Tesamorelin (Egrifta)
The One FDA-Approved GH-Releasing Peptide (HIV Lipodystrophy)
Evidence grade 4 of 5, Strong. Read how the Atlas grades evidence.
The written rationale for this grade is still being prepared.
- FDA
- FDA Approved 2010 (Egrifta); F8/weekly formulation (Egrifta WR) approved later
Reference only. Not medical advice.
What can go wrong
Can cause GH-axis effects: fluid retention, arthralgia/joint pain, peripheral edema, and glucose intolerance/worsened insulin sensitivity; injection-site reactions are common. Effects on glucose warrant monitoring, particularly in metabolically vulnerable patients. As with all GH-raising agents, sustained IGF-1 elevation carries an unresolved theoretical oncologic concern; it is contraindicated in active malignancy.
This is something to take to a clinician. The Atlas can tell you what is known about tesamorelin (egrifta) in general. It cannot tell you what is happening in your body, and the difference matters most for exactly the symptoms that bring people to this page.
Tesamorelin is a stabilized 44-amino-acid analog of growth hormone-releasing hormone (GHRH), FDA-approved in 2010 as Egrifta to reduce excess visceral abdominal fat in adults with HIV-associated lipodystrophy. It is the clearest example of a GH-releasing peptide that passed full FDA review, useful context for the many unapproved GH secretagogues sold off-label. It is increasingly marketed off-label for general fat loss and anti-aging, which is outside its approved use.
Proof a GH-releasing peptide can clear the FDA, for one specific indication.
What people take it for
What it is taken for. Approval, where it exists, covers only some of these.
- HIV-associated lipodystrophy
- Reduction of excess visceral abdominal fat in adults with HIV-associated lipodystrophy, the sole FDA-approved indication
How it works
Tesamorelin binds pituitary GHRH receptors to stimulate pulsatile growth hormone secretion, raising IGF-1 and shifting adipose metabolism toward reduced visceral fat. Stabilization extends its functional half-life relative to native GHRH, enabling practical dosing while still working through the pituitary rather than supplying GH directly.
Approved indication is narrow
Tesamorelin's robust trial data are specifically in HIV-associated visceral fat, in which it reduced visceral adipose tissue by roughly 15% versus placebo. Extrapolating that to general weight loss, athletic performance, or anti-aging is not supported by its evidence base, and such use is off-label. It raises GH/IGF-1, so the same metabolic and theoretical oncologic cautions as other GH-axis interventions apply.
Safety in detail
Tesamorelin is FDA-approved only for HIV-associated lipodystrophy; other uses are off-label. It raises GH/IGF-1 and requires physician evaluation and monitoring, especially of glucose. Compounded off-label product carries additional risk.
What has to be monitored
The bloodwork this needs, and the reason it belongs with a clinician rather than a website.
- IGF-1
- Fasting glucose / HbA1c
- Fluid retention / joint symptoms
- Malignancy screening as appropriate
What people get wrong
Often saidTesamorelin is an FDA-approved fat-loss and anti-aging peptide
ActuallyIts FDA approval is specifically for visceral fat in HIV lipodystrophy. General fat-loss and anti-aging use is off-label and unproven.
Often saidBecause it is approved, the whole GH-secretagogue category is safe and proven
ActuallyTesamorelin's approval is drug- and indication-specific; ipamorelin, CJC-1295, and MK-677 are not approved and do not inherit its evidence.
Who profits, and who pushes back
Nobody is named here yet, because we have not done that work on this entry. Read that as unfinished. Somebody almost certainly sells this, and somebody almost certainly disputes it. Assume both until we have checked.
At a glance
- FDA approval
- 2010 (Egrifta), for HIV lipodystrophy
- Class
- Stabilized GHRH analog (44 aa)
- Developer
- Theratechnologies
- Approved benefit
- ~15% reduction in visceral adipose tissue vs placebo
- Newer formulation
- Egrifta WR (F8), weekly reconstitution
What this entry does not yet cover
What follows is unfinished work on our side, not a finding about Tesamorelin (Egrifta). A short entry is not a safe entry.
- Timeline. We have not built the dated record of research and regulatory events.
- Cost and market. We have not documented what it sells for or who sells it.
- Supply chain. We have not mapped where it is made.
- Who uses it. We have not documented the user groups.
- What could change. No forward-looking summary yet.
- How it compares. We have not set it against the alternatives.
- Children and teenagers. We have not checked what is known about younger people.
- Where we land. We have not taken a position on this yet.
Sources
The studies below are named and described, but not linked. You cannot open them from here and check our reading against them, which means this page is our summary of the literature rather than a document you can verify. Weigh it accordingly until the links exist.
The studies that matter
Pooled Phase 3 analysis (n~806)2010
~15.4% reduction in visceral adipose tissue vs placebo at 26 weeks (p<0.001) in HIV lipodystrophy
Egrifta WR (F8) approvallater
Reformulation enabling weekly reconstitution to improve adherence