Tesamorelin Prices

How it works

What has been studied in humans

The core of the human evidence is the HIV lipodystrophy program, which randomized 806 patients across two phase 3 trials ^[8]. Around it sit a 61-person dose-ranging study, a 50-person single-center imaging study, a 61-person multicenter liver-fat trial, and smaller trials in obesity, type 2 diabetes and cognitive aging ^[4][9][10]. The population matters: HIV-associated lipodystrophy is a specific fat-redistribution syndrome, and results in that group do not automatically transfer to adults without HIV ^[18].

The 2005 dose-ranging trial randomized 61 adults with increased waist circumference and waist-to-hip ratio to placebo or one of two active doses for 12 weeks ^[4]. The regimen reported in the cited human trial was 2 mg subcutaneously once daily at the top dose. IGF-1 rose 48 percent at 1 mg and 65 percent at 2 mg, trunk fat fell 9.2 percent at 2 mg versus 0.8 percent with placebo, and the ratio of visceral to subcutaneous fat improved significantly at both doses. Visceral fat fell 15.7 percent at 2 mg, a change that did not reach significance against placebo in this small study. Triglycerides and the cholesterol to HDL ratio improved at 2 mg, and glucose did not change ^[4].

Study 1 randomized 412 adults, 86 percent men, to 2 mg daily or placebo for 26 weeks ^[5]. The regimen reported in the cited human trial was 2 mg subcutaneously once daily. Visceral fat fell 15.2 percent versus a 5.0 percent rise, triglycerides fell 50 mg/dL versus a 9 mg/dL rise, the total cholesterol to HDL ratio fell 0.31 versus a 0.21 rise, and IGF-1 rose 81 percent versus a 5 percent fall. Glycemic measures did not differ significantly, and more patients on tesamorelin withdrew because of an adverse event ^[5].

Study 2 randomized 404 adults in a 2 to 1 ratio for 6 months, then re-randomized those on tesamorelin to continue or switch to placebo ^[7]. The regimen reported in the cited human trial was 2 mg subcutaneously once daily. Visceral fat fell 10.9 percent versus 0.6 percent at 6 months, trunk fat, waist circumference and waist-to-hip ratio improved, and limb and abdominal subcutaneous fat did not change. Patient ratings of belly appearance distress and physician ratings of belly profile improved, and about 18 percent visceral reduction was maintained at 12 months in the continued group. The benefit was rapidly lost after switching to placebo ^[7].

The 2008 extension reported 52-week safety for 273 tesamorelin and 137 placebo recipients from Study 1, with re-randomization at week 26 ^[6]. Visceral fat stayed 18 percent below baseline, triglycerides stayed 51 mg/dL below baseline, and glucose parameters did not change in a clinically significant way. Visceral fat reaccumulated after tesamorelin stopped. The pooled analysis of both trials reported 806 patients and confirmed the 15.4 percent treatment effect on visceral fat at week 26, a non-significant 0.6 percent change in subcutaneous fat, and a maintained visceral reduction at week 52 ^[8].

Liver fat became another major program. In a 50-person single-center trial at Massachusetts General Hospital, 2 mg daily for 6 months reduced visceral fat by 34 square centimeters versus an 8 square centimeter rise, a treatment effect of minus 42 square centimeters. Liver fat, measured as the percentage of lipid relative to water, fell 2.0 percent versus a 0.9 percent rise, a net effect of minus 2.9 percentage points. Fasting glucose rose at 2 weeks, and the difference was no longer significant at 6 months ^[9].

The larger liver trial enrolled 61 adults with HIV and a hepatic fat fraction of at least 5 percent by proton magnetic resonance spectroscopy, a scan that estimates fat content without a biopsy ^[10]. The regimen reported in the cited human trial was 2 mg once daily for 12 months. Hepatic fat fraction fell 4.1 percentage points absolute, a 37 percent relative reduction, and 35 percent of treated participants versus 4 percent of placebo participants fell below 5 percent. Fasting glucose and HbA1c did not differ at 12 months, and injection site complaints were more common with tesamorelin ^[10].

Cognition was tested in 152 adults aged 55 to 87, including 66 with mild cognitive impairment, or MCI, a stage between normal aging and dementia ^[11]. The regimen reported in the cited human trial was 1 mg subcutaneously once daily before bedtime for 20 weeks. Global cognition improved in the intention-to-treat analysis, meaning everyone assigned to a group was analyzed whether or not they finished, with p=0.03 (the p value is the chance of seeing a difference this large if the treatment did nothing, so smaller means stronger). A completer analysis was stronger, executive function improved with p=0.005, and verbal memory showed a trend with p=0.08. IGF-1 rose 117 percent, body fat fell 7.4 percent, fasting insulin rose 35 percent in the MCI group, and adverse events were reported by 68 percent of treated versus 36 percent of placebo participants ^[11].

Two later studies did not replicate that result. A 22-person double-blind pilot gave 1 mg daily for 10 weeks and found no significant change in cognition, body composition, fatigue, sleep, physical performance or glucose tolerance; a machine-learning analysis of brain imaging suggested differences in two brain regions ^[12]. A 73-person open-label phase 2 trial compared 2 mg daily with standard care for 6 months in virologically suppressed adults with HIV and abdominal obesity. The tesamorelin group showed a within-group cognitive trend with p=0.060, and the between-group difference was not significant with p=0.673. Waist circumference fell by a median 2.7 centimeters more than standard care, and IGF-1 rose without correlating with cognitive change ^[13].

Outside HIV, a 60-person trial enrolled abdominally obese adults with reduced GH secretion for 12 months ^[14]. Visceral fat fell 16 square centimeters versus a 19 square centimeter rise, a treatment effect of minus 35 square centimeters. Carotid intima-media thickness, an ultrasound measure of artery wall thickness, fell 0.04 millimeters, C-reactive protein fell, and triglycerides fell 37 mg/dL more than placebo, while subcutaneous fat and glucose measures did not change. In 53 adults with type 2 diabetes, 12 weeks of 1 mg or 2 mg daily did not alter the insulin response, fasting glucose, HbA1c or diabetes medication changes, and total and non-HDL cholesterol fell modestly at 2 mg ^[15].

The 2026 meta-analyses pool the randomized trials. One included four trials and 909 patients and found a visceral fat difference of minus 21.47 square centimeters, with substantial heterogeneity, plus a 1.42 kilogram gain in lean body mass and a 1.61 centimeter fall in waist circumference ^[16]. Another pooled five trials and found minus 27.71 square centimeters for visceral fat and minus 4.28 percentage points for hepatic fat, with no significant change in subcutaneous fat or BMI ^[17]. Their trial sets overlap, so they are not independent confirmations ^[16][17].

The label defines the limits of this evidence. Long-term cardiovascular safety has not been established, there is no information in patients over 65 years, and pediatric safety and effectiveness have not been established ^[18]. The randomized placebo-controlled trials in this record lasted up to 12 months, and none was powered for heart attacks, strokes or death ^[10][18].

Doses studied in human trials

As of October 2026, tesamorelin remains FDA-approved only for HIV-associated abdominal fat accumulation and unapproved for every other use. Regimens below are those reported in the cited human trials.

Lab and animal studies

The preclinical package is compact and was built to support a daily injectable. TH9507 was designed to resist dipeptidyl peptidase IV, slowed degradation in rat, dog and human plasma, and raised GH and IGF-1 in pigs, rats and dogs at daily doses up to 600 micrograms per kilogram ^[2]. Toxicokinetics, the measurement of drug exposure in toxicity studies, showed dose-related exposure by both intravenous and subcutaneous routes, and the apparent elimination half-life in dogs ranged from 21 to 45 minutes ^[2].

Four-month rat and dog toxicity studies formed the safety base. Both species tolerated repeated dosing, with a significant but not dose-related increase in body weight gain and a stronger anabolic response at higher exposure. Dogs showed more evident and reversible liver and kidney findings, anemia, clinical chemistry changes and organ weight effects, which the authors attributed to prolonged exposure to supraphysiological GH and IGF-1 ^[2]. Those findings are the animal counterpart of the IGF-1 elevation seen in patients ^[18].

An inhaled formulation was tested in beagle dogs. Intratracheal dry powder at about 375 micrograms per kilogram produced 41 percent bioavailability relative to a 38 microgram per kilogram subcutaneous dose, and 13 percent absolute bioavailability. The terminal half-life was 39 minutes after intratracheal dosing and 26 minutes after subcutaneous dosing, and mean residence time was longer after inhalation, 74 minutes versus 52 minutes ^[3]. The work showed that the lung could absorb the peptide but did not produce an approved inhaled product.

Reproductive and genetic toxicology are summarized in the label. Tesamorelin given to rats during organogenesis, the period when fetal organs form, caused hydrocephaly in offspring at about two times the clinical exposure by AUC, and lower doses caused delayed skull ossification. AUC is the total drug exposure over time. Rabbits showed no adverse developmental effects at doses up to about 500 times the clinical exposure. Lifetime carcinogenicity studies in rodents were not conducted, and Ames and chromosomal tests were negative ^[18].

The limits of this literature are specific. The two animal papers report pharmacokinetic, pharmacodynamic and toxicity endpoints, and neither reports an animal model of HIV-associated lipodystrophy or of selective visceral fat loss ^[2][3]. Claims that tesamorelin selectively mobilizes visceral fat therefore rest on the human imaging trials, and on the pooled computed tomography data in particular ^[8][18].

Research in detail

History and where it stands today

Theratechnologies developed tesamorelin from a 61-person dose-ranging study through a narrow FDA approval, a withdrawn European application, and an imaging evidence base that still defines the field.

1. 2005A 12-week randomized, double-blind, placebo-controlled dose-ranging trial in 61 adults with HIV and central fat accumulation tested two active doses against placebo ^[4]. IGF-1 rose 48 percent and 65 percent at the two doses, trunk fat fell 9.2 percent versus 0.8 percent with placebo, and visceral fat fell 15.7 percent at the top dose without reaching significance against placebo ^[4].
2. 2007Study 1 randomized 412 adults with HIV and excess abdominal fat, 86 percent of them men, to tesamorelin or placebo for 26 weeks ^[5]. Visceral fat on computed tomography fell 15.2 percent versus a 5.0 percent rise, triglycerides fell 50 mg/dL versus a 9 mg/dL rise, and IGF-1 rose 81 percent ^[5].
3. 2010Study 2 randomized 404 adults and reported visceral fat down 10.9 percent versus 0.6 percent at 6 months, with no change in limb or subcutaneous fat ^[7]. The pooled analysis of both phase 3 trials covered 806 patients and confirmed a 15.4 percent treatment effect on visceral fat at week 26 ^[8].
4. November 2010After FDA's advisory committee voted 16 to 0 in May 2010 that tesamorelin should be approved at the studied dose, FDA approved EGRIFTA on November 10, 2010 under application 022505, even as a division director's review called the clinical benefit of the visceral fat reduction uncertain ^[20][26].
5. June 2012Ferrer Internacional withdrew its application for a centrally authorized Egrifta in Europe on June 21, 2012, after the Committee for Medicinal Products for Human Use reached a provisional opinion that the product could not be approved ^[23][24]. The committee cited fat reduction that was not shown to be clinically meaningful, rising IGF-1 as a major safety concern, and the absence of long-term safety data ^[24].
6. 2014A 50-person single-center trial at Massachusetts General Hospital found a net reduction of 2.9 percentage points in liver fat at 6 months, measured as the percentage of lipid relative to water ^[9].
7. 2019The 61-person multicenter liver trial reported a 4.1 percentage point absolute fall in hepatic fat fraction at 12 months, a 37 percent relative reduction, and 35 percent of treated participants versus 4 percent of placebo participants fell below 5 percent ^[10].
8. March 2020FDA deemed the EGRIFTA application a biologics license application on March 23, 2020, and the product line later included EGRIFTA SV and EGRIFTA WR ^[18][19][20].
9. June 2026On the Huberman Lab peptides episode published June 1, 2026, Dr. Abud Bakri described adults combining a GLP-1S medicine, testosterone therapy and a growth hormone option such as tesamorelin or ipamorelin in what he called a 'trinity stack' ^[27].
10. October 2026As of October 2026, tesamorelin is approved only for reduction of excess abdominal fat in adults with HIV and lipodystrophy, and it is not on the 503A bulk drug substances list ^[18][20][25]. The 2026 WADA Prohibited List names it among GHRH analogs in section S2.2.4, and the NCAA banned list covers it through the class rule on peptide hormones and growth factors ^[21][22].

How it compares with related peptides

Side effects and safety signals

Human safety data come from the phase 3 program and its extensions, and the main systemic concerns are glucose and IGF-1.

• The controlled dataset covers 543 tesamorelin and 263 placebo recipients in the 26-week combined phase 3 data. Injection site reactions occurred in 17 percent versus 6 percent, peripheral edema, meaning swelling from fluid retention, in 6 percent versus 2 percent, and paresthesia, meaning tingling or numbness, in 5 percent versus 2 percent ^[18]. Hypersensitivity reactions occurred in 4 percent of treated patients, the label advises stopping the drug if one is suspected, and the label has no boxed warning ^[18].
• Incident diabetes, defined as HbA1c at least 6.5 percent, occurred in 5 percent of tesamorelin recipients and 1 percent of placebo recipients, with a hazard ratio of 3.3 and a 95 percent confidence interval of 1.4 to 9.6 ^[18]. A hazard ratio compares the rate of an event over time between groups. Mean fasting glucose and HbA1c did not differ significantly in the phase 3 trials, so the signal sits in incident diabetes while the averages stayed flat ^[8][18].
• Among patients treated for 26 weeks, 47 percent had IGF-1 above 2 SDS and 36 percent above 3 SDS, where SDS means standard deviation score, a measure of how far a value sits from the age-matched normal average, and the label advises considering discontinuation for persistent elevations above 3 SDS ^[18].
• The European committee called rising IGF-1 a major safety concern in 2012 because high levels may be associated with increased cancer risk and with worsening of diabetic eye disease ^[24].
• Contraindications are disruption of the hypothalamic-pituitary axis, active malignancy, hypersensitivity and pregnancy, and the label warns of increased mortality in patients with acute critical illness, a class warning shared with growth hormone products ^[18].
• At approval FDA concluded that a risk evaluation and mitigation strategy was not warranted because its review identified no safety concerns beyond those already known for growth hormone products, and it required postmarketing work including a long-term observational study ^[26].
• There are no cardiovascular outcome data, no lifetime carcinogenicity data and no safety data in pregnancy, and the effects of prolonged IGF-1 elevation on cancer risk and diabetic retinopathy remain uncharacterized in controlled trials, with the longest randomized follow-up in this record at 12 months ^[10][18].
• The 2026 meta-analysis flagged higher discontinuation rates with tesamorelin, with a risk ratio of 2.25, although the confidence interval crossed 1, so the difference was not statistically firm ^[16].
• Tesamorelin is not on the 503A bulk drug substances list at 21 CFR 216.23(a), the federal list of bulk ingredients that compounders may use under section 503A of the Food, Drug, and Cosmetic Act, and the approved EGRIFTA products are the FDA-reviewed form ^[20][25]. Purity and identity testing on research-grade certificates is tracked in the COA library.

The future: what's next for Tesamorelin

Two phase 2 trials of tesamorelin are recruiting as of October 2026. NCT06554717, at Massachusetts General Hospital, is a quadruple-blind, placebo-controlled trial in an estimated 100 adults with HIV that tests tesamorelin as an add-on to home exercise, with change in repeated chair-stand time as the primary outcome and an estimated primary completion in June 2028 ^[28]. NCT03150511, at Johns Hopkins, is testing tesamorelin against no treatment for recovery of hand function after surgical repair of upper-extremity nerve injury in an estimated 36 patients, with an estimated completion in December 2027 ^[29].

The completed trials define the current evidence base. They are registered as NCT00123253 (Study 1) ^[5], NCT01263717 (the 50-person liver-fat study), NCT02196831 (the 61-person multicenter liver trial) ^[9][10], NCT00257712 (cognition), NCT01264497 (type 2 diabetes) and NCT02553603 (the 22-person cognition pilot) ^[11][12][15]. The 2026 meta-analyses call for longer treatment durations, dose-response studies and patient-reported outcomes, and they note the limited long-term safety data ^[16][17].

On the regulatory side, FDA's 2010 approval required a long-term observational study, and the European application was withdrawn in 2012 with no European refiling recorded ^[23][24][26]. As of October 2026, the approved indication remains HIV-associated abdominal fat accumulation ^[18][20]. Expansion into weight loss, fatty liver disease or cognitive aging would need a program with cardiovascular, histological or cognitive endpoints.

• Whether a 15 percent visceral fat reduction translates into fewer cardiovascular events or better survival is unresolved, because no trial in this record was powered for heart attacks, strokes or death ^[18].
• Long-term safety beyond 52 weeks remains open, with incident diabetes, new cancers, diabetic retinopathy and sustained IGF-1 elevation as the specific concerns that need controlled follow-up ^[18][24].
• Whether the cognitive signal from 2012 can be replicated is unclear, because a 22-person pilot and a 73-person open-label trial did not confirm it and the dose, duration and population that might benefit remain undefined ^[11][12][13].
• Whether liver fat reduction improves steatohepatitis or fibrosis on histology is not known, because the 61-person trial measured fat by spectroscopy and left histological outcomes for a larger biopsy-based study ^[10].
• Whether visceral fat responds while subcutaneous fat does not remains unexplained at the tissue level, even though the imaging trials show the pattern clearly ^[8][18].