What is tesamorelin, and what does the research show?

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy, not for anti-aging or longevity (checked October 14, 2026). We do not sell or prescribe tesamorelin. Providers listed on this site decide what they offer, and a licensed clinician decides whether any treatment is appropriate.

What tesamorelin is

Tesamorelin has the 44 amino acid sequence of human growth hormone-releasing factor, with a six-carbon group added at one end.[1] According to the Egrifta WR prescribing information, tesamorelin prompts the pituitary gland to release the body's own growth hormone, which in turn raises blood levels of IGF-1, a growth factor.[1]

Sources: Egrifta WR injection prescribing information, Revised 3/2025.

Tesamorelin is a different drug from sermorelin, CJC-1295, ipamorelin and recombinant growth hormone, and results for those drugs are not results for tesamorelin.

The World Anti-Doping Agency's 2026 Prohibited List, in effect from January 1, 2026, names tesamorelin as an example of a growth hormone-releasing hormone analogue.[2]

Visceral fat in adults with HIV

The Egrifta WR prescribing information describes two randomized, double-blind, placebo-controlled studies in adults with HIV, lipodystrophy and excess abdominal fat, which randomized 412 and 404 people and lasted 26 weeks each.[1] The main measurement was the change in visceral fat on a CT scan.[1] The drug's maker sponsored both studies.[3]

At 26 weeks, visceral fat area on CT was on average 31 square centimeters smaller with tesamorelin than with placebo in the first study (95% confidence interval 24 to 39) and 21 square centimeters smaller in the second (95% confidence interval 12 to 29).[1] The label's figures carry forward the last measurement of people who left early, and 80% of people in the first study and 74% in the second completed the 26 weeks.[1] Visceral fat on a scan is a measurement and not a health outcome such as a heart attack.

A 2026 meta-analysis whose authors reported no funding and no conflicts of interest pooled four randomized trials in 909 people with HIV, and the two studies in the Egrifta WR prescribing information make up 806 of those 909 people (88.7%).[4] The 2026 meta-analysis found visceral fat area about 21 square centimeters lower with tesamorelin than with placebo (95% confidence interval 8 to 35) and rated its certainty in that result as moderate.[4] One of the four trials in the 2026 meta-analysis enrolled people with HIV and fatty liver, and its authors rated two of the four, including the first of the two studies in the Egrifta WR prescribing information, at high risk of bias.[4] Visceral fat on a scan is a measurement and not a health outcome such as a heart attack.

In the two studies in the Egrifta WR prescribing information, waist circumference was on average 2 centimeters smaller with tesamorelin than with placebo in the first study (95% confidence interval 0.9 to 2.8) and 1 centimeter smaller in the second (95% confidence interval 0.3 to 2.5).[1] The 2026 meta-analysis found waist circumference 1.61 centimeters smaller with tesamorelin than with placebo (95% confidence interval 0.95 to 2.28), in a review whose pool of 909 people is 88.7% (806) from the two studies in the Egrifta WR prescribing information.[4] In the two studies in the Egrifta WR prescribing information, trunk fat fell by an average of 1.0 and 0.8 kilograms with tesamorelin and rose by 0.4 and 0.2 kilograms with placebo, and lean body mass rose by 1.3 and 1.2 kilograms with tesamorelin and fell by 0.2 and 0.03 kilograms with placebo.[1] Trunk fat and lean body mass are body composition measurements and not measures of strength or physical function. The Egrifta WR prescribing information says the two studies used a different formulation of the drug, and that Egrifta WR was shown to reach the blood to a comparable degree.[1]

In both studies, people who had taken tesamorelin for 26 weeks were assigned again, at random, to continue it or to switch to placebo for another 26 weeks.[1] In the first study, visceral fat area rose by an average of 25 square centimeters in the 50 people switched to placebo and by 3 in the 154 who continued tesamorelin.[1] In the second study, visceral fat area rose by an average of 24 square centimeters in the 85 people switched to placebo and fell by 11 in the 92 who continued.[1] FDA's 2010 review concluded that 'for patients discontinuing tesamorelin, there was no durability of effect'.[5] FDA's 2010 review noted that the extension enrolled only patients who had shown efficacy or tolerability in the first 26 weeks, which it called 'an enriched population for both safety and effectiveness'.[5]

FDA's 2010 Division Director review said tesamorelin 'clearly met its primary efficacy endpoint in two pivotal studies', but that the reductions in visceral fat 'were not accompanied by robust or consistent changes' in how patients rated their body image or in blood fat measures.[5] FDA's 2010 Division Director review also said that 'data are absent' on the long-term clinical benefits of the drug for cardiovascular risk and for adherence to HIV medicines, and on the long-term risks of elevated IGF-1 levels.[5]

In the published abstract of the second study, patient ratings of distress about belly appearance were described as significantly improved (P = 0.02).[6] FDA's 2010 review reported that belly appearance distress scores improved in both treatment groups, with no significant difference between them in the first study (P = 0.076) and a significant difference in the second (P = 0.022), and it called the results overall 'not robust'.[5] In the first study's published report, triglycerides fell by 50 milligrams per deciliter with tesamorelin and rose by 9 with placebo.[7] FDA's 2010 review said that significant reductions in triglycerides and cholesterol ratios 'were observed in one study but not the other', and that 'at best' it could conclude only that 'there were no adverse changes in lipid profiles'.[5]

Sources: Egrifta WR injection prescribing information, Revised 3/2025.

Weight

In the two studies in the Egrifta WR prescribing information, the average difference in body weight from placebo was 0.4 kilograms lower in the first study (95% confidence interval 1.3 lower to 0.5 higher) and 0.2 kilograms higher in the second (95% confidence interval 0.7 lower to 1.3 higher).[1] Weight was not the main outcome of either study.[1]

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are FDA-approved for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, not for weight loss. The Egrifta WR label says: 'EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.' Using tesamorelin for weight loss is off-label.

Sources: Egrifta WR injection prescribing information, Revised 3/2025.

Body fat in people without HIV

In a 2012 randomized, double-blind, placebo-controlled trial of 60 abdominally obese adults who had been selected for low growth hormone secretion, visceral fat area on CT was 35 square centimeters lower with tesamorelin than with placebo after 12 months (95% confidence interval 12 to 58).[8]

The 2012 trial in abdominally obese adults also reported carotid artery wall thickness 0.04 millimeters lower with tesamorelin (95% confidence interval 0.01 to 0.07), and no significant effect on abdominal subcutaneous fat or on glucose measures.[8] We read the abstract and the funding and disclosure statements, but not the rest, of the 2012 trial in abdominally obese adults, and the abstract does not mention HIV.[8] The 2012 trial in abdominally obese adults was supported by National Institutes of Health grants and partly funded by the drug's maker, which also supplied the drug, and one of its authors reported being a consultant to the maker and receiving investigator-initiated research funds from it.[8]

In searches of PubMed and ClinicalTrials.gov on October 8, 2026, we found no trial of tesamorelin in adults with normal growth hormone secretion, without HIV or another selected disease, whose main outcome was fat loss, muscle gain, sleep or lifespan.

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy, not in people without HIV (checked October 14, 2026).

Liver fat

In a 2019 randomized, double-blind trial funded by the US National Institutes of Health, 61 adults with HIV and fatty liver received tesamorelin or placebo for 12 months.[9] Among the 54 people analyzed for the main result, the share of the liver made up of fat fell by 4.1 percentage points more with tesamorelin than with placebo (95% confidence interval 0.7 to 7.6).[9]

In the 2019 liver fat trial, 35% of people in the tesamorelin group had their liver fat fraction fall below 5%, against 4% in the placebo group.[9] In the 2019 liver fat trial, an overall biopsy score of liver fat, inflammation and cell damage did not change significantly (effect size -0.3, 95% confidence interval -1.0 to 0.5).[9] The authors of the 2019 liver fat trial wrote that tesamorelin 'did not improve existing fibrosis in this cohort', and the trial found no effect on LDL cholesterol, HDL cholesterol or triglycerides.[9]

The drug's maker supplied the drug at reduced cost for the 2019 trial, and one of its authors, who has consulted for the maker, is named on a patent application on tesamorelin and liver disease.[9]

In a 2014 randomized, placebo-controlled trial of 50 adults with HIV and abdominal fat at one hospital, median liver fat changed by -2.0% with tesamorelin and by 0.9% with placebo after 6 months (P = .003).[10] The 2014 trial of 50 adults with HIV also reported visceral fat area 42 square centimeters lower with tesamorelin than with placebo (95% confidence interval 14 to 71).[10] The 2014 trial was funded by the National Institutes of Health, and the drug's maker supplied the drug and reviewed the manuscript before it was submitted.[10]

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are FDA-approved for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, not for reducing liver fat. Using tesamorelin to reduce liver fat is off-label. FDA has not reviewed whether it is safe and effective for that purpose.

Thinking and memory

A 2012 trial in older adults reported better scores on thinking and memory tests with a lower dose of tesamorelin than the label's studies used, and its authors wrote that the clinical significance of the findings 'remains unclear'. A 2025 open-label trial in people with HIV found no significant difference from standard care.[11][12]

In a 2012 randomized, placebo-controlled trial, 152 adults aged 55 to 87, some with mild cognitive impairment, took a lower dose of tesamorelin than the label's studies used, or placebo, for 20 weeks.[11] The authors reported a favorable effect across the three test composites (P = .03), with a result for executive function (P = .005), a trend for verbal memory (P = .08) and no reliable effect on visual memory.[11] The authors of the 2012 trial in older adults wrote that the changes on individual tests were small, about 0.25 standard deviations, and that, without information on daily functioning, the clinical significance of the findings 'remains unclear'.[11] The 2012 trial in older adults was funded by the National Institutes of Health and the Department of Veterans Affairs, and the drug's maker supplied the tesamorelin and placebo at no cost.[11]

The abstract of the 2012 trial in older adults also reports that treatment 'reduced percent body fat by 7.4%' (P < .001), a secondary result.[11] The authors of the 2012 trial in older adults report that treatment 'did not affect mood (P = .31) or sleep quality (P = .98)' in adults with mild cognitive impairment or in healthy older adults, and sleep quality was a secondary measure.[11]

In a 2025 open-label trial of 73 people with HIV and cognitive impairment, randomized 3 to 2 to tesamorelin or standard care for 6 months, the difference between the groups in cognitive performance was not significant (P = .673).[12] The authors of the 2025 open-label trial described its limits as 'insufficient power and no placebo arm'.[12] In a 10-week double-blind, placebo-controlled pilot of 22 adults with cognition ranging from normal to mildly impaired, the authors wrote that low-dose treatment 'was not directly linked with significant changes in study measures'.[13]

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are prescription injections approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy, not for weight loss (checked October 14, 2026).

Aging and long-term outcomes

In searches of PubMed and ClinicalTrials.gov on October 8, 2026, we found no trial of tesamorelin that measured heart attacks, strokes, fractures or deaths as its outcome.

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are FDA-approved for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, not for anti-aging or longevity. Using tesamorelin for anti-aging or longevity is off-label. FDA has not reviewed whether it is safe and effective for that purpose.

Evidence table

Evidence levels in this table follow our grading key. Emerging means some controlled human evidence that falls short of consistent randomized trials, such as small or short trials, mixed results, scan measurements instead of health outcomes, or trials funded by a maker.

Evidence against means controlled human trials tested the claim on its main outcome and did not find the effect, and no controlled trial found it. Not graded means we give no level, either because the studies did not test the claim as a main outcome or because the searches found no study. No support found means the searches named in that row found no study that supports the claim.

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are prescription injections approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy, not for weight loss (checked October 14, 2026).

Is tesamorelin FDA-approved?

Egrifta SV and Egrifta WR, the tesamorelin products whose labels we reviewed, are prescription injections approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy, not for weight loss (checked October 14, 2026).

FDA status table for tesamorelin products.

The Egrifta SV prescribing information lists three limitations of use. First: 'Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.' Second: 'EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect.' Third: 'There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.'

The Egrifta WR prescribing information lists three limitations of use. First: 'Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.' Second: 'EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.' Third: 'There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.'

Sources: Egrifta SV injection prescribing information, Revised 02/2024; Egrifta WR injection prescribing information, Revised 3/2025.

Each tesamorelin product in the FDA status table is available only with a prescription (checked October 14, 2026).

Whether a product is appropriate for a specific person is decided by a licensed clinician using that product's prescribing information.

Regulatory status checked October 14, 2026. Sources: www.accessdata.fda.gov/…/022505s018lbl.pdf; www.accessdata.fda.gov/…/022505s020lbl.pdf; purplebooksearch.fda.gov/…/index.cfm; www.accessdata.fda.gov/…/index.cfm; www.fda.gov/…/download

What are the risks of tesamorelin?

The Egrifta WR prescribing information names four groups of most commonly reported adverse reactions: hypersensitivity reactions, edema-related reactions, hyperglycemia and injection site reactions.[1] The Egrifta WR prescribing information describes fluid retention as increased tissue turgor and musculoskeletal discomfort 'resulting in adverse reactions (e.g. edema, arthralgia, and carpal tunnel syndrome) which are either transient or resolve with discontinuation of treatment'.[1]

In the two studies in the Egrifta WR prescribing information, IGF-1 was on average 122 nanograms per milliliter higher with tesamorelin than with placebo in the first study (95% confidence interval 101 to 141) and 105 higher in the second (95% confidence interval 85 to 126).[1] In the Egrifta WR prescribing information, 47% of patients treated for 26 weeks had IGF-1 levels greater than 2 standard deviation scores, and 36% had scores greater than 3.[1] The Egrifta WR prescribing information states that the 'effects of prolonged elevations in IGF-1 levels are unknown'.[1]

The Egrifta WR prescribing information says the drug 'induces the release of endogenous growth hormone (GH), a known growth factor', and it says to 'Carefully consider the decision to start treatment' given the increased background risk of malignancies in people with HIV.[1] FDA's 2010 review described its concern as 'long-term exposure to the growth potential of IGF-1, particularly on cancer risk', which it said 'could not be addressed feasibly by the applicant in its clinical trials'.[5]

In the Egrifta WR prescribing information, 5% of people taking tesamorelin and 1% of those taking placebo had an HbA1c of 6.5% or higher by week 26.[1] The published abstracts of the two studies in the Egrifta WR prescribing information say that glycemic measures did not differ significantly in the first and that no change in glucose parameters was observed in the second.[6][7] The Egrifta WR prescribing information lists type 2 diabetes and previous treatment with insulin or oral diabetes medicines among its exclusion criteria, yet its description of the participants reports diet-controlled diabetes in 5.6% to 6.7% of those in the first study and 9% to 10% of those in the second.[1]

In a 2014 trial of 50 adults with HIV and abdominal fat, fasting glucose was 7 milligrams per deciliter higher with tesamorelin than with placebo at 2 weeks (95% confidence interval 1 to 14), and 2 higher at 6 months (95% confidence interval 6 lower to 10 higher).[10]

The Egrifta WR prescribing information reports that hypersensitivity reactions occurred in 4% of patients treated in clinical trials.[1] The Egrifta WR prescribing information also reports anti-tesamorelin antibodies in 50% of patients treated for 26 weeks and 47% of those treated for 52 weeks, and in 85% of the patients who had hypersensitivity reactions.[1]

FDA's 2010 review counted 27 hypersensitivity reactions among tesamorelin-treated patients and 1 among placebo patients.[5]

The Egrifta WR prescribing information reports injection site reactions in 25% of treated patients and 14% of placebo patients during the first 26 weeks of clinical trials.[1] In the adverse reaction table of the Egrifta WR prescribing information, with 543 people on tesamorelin and 263 on placebo, peripheral edema was reported by 6% and 2%, myalgia by 6% and 2%, paresthesia by 5% and 2%, and arthralgia by 13% and 11%.[1]

The Egrifta WR prescribing information notes that adverse reaction rates seen in clinical trials 'may not reflect the rates observed in practice'.

The Egrifta WR prescribing information says that increased mortality in patients with acute critical illness 'has been reported after treatment with pharmacologic amounts of growth hormone', and it notes that the drug stimulates growth hormone production.[1]

FDA's 2010 review reported serious adverse events in 3.7% of people on tesamorelin and 4.2% on placebo, and stopping because of an adverse event in 9.6% and 6.1%.[5] A 2026 meta-analysis whose pool includes the two label studies found that people on tesamorelin were more likely to stop because of an adverse event (risk ratio 2.25, 95% confidence interval 0.98 to 5.17), a range that includes no difference.[4] A 2026 meta-analysis whose authors reported no funding and no conflicts of interest pooled four randomized trials in 909 people with HIV, and the two studies in the Egrifta WR prescribing information make up 806 of those 909 people (88.7%).[4]

The Egrifta WR prescribing information says that the safety and effectiveness of Egrifta WR in pediatric patients have not been established, and that there is no information on its use in patients older than 65.[1]

In a 2012 trial in adults aged 55 to 87 at a lower dose than the label's studies used, 68% of those given tesamorelin and 36% of those given placebo reported an adverse event.[11] In the 2012 trial in adults aged 55 to 87, the dose was changed because of adverse events in 13 of 78 people given tesamorelin and 2 of 74 given placebo, and fasting insulin rose by 35% in adults with mild cognitive impairment (P < .001), within the normal range.[11]

FDA's 2010 review summarized that in rats and dogs dosed for 6 months and 52 weeks, some animals developed glucose intolerance or severe diabetes, higher cholesterol, increased organ weight and acromegalic features.[5] The Egrifta WR prescribing information says that lifetime carcinogenicity studies in rodents have not been conducted with tesamorelin acetate.[1]

The Egrifta SV prescribing information has no boxed warning. It lists four groups in whom Egrifta SV is contraindicated: 'Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.' 'Patients with active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy'. 'Patients with known hypersensitivity to tesamorelin or the excipients in EGRIFTA SV'. 'Pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm'. Its warnings and precautions cover increased risk of neoplasms, elevated IGF-1 levels, fluid retention, glucose intolerance or diabetes mellitus, hypersensitivity reactions, injection site reactions, and increased mortality in patients with acute critical illness.

The Egrifta WR prescribing information has no boxed warning. It lists four groups in whom Egrifta WR is contraindicated: 'Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.' 'Patients with active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy'. 'Patients with known hypersensitivity to tesamorelin or the excipients in EGRIFTA WR'. 'Pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm'. Its warnings and precautions cover increased risk of neoplasms, elevated IGF-1 levels, fluid retention, glucose intolerance or diabetes mellitus, hypersensitivity reactions, injection site reactions, and increased mortality in patients with acute critical illness.

Sources: Egrifta SV injection prescribing information, Revised 02/2024; Egrifta WR injection prescribing information, Revised 3/2025.

Do not change or stop a prescribed medicine without talking with the clinician who prescribed it.

If you are thinking about using tesamorelin, talk to a licensed clinician first.

If you have severe symptoms, call 911 or seek emergency care. Report side effects to FDA MedWatch.

Related pages

• Sermorelin Therapy: Evidence, Risks and FDA Status
• What Does FDA-Approved Mean?
• Off-Label Prescribing Explained: What Off-Label Means
• How We Grade Medical Evidence