TesamorelinGrowth Hormone
GHRH analog studied for visceral fat reduction.
- Status
- Prescription
- Developer
- Theratechnologies (TH9507); FDA-approved as Egrifta
- Receptors / target
- Stabilized GHRH (growth-hormone-releasing factor) receptor agonist; stimulates pituitary GH and downstream IGF-1 secretion
- FDA-approved?
- YES
- Prescription available?
- YES
- Studied for
- HIV-associated lipodystrophyvisceral fat reductionGH / IGF-1 axisNAFLD / hepatic fat
Overview
Tesamorelin (brand Egrifta; marketed as Egrifta SV and Egrifta WR) is a stabilized synthetic analog of growth-hormone-releasing hormone (GHRH/GRF). It is FDA-approved (2010) to reduce excess visceral abdominal fat in HIV-infected adults with lipodystrophy, given as a once-daily subcutaneous injection. The label explicitly notes it is not indicated for general weight loss and that long-term cardiovascular safety is unestablished. This profile reports trial and label findings, not treatment guidance.
Mechanism
Tesamorelin binds and stimulates pituitary GRF (GHRH) receptors, triggering synthesis and pulsatile release of the body's own growth hormone, which raises IGF-1 and promotes lipolysis of visceral fat. Because it amplifies the physiologic pulsatile GH axis rather than supplying exogenous growth hormone directly, it preserves more of the normal GH/IGF-1 feedback. Its half-life is short — roughly 8 minutes in healthy adults (somewhat longer in HIV patients).
Clinical evidence
Human evidence is strong. Two large double-blind, placebo-controlled phase 3 RCTs (Falutz et al., NEJM 2007, n=412; and a JAIDS 2010 trial with safety extension) showed tesamorelin 2 mg/day reduced visceral adipose tissue by roughly 11-15% versus placebo over 26 weeks, sustained with continued treatment. A later randomized, double-blind, multicenter trial (Stanley et al., Lancet HIV 2019) showed reduced liver fat and less fibrosis progression in HIV-associated NAFLD. This evidence is in HIV populations; data in non-HIV, healthy or athletic users are far more limited.
Safety profile
Per the FDA label, common adverse reactions include injection-site reactions, arthralgia, myalgia, pain in extremity and peripheral edema; fluid retention can manifest as edema, arthralgia and carpal-tunnel symptoms. Tesamorelin can cause glucose intolerance and elevates IGF-1, both of which require monitoring. Contraindications include disruption of the hypothalamic-pituitary axis, active malignancy, hypersensitivity and pregnancy, and long-term cardiovascular safety is not established. A prescription drug — these are observed findings, not dosing guidance.
- Weeks 2–4
IGF-1 rises soon after starting; injection-site reactions are the most common early effect.
- ~Week 26
Primary trial timepoint: roughly 11–15% reduction in visceral abdominal fat in the HIV-lipodystrophy RCTs (Falutz, NEJM 2007).
- After stopping
Visceral fat tends to re-accumulate once treatment is discontinued.
Reported in published literature and user reports. Not a complete list, and not medical advice.
- Injection-site reactions (erythema, pruritus, pain)
- Arthralgia and peripheral edema
- Fluid retention / carpal-tunnel symptoms
- Hyperglycemia / impaired glucose tolerance
If severe or unexpected symptoms occur, contact a qualified medical professional. PEPTIDES·INDEX does not provide medical advice.
- Disruption of the hypothalamic-pituitary axis (e.g. from hypophysectomy, hypopituitarism, pituitary tumor or surgery, or head irradiation/trauma) per the FDA label.
- Active malignancy; any pre-existing malignancy must be inactive and treatment completed before starting (FDA label).
- Pregnancy, and known hypersensitivity to tesamorelin or mannitol (FDA label).
- Insulin or other antidiabetic agentsTesamorelin can cause glucose intolerance and raise IGF-1; glucose status requires monitoring and antidiabetic regimens may need adjustment (per label)
- Cytochrome P450-metabolized drugs (e.g. corticosteroids, some others)GH can modulate CYP enzyme activity; the label advises monitoring drugs metabolized by CYP450 as their effectiveness may change
Compare
- vs Sermorelin
Native GHRH(1-29) with former FDA approval; tesamorelin is a stabilized, longer-acting analog with current approval.
- vs CJC-1295 DAC
An unapproved long-acting GHRH analog; useful contrast to this FDA-approved one.
FAQ
What is tesamorelin actually FDA-approved for?
Only for the reduction of excess visceral abdominal fat in HIV-infected adults with lipodystrophy (brand Egrifta). The label explicitly states it is not indicated for general weight loss, and long-term cardiovascular safety is not established.
How strong is the human evidence for tesamorelin?
Strong, but specific to HIV populations. Two large placebo-controlled phase 3 RCTs showed roughly 11-15% reduction in visceral fat over 26 weeks, and a later trial showed reduced liver fat in HIV-associated NAFLD. Data in non-HIV, healthy, or athletic users are far more limited.
Is tesamorelin banned in sport?
Yes. As a GHRH (growth-hormone-releasing factor) analog it is prohibited at all times under WADA category S2.
How is tesamorelin administered in its approved use?
As Egrifta it is given as a once-daily subcutaneous injection at the approved 2 mg dose. In the pivotal trials treatment was continued for at least 26 weeks; visceral fat tends to re-accumulate after stopping, so the benefit depends on ongoing use.
How does tesamorelin differ from sermorelin?
Both are GHRH-receptor agonists, but sermorelin is the native, unmodified GHRH(1-29) amide with only former FDA approval, while tesamorelin is a stabilized analog that resists enzymatic breakdown and holds current FDA approval for HIV-associated lipodystrophy.
What are the most common side effects of tesamorelin?
Per the FDA label the common adverse reactions include injection-site reactions, arthralgia, myalgia, pain in extremity and peripheral edema; fluid retention can show up as edema, joint pain or carpal-tunnel symptoms. It can also cause glucose intolerance and raise IGF-1, both of which require monitoring.
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Starting references for the library summary. These are not dosing instructions or medical advice.
For research-use educational context only. Not medical advice and not a recommendation to use any compound. Consult a qualified healthcare professional before any health decision.