra belly fat in adults with HIV who have lipodystrophy [1] [2]. That covers Egrifta WR and Egrifta SV, with a prescription, for that one use. It does not cover weight loss, and it does not make tesamorelin sold for research legal [2] [7]. Checked 24 October 2026.
There is a gap between the approved use and what sellers offer it for. The label names one use, belly fat in adults with HIV [2]. In July 2026, FDA reviewed five seller websites [7] [8] [9] [10] [23]. They described it for body shape, fat loss, muscle, tissue repair, memory and liver health [7] [8] [9] [10] [23]. FDA called every one of those products an unapproved new drug [7] [8] [9] [10] [23].
Since March 2020, the law has treated tesamorelin as a biologic, a type of protein drug [1] [5]. FDA says the federal compounding rules do not cover biologics [6]. So pharmacies may not make their own copies of it [6] [11]. Tesamorelin is not on FDA's Category 1 or Category 2 lists of raw ingredients for compounding [21] [22].
What the evidence shows
Evidence grade: moderate-human · our assessment
The evidence grade is moderate-human: several trials in people agree that it shrinks deep belly fat in adults with HIV [13] [14] [17] [18]. All of the trials were in adults with HIV. Most lasted 6 to 12 months.
In a 26-week trial of 412 adults with HIV and extra belly fat, deep belly fat fell by 15.2% on it. On a dummy shot, it rose by 5.0% [13]. Blood fats also improved [13]. In a second trial of 404 adults with HIV, deep belly fat fell by 10.9% on it over 6 months. On a dummy shot, it fell by 0.6% [14]. People who kept taking it for a year kept about 18% less deep belly fat. Those who switched to a dummy shot lost the gain quickly [14].
Two smaller trials in adults with HIV found it also lowered liver fat. One had 50 people and one had 61 [15] [16]. A 2026 review of four trials with 909 people found less deep belly fat and a smaller waist [17]. It also found more people stopped taking it, though that result was not certain [17]. A second 2026 review of five trials found similar results [18].
The trials tested the approved drug in adults with HIV. They tell us nothing about tesamorelin sold for research, which FDA has not approved [7].
Known risks
- It can raise blood sugar and the chance of diabetes. After 26 weeks in trials, 5% on it had a high long-term sugar reading. On a dummy shot, 1% did [2].
- It raises IGF-1, a growth signal in the blood. The label says not to use it with an active cancer, and to stop if a cancer comes back [2].
- It can make the body hold fluid. That can cause swelling, joint pain and a pinched nerve in the wrist [2].
- In trials, 4% had an allergic reaction such as itching or a rash. A quarter had redness, itching or pain where the shot went in. On a dummy shot, 14% did [2].
- The label says not to use it in pregnancy [2]. In the first large trial, more people on it than on a dummy shot quit because of unwanted effects [13].
- Tesamorelin sold for research is not made under FDA rules. FDA warns that injected products skip some of the body's defenses against germs and toxins [7].
What nobody knows yet
- Nobody knows how it affects the heart over many years. The label says long-term heart safety has not been shown [2].
- Nobody knows what years of high IGF-1 levels do to the body. The label says the effects are unknown [2].
- Nobody knows how long people need to take it. In one trial, the belly fat came back quickly after people stopped [14].
- It lowered liver fat in two small trials. Nobody knows yet if that prevents liver disease later on [15] [16].
- No trial cited here tested it in people without HIV, or for healing or memory, uses some sellers claim [9] [13]. A 2026 review found lean body mass rose in people with HIV who took it. Nobody knows if that happens in people without HIV [17].
Legitimate ways to get it
The legal way to get tesamorelin is a prescription for Egrifta WR or Egrifta SV [1] [2] [3]. The label is for adults with HIV who have extra belly fat from lipodystrophy [2].
The two forms are not swapped for one another. They use different doses and are mixed in different ways [2]. The maker said Egrifta WR will replace Egrifta SV [19] [20].
Because the law treats it as a biologic, pharmacies may not make their own copies [5] [6] [11].
Approved product
Approved by FDA and sold with a prescription as a daily shot under the skin of the belly. It comes in two forms, Egrifta WR and Egrifta SV, which are not swapped for one another.
Brand names: Egrifta WR, Egrifta SV
Manufacturer: Theratechnologies Inc.
Indication: To reduce extra belly fat in adults with HIV who have lipodystrophy. Not for weight loss.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07481734
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Phase: Phase 2 · Sponsor: Hudson Biotech · Status: Recruiting
Countries: China
US states: none listed
NCT06554717
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Phase: Phase 2 · Sponsor: Massachusetts General Hospital · Status: Recruiting
Countries: United States
US states: Colorado, Massachusetts
NCT03150511
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Phase: Phase 2 · Sponsor: Johns Hopkins University · Status: Recruiting
Countries: United States
US states: Maryland
How people are getting it anyway
This section describes what happens and is not a recommendation.
Outside a prescription, tesamorelin reaches people through online sellers that label it for research use [7] [12]. On 24 August 2026, FDA sent warning letters to five such sellers [7] [8] [9] [10] [23]. Each letter names tesamorelin [7] [8] [9] [10] [23]. Two sellers also offered a mix of tesamorelin and another peptide [7] [9].
The sellers' labels said the products were for research only, or not for people [7] [8] [9] [10] [23]. FDA said their websites showed the products were meant for people anyway [7] [8] [9] [10] [23]. It called them unapproved new drugs, and sending them across state lines breaks federal law [7]. FDA warns that injected products skip some of the body's defenses against germs and toxins [7]. It is unclear where and how these products are made [11].
No FDA page we found names tesamorelin at a clinic, an online prescriber, or as a fake or imported product. So this page does not describe those channels.
Research use seller
Sold online labeled for research use or not for people, sometimes mixed with another peptide.
The lawFDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says.fda.gov
Documented riskFDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness.fda.gov
Documented riskFDA says no approved application covers these products, so their safety and benefit for the sellers' uses have not been shown.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including tesamorelin and a tesamorelin blend.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including tesamorelin.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including tesamorelin and a tesamorelin blend.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including tesamorelin.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including tesamorelin.fda.gov
Sources
- [1]Drugs@FDA: Egrifta, biologic license application 022505Regulatory · primary
- [2]DailyMed: Egrifta WR prescribing information, revised March 2025Label · primary
- [3]DailyMed: Egrifta SV prescribing information, revised 2024Label · primary
- [4]FDA approval letter for Egrifta WR, supplement 020, 25 March 2025Regulatory · primary
- [5]FDA: approved applications for biological products deemed to be licenses on 23 March 2020Regulatory · primary
- [6]FDA guidance: mixing, diluting, or repackaging biological products outside the approved license, January 2018Regulatory · primary
- [7]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
- [8]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
- [9]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
- [10]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
- [11]Alliance for Pharmacy Compounding: compounding peptides, a briefing for prescribers, August 2022Legal analysis · legal-analysis
- [12]Sheppard Mullin: FDA warning letters to unlawful peptide sellers, 2026Legal analysis · legal-analysis
- [13]Tesamorelin for belly fat in adults with HIV, first large trial, 2007Rct · peer-reviewed
- [14]Tesamorelin in adults with HIV and belly fat, with a safety extension, 2010Rct · peer-reviewed
- [15]Tesamorelin and belly and liver fat in adults with HIV, 2014Rct · peer-reviewed
- [16]Tesamorelin and fatty liver disease in adults with HIV, 2019Rct · peer-reviewed
- [17]Review and meta-analysis: tesamorelin in people with HIV and lipodystrophy, 2026Systematic review · peer-reviewed
- [18]Meta-analysis: tesamorelin and body fat, liver fat and safety in HIV lipodystrophy, 2026Systematic review · peer-reviewed
- [19]The Pharma Letter: new Egrifta form approved, 26 March 2025Reference · established-news
- [20]Contract Pharma: FDA approves Egrifta WR, 26 March 2025Reference · established-news
- [21]FDA: 503A bulk drug substances under evaluation, Category 1 and Category 2 listsRegulatory · primary
- [22]FDA: bulk drug substances that may present significant safety risks, Category 2Regulatory · primary
- [23]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
Last verified · 6 facts · 8 sources
- clinicaltrials.gov
- dailymed.nlm.nih.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- accessdata.fda.gov
- accessdata.fda.gov
- fda.gov
Primary source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
Status alerts
Get status alerts for Tesamorelin
No alert has been sent yet. Until alerts begin, the confirmation is the only email you will get.