Tesamorelin

Egrifta, Egrifta SV, Egrifta WR, TH9507, tesamorelin acetate

Growth hormone axis

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Note on this profile. Tesamorelin is an approved prescription medicine (Egrifta) in the United States and Canada for reducing excess abdominal fat in adults with HIV and lipodystrophy. Every other use — including fat loss in people without HIV, "anti-ageing", cognition or liver fat — is off-label or investigational. This page explains the published science; grey-market tesamorelin is not the approved product.

Summary

Class: Synthetic 44-amino-acid analogue of full-length human GHRH (1-44) with a trans-3-hexenoic acid group on the N-terminus that protects it from enzyme breakdown
Mechanism: Stimulates the pituitary GHRH receptor to increase pulsatile growth hormone release, which raises IGF-1 and preferentially mobilises visceral (deep abdominal) fat
Routes studied: Subcutaneous injection, once daily
Dose range reported: Approved: 2 mg subcutaneous once daily (Egrifta SV 2 mg/vial; Egrifta WR 1.28 mg/vial as a different-strength formulation delivering an equivalent dose) †. Trials used 1 mg and 2 mg daily. Community reports follow the 1–2 mg/day label range, sometimes 5 days a week
Half-life: ~26–38 minutes in healthy adults; ~38 minutes in people with HIV. GH peak at ~15–30 minutes
Storage: Egrifta SV: room temperature before reconstitution; reconstitute with sterile water and inject immediately — the label says to discard any unused portion. Research lyophilised material: refrigerate; community practice is to refrigerate reconstituted solution for up to ~2–4 weeks, which departs from the label
Regulatory status: Approved medicine (US 2010; Canada 2014); not authorised in the EU, UK or Australia

Doses are as reported in studies or by the community — never recommendations.

1What it is

Tesamorelin is GHRH with a small chemical cap on one end. Natural GHRH is cut apart within minutes by the enzyme DPP-4; the hexenoyl group blocks that first cut, extending the molecule's life enough to work as a daily injection while preserving the natural pulse pattern of GH release. It was developed by Theratechnologies in Montreal and approved by the FDA in 2010 for HIV-associated lipodystrophy — the deep abdominal fat gain that older antiretroviral regimens caused and that remains a problem for some patients.

It is the only GHRH analogue with large Phase 3 trials and a current approval anywhere, which makes it the best-evidenced compound in this category. It is also much better studied for one specific fat depot in one specific population than for anything else, and the US price has made grey-market versions attractive to people using it off-label.

2How it's thought to work

Pituitary. binds GHRH receptors, increasing GH synthesis and release while leaving feedback intact (somatostatin and IGF-1 can still dampen it), so GH stays pulsatile and IGF-1 rises modestly rather than dramatically.

Visceral fat. GH is strongly lipolytic in visceral adipose tissue, which has a high density of GH receptors; reductions in visceral fat of 15–20% are seen with little change in fat.

Liver fat. GH reduces hepatic de novo lipogenesis; tesamorelin lowered liver fat in people with HIV and fatty liver.

Metabolism. GH raises glucose; in trials, glucose rose transiently and returned toward , but this is the main metabolic trade-off.

Brain. GHRH has direct effects on sleep and cognition in older adults, independent of IGF-1, which prompted cognitive trials.

More growth hormone from the pituitary raises IGF-1 from the liver and shrinks visceral fat, the deep fat around the abdominal organs.Schematic — not to scale

3What the research shows

Visceral fat in HIV lipodystrophy

Two 26-week Phase 3 (n=412 and n=404) showed visceral adipose tissue fell about 15–18% with 2 mg/day versus roughly a 2–5% rise with placebo, with improvements in waist circumference, triglycerides and patient-reported body image (Falutz 2007, NEJM; Falutz 2010, J Clin Endocrinol Metab). Fat returned within 26 weeks of stopping. IGF-1 rose but mostly stayed within the normal range. [1][2]

Liver fat (NAFLD) in HIV

A 12-month RCT (n=61) showed tesamorelin reduced liver fat fraction by about 30% relative and prevented progression of fibrosis compared with placebo (Stanley 2019, Lancet HIV). A trial in NAFLD without HIV is underway or completed †. [3]

Graded A (small/older)

Abdominal obesity without HIV

Earlier Phase 2 work in non-HIV abdominal obesity (12 weeks) reduced visceral fat and triglycerides modestly (Stanley 2011, J Clin Endocrinol Metab). Not approved for this. [4]

Graded A (small)

Cognition in older adults

A 20-week RCT in 152 healthy older adults and adults with mild cognitive impairment reported improved executive function and verbal memory versus placebo, with increased IGF-1 and some rise in glucose (Baker 2012, Arch Neurol). A follow-on study reported changes in brain GABA and other metabolites (Friedman 2013). Not replicated at scale; no approval. [5][6]

Graded B/C

Peripheral nerve injury, muscle and ageing

Small studies and animal work; pilot trial in recovery after surgery. Preclinical or preliminary.

Body composition in healthy, non-obese adults

No published controlled trials. Community reports of fat loss and "better sleep" are anecdotal and extrapolated from the HIV data.

4Reported side effects and interactions

Literature-reported

Literature (label and trials). injection-site reactions (erythema, pruritus, pain, irritation, bruising) in roughly a quarter of patients; arthralgia and extremity pain, peripheral oedema, myalgia, paraesthesia and carpal tunnel symptoms, nausea, rash, hypersensitivity reactions including urticaria (anti-tesamorelin antibodies developed in about half of patients, mostly without clinical effect but linked to some hypersensitivity). Metabolic: increased fasting glucose and HbA1c in some patients, with new-onset diabetes in a small percentage; the label requires glucose monitoring. Fluid retention. Theoretical and label-stated: IGF-1 is a growth factor — tesamorelin is contraindicated in active malignancy and with pituitary tumours or surgery, hypophysectomy, head irradiation or trauma; contraindicated in pregnancy (fat redistribution is normal in pregnancy and GH excess could harm the fetus). Retinopathy was assessed because of GH's theoretical effect; no clear signal.

Community-reported

injection-site welts and itching (very common), joint stiffness, puffy hands and face, tingling fingers, headache, flushing shortly after dosing, increased appetite in some, deeper sleep in others.

Interactions. tesamorelin can alter the metabolism of drugs cleared by cytochrome P450 enzymes because GH affects CYP activity — the label advises monitoring narrow-therapeutic-index drugs such as warfarin, antiepileptics, cyclosporine. Glucocorticoids blunt the GH response. Interaction with insulin and oral hypoglycaemics via raised glucose. Additive GH release with GHRPs (community combination; untested).

Markers researchers commonly monitor

Marker	Why it's watched
IGF-1	the label advises monitoring IGF-1 during treatment and considering discontinuation if it rises persistently above the upper reference limit (the trials used an IGF-1 Z-score > 3 as a threshold).
Fasting glucose and HbA1c	the label requires glucose assessment before and during treatment; new or worsening hyperglycaemia is the main metabolic concern.
Waist circumference and visceral fat (CT or DEXA)	the approved endpoint; the label suggests reassessing whether treatment is still working.
Triglycerides and lipid panel	improved in trials.
Liver enzymes and liver fat imaging	relevant given the NAFLD data.
Fluid retention, joint symptoms, wrist/hand paraesthesia	practical GH-excess signs.
General baseline CBC, CMP

Free for everyone. Safety information is never behind a paywall.

5Reconstitution and handling

The approved product (Egrifta SV) is a 2 mg vial with 0.5 ml sterile water, swirled gently and injected immediately into abdominal tissue, with the remainder discarded; the newer Egrifta WR is designed for once-weekly reconstitution of a multi-dose vial †. Research-grade vials (2 mg, 5 mg, 10 mg) are typically reconstituted with and refrigerated; note that this is community practice and differs from the single-use label instruction.

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6Commonly studied alongside

Ipamorelin (community pairing for synergistic GH release; no trial), metformin or GLP-1 agonists (clinical context of metabolic management; no formal combination trial), antiretroviral therapy (the population in which it is approved).

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	FDA-approved (Egrifta 2010; Egrifta SV 2018; Egrifta WR 2025 †) for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. Prescription-only; other uses off-label. Compounded tesamorelin availability is limited and legally contested †
European Union	Not authorised; a 2014 EMA marketing authorisation application was withdrawn by the company
United Kingdom	Not licensed
Australia	Not approved; GHRH analogues are prescription-only (Schedule 4)
South Africa	Not registered
Sport	Prohibited by WADA (S2 — GHRH analogues; tesamorelin is named on the list)

8Open questions

Does tesamorelin help abdominal obesity or fatty liver in people without HIV at acceptable metabolic cost? Trials exist but no approval.
Do cognitive benefits in older adults hold up in larger trials?
Long-term safety beyond 52 weeks, particularly glucose metabolism and any effect on cancer risk through IGF-1.
Visceral fat returns on stopping — is intermittent or maintenance use viable?

9References

1Falutz J et al. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. PubMed · DOI
2Falutz J et al. (2010). 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. PubMed · DOI
3Stanley TL et al. (2019). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. PubMed · DOI
4Stanley TL et al. (2011). Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab. PubMed · DOI
5Baker LD et al. (2012). 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. PubMed · DOI
6Friedman SD et al. (2013). Growth hormone-releasing hormone effects on brain γ-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurol. PubMed · DOI
7Egrifta / Egrifta SV (tesamorelin for injection) prescribing information, Theratechnologies (current label). PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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Self-reported side effects Phase 2

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11Page history

25 Oct 2026Profile published — awaiting medical review

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