Tesamorelin

The only growth hormone secretagogue with a marketing authorisation, approved for a narrow indication in people with HIV, and increasingly prescribed and sold for everything except that.

Summary

• Tesamorelin is a synthetic analogue of the full 44-amino-acid growth-hormone-releasing hormone with a trans-3-hexenoic acid group on the N-terminus that protects it from enzymatic breakdown. It stimulates the pituitary to release growth hormone in a pulsatile pattern.1

• FDA-approved since November 2010 as Egrifta, for one indication: reduction of excess abdominal fat in adults with HIV who have lipodystrophy. The label states it is not indicated for weight loss and has a weight-neutral effect.2

• In two Phase 3 trials pooling 806 patients, 26 weeks of 2 mg daily reduced visceral fat by 15.4 percent relative to placebo, with no change in subcutaneous fat and improvements in triglycerides.3

• The effect does not outlast the drug. When patients were switched to placebo after 26 weeks, visceral fat reaccumulated.4

• A 2019 randomised trial found it reduced liver fat by 37 percent relative to baseline in people with HIV and fatty liver disease over 12 months.5

• A 20-week trial in 152 older adults without HIV found a favourable effect on cognition, particularly executive function. It has not been replicated at scale, and cognition is not an approved use.6

• The label carries contraindications for active malignancy, pituitary disruption and pregnancy, and warnings on IGF-1 elevation, glucose intolerance and fluid retention.2

• Prohibited in sport under WADA section S2, which names it.7

The Most Common Error About This Compound

Reading "FDA-approved" as approval of what it is being sold for. Tesamorelin is approved to reduce visceral fat in HIV-associated lipodystrophy. It is marketed by clinics and telehealth services for visceral fat in people without HIV, for body composition, for "anti-ageing" and for cognition, none of which is on the label, and the label states in terms that it "is not indicated for weight loss management as it has a weight neutral effect."2 The approval is real. It just belongs to a different patient.

Identity

What Is Tesamorelin?

Growth-hormone-releasing hormone is the hypothalamic peptide that instructs the pituitary to release growth hormone. Given as a drug, it is destroyed within minutes. Tesamorelin, developed by Theratechnologies of Montreal as TH9507, is the full 44-residue human GHRH with a hexenoyl group attached to the N-terminal tyrosine, which blocks the enzyme that cleaves it and extends its action enough to be given once daily.1

Because it works through the pituitary, it preserves the feedback loops that direct growth hormone injection bypasses: growth hormone is released in pulses, and IGF-1 rises but tends to stay in the physiological range. That is the pharmacological argument for a GHRH analogue over growth hormone itself, and the Phase 3 data bear it out on glucose, where growth hormone at comparable effect sizes had caused problems.3

Which Product?

The WR label states the two current formulations "are not substitutable" and carry different doses, reconstitution instructions and storage requirements.2 The 1.28 mg dose of the more concentrated formulation is bioequivalent to the 2 mg dose of the older one; a person switching between them needs to know which they have.

Theratechnologies was acquired in 2025 by CB Biotechnology, an affiliate of Future Pak, a contract manufacturer.8 The product remains on the market under the same name.

Evidence Base

What Did the Approval Trials Show?

Two multicentre, randomised, placebo-controlled Phase 3 trials with the same design: 26 weeks of 2 mg daily versus placebo in people with HIV on antiretroviral therapy who had excess abdominal fat, followed by a 26-week extension in which those on drug were re-randomised to continue or switch to placebo.

The first, published in the New England Journal of Medicine, randomised 412 people, 86 percent men. Visceral adipose tissue on CT fell 15.2 percent on tesamorelin and rose 5.0 percent on placebo; triglycerides fell 50 mg/dL against a rise of 9; IGF-1 rose 81 percent. Adverse events did not differ overall, but more people withdrew from the tesamorelin group because of one.1

The pooled analysis of both trials, 806 people, gives the figures on the label: a 15.4 percent treatment effect on visceral fat at 26 weeks, no significant change in subcutaneous fat, improvements in triglycerides and cholesterol ratio, and improved patient and physician ratings of belly appearance. At 52 weeks in those who stayed on drug, the visceral fat reduction was 17.5 percent from baseline. Glucose parameters showed no clinically meaningful differences.3

A 2026 systematic review and meta-analysis of four randomised trials in 909 patients confirmed the picture: reduced visceral fat, waist circumference and trunk fat, a 1.42 kg increase in lean mass, modest lipid improvement, and growth-hormone-related adverse effects with a higher discontinuation rate.9

What Happens When It Stops?

The fat comes back. In the extension phase, patients switched from tesamorelin to placebo at week 26 reaccumulated visceral fat, and the authors state that although the effects are sustained during treatment for 52 weeks, "these effects do not last beyond the duration of treatment."4

That makes tesamorelin a maintenance drug rather than a course, which matters for cost and for the risk calculus. The label's own limitation of use says to "consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue," and that long-term cardiovascular safety has not been established.2

What About the Liver?

This is the most substantial evidence beyond the label, and it is still in people with HIV.

A 2014 trial of 50 people with HIV and abdominal fat found tesamorelin reduced visceral fat and, additionally, modestly reduced liver fat over six months.10 The follow-up, a randomised, double-blind, multicentre trial in 61 people with HIV and non-alcoholic fatty liver disease, found a 4.1 percentage point absolute reduction in hepatic fat fraction at 12 months, a 37 percent relative reduction, with 35 percent of the tesamorelin group reaching a fat fraction under 5 percent against 4 percent on placebo. Glucose and HbA1c did not differ. Injection-site complaints were more common.5 A later analysis confirmed the effect in people on integrase inhibitors, the current standard antiretroviral class.11

Liver fat is not an approved indication. It is the most likely candidate for one.

What About Cognition?

One trial, and it is the source of most of the "anti-ageing" marketing.

In 2012, 152 adults aged 55 to 87, 66 with mild cognitive impairment and the rest healthy, self-injected 1 mg tesamorelin or placebo nightly for 20 weeks. The intent-to-treat analysis found a favourable effect on cognition, most clearly on executive function, in both groups. IGF-1 rose 117 percent, body fat fell 7.4 percent, and fasting insulin rose 35 percent in the cognitively impaired group. Adverse events were mild but reported by 68 percent on drug against 36 percent on placebo.6 A substudy found increased GABA in three brain regions.12

Fourteen years on, no larger trial has followed. A 2025 open-label Phase 2 trial in 73 people with HIV and abdominal obesity found no significant difference in cognition against standard care, with the authors noting the study's insufficient power and lack of placebo.13 One positive trial with a 20-week horizon is a reason to run another. It is not a treatment.

Is There Evidence in People Without HIV?

Very little, and the little that exists was designed to answer safety questions rather than efficacy ones. A 12-week randomised trial in 53 people with type 2 diabetes found tesamorelin did not alter insulin response or glycaemic control, which addressed the main concern for that population.14 The cognition trial is the other. Nobody has run a controlled trial of tesamorelin for visceral fat in people without HIV, which is the use most clinics now sell it for.

Safety

What Does the Label Say?

Tesamorelin is contraindicated in people with disruption of the hypothalamic-pituitary axis, with active malignancy, with hypersensitivity to it, and in pregnancy. Its warnings cover increased risk of neoplasms, because it raises growth hormone and IGF-1 and any pre-existing cancer should be inactive before starting; elevated IGF-1, whose long-term effects are unknown and which should be monitored; fluid retention including oedema, joint pain and carpal tunnel syndrome; glucose intolerance or diabetes; hypersensitivity reactions; and increased mortality in acute critical illness. The most common adverse reactions, over 5 percent, are joint pain, injection-site redness and itching, limb pain, peripheral oedema and muscle pain.2

What Is Actually Known About Cancer Risk?

Nothing definitive, and the label is honest about that. The concern is mechanistic: IGF-1 is a growth factor, and the label says the effects of prolonged elevation "are unknown." The trials excluded people with active cancer and ran for a year. The population in which the drug was approved has an elevated background cancer risk, which the label tells prescribers to weigh.2

For a person using the drug off-label for years, the honest answer is that the monitoring the label requires, IGF-1 and glucose, is the whole of the available protection, and that a clinic which does not do it is not prescribing the drug as approved.

Sport and Drug Testing

Is Tesamorelin Prohibited?

Yes. WADA's Prohibited List names it under S2 as a growth-hormone-releasing hormone analogue, prohibited at all times. A therapeutic use exemption is possible for its approved indication and would be assessed on that basis.7

Can It Be Detected?

Yes. Anti-doping laboratories have characterised tesamorelin's metabolites alongside those of sermorelin and CJC-1295 and published urine methods reaching WADA's required limits.15

Regulatory Status

Where Is It Approved?

In the United States, for HIV-associated lipodystrophy, since 10 November 2010. Tesamorelin is described in the literature and by its manufacturer as the only approved therapy for that condition.11 It has not been approved by the European Medicines Agency, and ONPEPS is not aware of any approval outside North America.

Can It Be Compounded?

Here tesamorelin differs from every unapproved peptide in this library, and the difference cuts both ways.

Because it is the active ingredient of an approved drug, tesamorelin is eligible for compounding by 503A pharmacies without needing to be on a bulks list. But compounding is not permitted to produce what is "essentially a copy" of a commercially available drug. The FDA's guidance treats a compounded product with the same active ingredient, a similar or easily substitutable strength and the same route as essentially a copy unless a prescriber documents a change that produces a significant difference for the individual patient.16

Compounded tesamorelin is therefore lawful in a narrow case and unlawful in the common one. A pharmacy making a subcutaneous tesamorelin injection at a dose equivalent to the approved product, for a patient who could take the approved product, is making a copy. Cost is not a difference the guidance accepts. The sourcing page covers what that means for the product actually in circulation.

Related ONPEPS Coverage

• Tesamorelin sourcing and quality: the approved product, the copy and the vial

• Tesamorelin cost and access: a specialty drug with one indication

• CJC-1295: the GHRH analogue that did not finish its trials

• Ipamorelin: the secretagogue it is usually stacked with

• Semaglutide: what an approved drug for weight itself looks like

What Would Change This Page

A controlled trial of tesamorelin for visceral or liver fat in people without HIV, which would test the use it is most often sold for. A larger cognition trial. A long-term cardiovascular or cancer outcome study, which the label identifies as the open question. Trials in HIV populations are ongoing, including one at Massachusetts General Hospital recruiting since 2025, but none addresses the off-label market directly.17

References

1. Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2359-2370. Open access. pubmed.ncbi.nlm.nih.gov/18057338

2. Theratechnologies Inc. EGRIFTA WR (tesamorelin) for injection: prescribing information. Revised March 2025. DailyMed. dailymed.nlm.nih.gov

3. Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291-4304. Open access. pubmed.ncbi.nlm.nih.gov/20554713

4. Falutz J, Allas S, Mamputu JC, Potvin D, Kotler D, Somero M, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22(14):1719-1728. Paywalled. pubmed.ncbi.nlm.nih.gov/18690162

5. Stanley TL, Fourman LT, Feldpausch MN, Purdy J, Zheng I, Pan CS, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. 2019;6(12):e821-e830. Open access. pubmed.ncbi.nlm.nih.gov/31611038

6. Baker LD, Barsness SM, Borson S, Merriam GR, Friedman SD, Craft S, Vitiello MV. 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;69(11):1420-1429. Open access. pubmed.ncbi.nlm.nih.gov/22869065

7. World Anti-Doping Agency. The Prohibited List, section S2. Current edition. wada-ama.org

8. Theratechnologies Inc. Theratechnologies enters into definitive agreement to be acquired by CB Biotechnology, an affiliate of Future Pak. Press release, 3 July 2025. globenewswire.com

9. Ditta AM, Naeem RM, Sami MM, Abdul Rafey M, Ali H, Amjad MW, et al. Efficacy and safety of tesamorelin in people living with HIV (PLWH) with lipodystrophy: a systematic review and meta-analysis. J Int Assoc Provid AIDS Care. 2026;25:23259582261475549. Open access. pubmed.ncbi.nlm.nih.gov/42538058

10. Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312(4):380-389. Open access. pubmed.ncbi.nlm.nih.gov/25038357

11. Russo SC, Ockene MW, Arpante AK, Johnson JE, Lee H, Toribio M, et al. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS. 2024;38(12):1758-1764. Open access. pubmed.ncbi.nlm.nih.gov/38905488

12. Friedman SD, Baker LD, Borson S, Jensen JE, Barsness SM, Craft S, et al. Growth hormone-releasing hormone effects on brain γ-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurol. 2013;70(7):883-890. Open access. pubmed.ncbi.nlm.nih.gov/23689947

13. Ellis RJ, Vaida F, Hu K, Dube M, Henry B, Chow F, et al. Effects of tesamorelin on neurocognitive impairment in persons with HIV and abdominal obesity. J Infect Dis. 2025;231(5):1230-1238. Paywalled. pubmed.ncbi.nlm.nih.gov/39813152

14. Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: a randomized, placebo-controlled trial. PLoS One. 2017;12(6):e0179538. Open access. pubmed.ncbi.nlm.nih.gov/28617838

15. Memdouh S, Gavrilović I, Ng K, Cowan D, Abbate V. Advances in the detection of growth hormone releasing hormone synthetic analogs. Drug Test Anal. 2021;13(11-12):1871-1887. Open access. pubmed.ncbi.nlm.nih.gov/34665524

16. US Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. January 2018. fda.gov

17. ClinicalTrials.gov. Studies listing tesamorelin as an intervention. Registry search; recruiting status changes continuously. Checked 16 September 2026. clinicaltrials.gov

Not Medical Advice

Tesamorelin is an approved prescription medicine for one indication, with contraindications and monitoring requirements set out in its label, and it is prohibited in sport under WADA section S2. Nothing here is a substitute for that label or for a prescriber who has read it. Consult a qualified healthcare provider before acting on anything here.

Evidence counts on the library index retrieved 23 July 2026. Literature, label and regulatory sources verified 16 September 2026. Re-verify before relying on any regulatory statement here.