Tesamorelin: approved uses, evidence and safety
Egrifta treats a specific HIV-related fat-distribution condition. Other uses and unapproved formulations need separate evidence and regulatory scrutiny.
The short answer
Tesamorelin is a synthetic growth-hormone-releasing-factor analog approved in Egrifta formulations to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. The labels do not indicate it for weight-loss management. It is regulated as a biologic and is ineligible for ordinary 503A/503B compounding exemptions; authorized investigation is separate.
Definition
Tesamorelin (tesamorelin acetate, TH9507; brands Egrifta SV and Egrifta WR) is a synthetic growth-hormone-releasing factor analog approved to reduce excess abdominal fat in adults with HIV-associated lipodystrophy.
Key takeaways
- Tesamorelin is a synthetic growth-hormone-releasing factor analog, sold as Egrifta SV and Egrifta WR.
- FDA approved it in November 2010 for one use: reducing excess abdominal fat in adults with HIV and lipodystrophy. Both labels say it is not for weight-loss management.
- In the main 26-week trial of 412 adults with HIV, visceral fat fell 15.2% versus a 5.0% placebo increase. The pooled subcutaneous-fat difference was not statistically significant, which does not prove no effect.
- FDA regulates tesamorelin as a biologic. The ordinary 503A/503B compounding exemptions do not apply; authorized clinical investigation is a separate framework.
- Selected liver, cognition and DXA body-composition findings do not establish a general weight-loss, strength or longevity indication.
Key facts
| Fact | Detail |
|---|---|
| Other names | Tesamorelin acetate, TH9507; brands Egrifta SV, Egrifta WR |
| Class | Growth-hormone-releasing factor (GHRF) analog[1] |
| Initial approval | November 10, 2010, application 022505[12] |
| Approved use | Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy[1] |
| Label limits | Long-term heart safety not established; not for weight-loss management; no data on better HIV-drug adherence[1] |
| Forms the labels list | Egrifta SV, 2 mg single-dose vial; Egrifta WR, 11.6 mg single-patient-use vial[1][2] |
| Regulated as | A biologic since March 23, 2020[4] |
| Compounding | Not eligible for the 503A or 503B exemptions[5] |
| Sport | WADA Prohibited List 2026, S2.2.4[10] |
Tesamorelin is the active ingredient in Egrifta, with an FDA-approved indication for excess abdominal fat in adults with HIV-associated lipodystrophy [1] [2]. That approval does not establish general weight loss, aging benefits or equivalence of an unapproved product. FDA’s biologic framework also makes the ordinary 503A/503B compounding exemptions inapplicable [5].
Tesamorelin is the active drug in Egrifta
Tesamorelin is a synthetic analog of growth-hormone-releasing factor, the brain's signal that tells the pituitary to release growth hormone [6]. It doesn't contain growth hormone. In the main trial, IGF-1, a blood marker of growth-hormone activity, rose 81% on tesamorelin against a 5% fall on placebo [6].
Current DailyMed records identify Theratechnologies as the labeler/manufacturer of the two Egrifta formulations [1] [2]. The September 2026 FDA Purple Book lists original 1 mg Egrifta as discontinued and SV/WR as licensed prescription products [12]. Formulation identity matters because the products are not substitutable.
What Egrifta is approved for, and what the label rules out
Both Egrifta labels approve tesamorelin for one thing: "the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy" [1] [2]. Lipodystrophy here means a shift in body fat, often to the belly, seen in some people with HIV.
The labels then list what the approval does not cover. In their own words:
Long-term cardiovascular safety of EGRIFTA SV has not been established. … EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.[1]
The WR label carries the same indication limitations [2]. A reduction in a specific abdominal-fat compartment is different from established weight-loss management. The label’s weight-neutral wording should be read alongside the selected off-label body-composition findings, rather than as proof that no tissue measure ever changes.
The labels also build in a stopping point. They tell prescribers to weigh the risks and benefits of continuing treatment in patients whose visceral fat has not gone down [1]. A drug with that instruction is meant to be judged on a measured result, not taken open-ended in hope of one.
Visceral-fat findings do not establish general weight loss
In the 26-week phase 3 trial of 412 adults with HIV and excess belly fat, 86% of them men, visceral fat fell 15.2% on tesamorelin and rose 5.0% on placebo [6]. Triglycerides fell 50 mg/dL against a 9 mg/dL rise. The trial found no significant differences in blood-sugar measures.
A pooled analysis of two phase 3 trials, 806 adults in all, confirmed the visceral-fat effect: a treatment effect of about 15% at 26 weeks. The subcutaneous-fat comparison was a 0.6% difference that was not statistically significant; this is not proof of a zero effect [7]. In people who stayed on the drug to 52 weeks, visceral fat was 17.5% below where it started.
The pooled trials randomized 543 people to tesamorelin and 263 to placebo. Visceral-fat area fell about 3.7 square inches (24 cm²) on active treatment and rose about 0.3 square inches (2 cm²) on placebo [7]. This is a scan measurement in a selected population, not a predicted weight change or proof that every other body compartment is unaffected.
Selected off-label studies include liver, cognition and body composition
The examples below are selected off-label trials, not an exhaustive catalog. Study population, formulation and outcome definition matter; a positive research endpoint does not create a general clinical indication.
Liver evidence is not limited to one trial. An earlier 2014 randomized study enrolled 50 adults with HIV and abdominal fat accumulation;48 received treatment. After6 months, hepatic lipid-to-water percentage changed by a median −2.0% with tesamorelin versus +0.9% with placebo, a net −2.9 percentage-point difference (P=.003) [11]. This preliminary outcome is not interchangeable with the 2019 hepatic-fat-fraction metric.
Stanley’s 2019 trial enrolled 61 adults with HIV and fatty liver, with 60 receiving treatment. At 12 months, hepatic-fat fraction changed 4.1 percentage points more favorably than placebo (95% CI −7.6 to −0.7), a 37% relative reduction;35% versus 4% reached HFF below 5% [8]. The selected HIV population and MRI endpoint do not establish a general liver-treatment indication.
In 152 older adults, 66 of them with mild cognitive impairment, 20 weeks of tesamorelin modestly improved a combined thinking score (p = 0.03) and executive function [9]. Body fat fell 7.4% and DXA lean mass rose 3.7%, without a body-weight difference; lean mass is not a strength test. Fasting insulin rose 35% in the group with cognitive impairment, which is the kind of result that tempers enthusiasm. This too is off-label and exploratory.
| Study | Population | Design and size | Effect | Strength of evidence |
|---|---|---|---|---|
| Falutz 2007 [6] | Adults with HIV and excess belly fat | Randomized, placebo-controlled, 412 people, 26 weeks | Visceral fat -15.2% vs +5.0%; triglycerides -50 vs +9 mg/dL | High (approved use) |
| Falutz 2010 [7] | Adults with HIV on antiretrovirals | Pooled analysis of 2 phase 3 trials, 806 people | Visceral fat effect about -15%; fat under the skin -0.6% (not significant) | High (approved use) |
| Stanley 2019 [8] | 61 adults with HIV and fatty liver | Randomized, placebo-controlled, 12 months | Liver-fat fraction -4.1 points vs placebo (37% relative) | Selected HIV population; off-label |
| Baker 2012 [9] | 152 adults aged 55 to 87 | Randomized, placebo-controlled, 20 weeks | Cognition P=.03; DXA lean+3.7%, fat−7.4%; no body-weight difference | Low to moderate; off-label, one trial |
| Stanley 2014 [11] | 50 randomized HIV-positive adults;48 treated | Placebo-controlled,6 months | Hepatic lipid/water median−2.0% versus +0.9%; net −2.9 percentage points;P=.003 | Preliminary selected-population result; different liver metric from 2019 |
Side effects and who should not use it, from the label
Because tesamorelin is approved, it has an FDA-reviewed safety section. The most common side effects, in more than 5% of patients, were joint pain, redness and itching at the injection site, pain in the arms or legs, swelling in the legs, and muscle pain [1].
- Injection-site reactions: 25% on Egrifta against 14% on placebo in the first 26 weeks [1].
- Blood sugar: HbA1c reached 6.5% or higher in 5% of Egrifta patients against 1% on placebo by week 26 [1].
- IGF-1: the drug raises IGF-1, and the label says the effects of prolonged elevation are unknown; it tells prescribers to monitor IGF-1 [1].
- Fluid retention: swelling, joint pain and carpal tunnel syndrome can occur [1].
- Other label warnings: hypersensitivity and neoplasm concerns; the acute-critical-illness warning draws on deaths reported with pharmacologic growth hormone, not an established tesamorelin trial-death rate [1].
The label lists four groups who must not use it: people with a disrupted hypothalamic-pituitary axis, people with active cancer, people allergic to tesamorelin or its ingredients, and anyone who is pregnant [1] [2]. The full safety picture, including what happens with compounded versions, is in is tesamorelin safe.
Why "compounded tesamorelin" has no pathway
On March 23, 2020, a group of protein drugs approved as ordinary drug applications were transferred to biologic licenses. Egrifta and Egrifta SV are on FDA's list of those transitioned products [4]. FDA's notice to compounders that day was direct: these biological products "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B" [5].
The ordinary 503A and 503B exemptions do not supply a bulk-compounding pathway for tesamorelin [5]. This does not imply that appropriately authorized investigation is forbidden; that framework has separate manufacturing, nonclinical, protocol and oversight requirements [13].
This is also why the site lists no tesamorelin programs or prices. For the approval question by itself, see is tesamorelin FDA approved.
| Version | FDA-approved? | Who makes it | Lawful path | What it means for you |
|---|---|---|---|---|
| Egrifta SV | Yes, for HIV-associated belly fat | Theratechnologies | Prescription, dispensed as the brand | The labeled product; off-label use is the prescriber's call |
| Egrifta WR | Yes, same use (approved 2025) | Theratechnologies | Prescription, dispensed as the brand | Not interchangeable with SV |
| "Compounded tesamorelin" | No | Not established by a compounded-product label | None under 503A or 503B since March 23, 2020 [5] | Ask the seller who made it and under what authority |
| Research-use label | No | Identity and manufacturer require verification | Label alone does not establish human-treatment authorization | Confirm applicable authorization, oversight and product identity |
Tesamorelin's FDA timeline, 2010 to 2025
| Date | Event | Source |
|---|---|---|
| November 10, 2010 | FDA approves Egrifta (tesamorelin), application 022505, a new molecular entity. | Drugs@FDA [12] |
| March 23, 2020 | Egrifta and Egrifta SV are deemed biologic licenses (BLAs). | FDA transition list [4] |
| March 23, 2020 | FDA tells compounders that transitioned biologics are not eligible for the 503A or 503B exemptions. | FDA notice [5] |
| March 25, 2025 | FDA approves Egrifta WR, a new formulation with a multiple-dose presentation. | FDA approval letter [3] |
Egrifta SV vs Egrifta WR: two formulations that are not interchangeable
FDA approved the newer Egrifta WR formulation on March 25, 2025, with a multiple-dose presentation [3]. Both labels say the two formulations differ in dosage, the number of vials needed, preparation and storage, and state plainly: "EGRIFTA WR and EGRIFTA SV are not substitutable" [2].
| Feature | Egrifta SV | Egrifta WR |
|---|---|---|
| Vial | 2 mg, single-dose [1] | 11.6 mg, single-patient-use [2] |
| Approved use | Excess abdominal fat in adults with HIV and lipodystrophy | Same |
| Label limits | Not for weight-loss management; long-term heart safety not established | Same |
| Interchangeable? | No | No |
Dosing and preparation differ between the two and are set out in each label. Follow the prescriber and the label for the product you're given.
Tesamorelin vs sermorelin and other growth-hormone peptides
| Peptide | FDA status | Relevant distinction |
|---|---|---|
| Tesamorelin | Approved as Egrifta for HIV-associated belly fat only | Ordinary503A/503B exemptions do not apply |
| Sermorelin | Approval withdrawn in 2009, not for safety | Historical approval does not approve current compounded products |
| Ipamorelin | Never approved | Current records do not establish ordinary retail bulk eligibility; authorized research is separate |
| CJC-1295 | Never approved | Current records do not establish ordinary retail bulk eligibility; advisory vote alone is not a legal exemption |
Tesamorelin and sermorelin both act on the same pituitary signal, but they are different molecules with different records. Our tesamorelin vs sermorelin page compares them on evidence, and does tesamorelin work looks at what the trials mean outside HIV.
Why so many people search for compounded tesamorelin
An approved-drug reputation can obscure the limits of the indication. The roughly 15% visceral-fat result comes from adults with HIV-associated fat accumulation [6]. Baker’s trial nevertheless measured DXA body composition in older adults without HIV; therefore, “no non-HIV body-composition evidence” is too absolute [9]. That small exploratory finding did not show body-weight loss or establish routine obesity, muscle-function or longevity treatment.
Confirm the approved formulation and reason for treatment
Egrifta SV and WR are approved prescription products with a specific labeled indication. Off-label prescribing of an approved product is different from approval of that use, supply of an unapproved preparation or an authorized clinical investigation. The prescriber must assess the formulation, evidence, contraindications and monitoring relevant to the patient.
The evidence does not establish routine general weight-loss or longevity treatment. Selected liver, cognition and DXA results should not be erased, but neither should they be promoted as a proven broad benefit. The efficacy review separates those findings, and how we check explains the evidence approach.
Terms used on this page
- GHRH analog: a lab-made molecule that mimics growth-hormone-releasing hormone, the signal for the pituitary to release growth hormone.
- Visceral adipose tissue (VAT): fat deep in the abdomen around the organs, as opposed to fat just under the skin.
- Deemed BLA (biologic transition): the March 2020 move of certain protein drugs from drug applications to biologic licenses, which ended their compounding eligibility.
- Lipodystrophy: abnormal distribution of body fat, here the belly-fat buildup seen in some people with HIV.
- IGF-1: insulin-like growth factor 1, a blood marker that rises with growth-hormone activity.
Research on Tesamorelin
Off-label prescribing and unapproved peptides: two different questions
An approved medicine used for another condition and an unapproved product have different evidence and regulatory questions.
Who was actually studied? Matching peptide evidence to the reader
Age, diagnosis, formulation and trial duration determine how directly a study can answer a personal treatment question.
What adverse-event reports tell us about peptide safety
A report count can identify a concern without proving causation or measuring how often an event occurs among everyone treated.
Does tesamorelin need to be refrigerated? What the current labels say
The two current tesamorelin products are room-temperature drugs. The refrigerator advice you'll still see online belongs to the original 2010 vial.
Does tesamorelin work? Evidence by outcome
Tesamorelin is one of the few growth-hormone peptides with large randomized trials behind it. They answer a narrower question than the one most buyers are asking.
How long does tesamorelin stay in your system?
Half-life figures for tesamorelin online run from 26 minutes to 3 hours. The FDA labels say something different, and the effect you care about lasts far longer than the drug.
How to take tesamorelin: what the two Egrifta labels say
FDA-approved Egrifta products have formulation-specific instructions. Here is what they cover in plain words, what they leave to your prescriber, and why an unapproved "tesamorelin peptide" vial lacks FDA-approved instructions.
Is tesamorelin FDA-approved? Yes, as Egrifta, for one use
The approval is real, but it covers one brand and one condition. Here is what FDA's own records say about every version you might be offered.
Is tesamorelin safe? What the Egrifta label and trials show
The brand has a full FDA label with trial rates. Unapproved versions lack an FDA-approved prescribing label. Here is what each one tells you, side by side.
Tesamorelin compared
CJC-1295 vs tesamorelin: two GHRH copies, one approved drug
Both were developed as longer-acting versions of the same brain hormone, and both were tested in people with HIV. One became Egrifta. The other's patient trial was stopped and never published.
Tesamorelin vs ipamorelin: an approved brand and a peptide that never was
One has two phase 3 trials and an FDA label. The other has one failed phase 2 trial and a unanimous vote against it. Neither has a pharmacy route, and that changes what "better" can mean.
Tesamorelin vs sermorelin: two GHRH drugs with very different records
Both peptides tell the pituitary to release growth hormone, and online they are often pitched as rival anti-aging options. Their regulatory status, their trials and the way patients get them have almost nothing in common.
Frequently asked
- Is tesamorelin a steroid?
- No. It is a peptide that stimulates growth-hormone release, not an anabolic steroid. Egrifta is a prescription product; product approval and anti-doping status are separate questions.
- Is tesamorelin the same as HGH?
- No. Tesamorelin contains no growth hormone. It prompts the pituitary to release the body's own, which is why IGF-1 rose in the trials.
- Can women take tesamorelin?
- The approved use covers adults with HIV and lipodystrophy, not only men, though 86% of people in the main trial were men. The label rules it out in pregnancy.
- Is tesamorelin banned in sports?
- Yes. WADA's 2026 Prohibited List names tesamorelin under S2.2.4, growth-hormone-releasing factors, which are prohibited at all times.
- Does tesamorelin cause weight loss?
- The labels do not indicate Egrifta for weight-loss management and describe a weight-neutral effect. Selected studies report visceral-fat or DXA tissue changes; a nonsignificant subcutaneous-fat comparison does not prove zero effect.
- Can tesamorelin be compounded?
- FDA’s biologic framework makes it ineligible for ordinary 503A/503B compounding exemptions. Properly authorized investigation has a separate framework; a prescription or research label alone does not supply that authorization.
Sources
- [1] DailyMed: Egrifta SV, prescribing information revised February 2024; patient instructions March 2024. DailyMed label
- [2] DailyMed. EGRIFTA WR (tesamorelin) for injection, prescribing information (label revised 03/2025) (2025). DailyMed label
- [3] FDA: supplemental BLA 022505/S-020 approval letter for Egrifta WR,2025. FDA
- [4] FDA. List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020. FDA
- [5] FDA. Notice to compounders: changes that affect compounding on March 23, 2020. FDA
- [6] Falutz J. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med (2007). PMID 18057338
- [7] Falutz J. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two phase 3 trials with safety extension data. J Clin Endocrinol Metab (2010). PMID 20554713
- [8] Stanley TL. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV (2019). PMID 31611038
- [9] Baker LD. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol (2012). PMID 22869065
- [10] World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026), section S2.2.4 (2026). Source
- [11] Stanley TL. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA (2014). PMID 25038357
- [12] FDA Purple Book: September 2026 product data (2026). FDA
- [13] FDA: Investigational New Drug framework (accessed 2026). FDA