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Also: Egrifta SV · Egrifta WR · tesamorelin acetate · TH9507 · TH-9507 · GRF analog · tesa · tesemorelin · tesamoralin · tesamorelix · tesamorilin · tesmorelin
Four separate measurements, never averaged. Independent evidence counts only studies with no sponsor attached. Methodology version v2.0-2026-10 · how we grade evidence
This is the exception in this cluster: an FDA-approved drug with a real Phase 3 programme. Approved on 10 November 2010 under application 022505 and marketed as EGRIFTA, later EGRIFTA SV and EGRIFTA WR. The approved indication, verbatim from the current label, is narrow: "EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy."
The label’s Limitations of Use matter more here than the indication. They state, verbatim: "Long-term cardiovascular safety of EGRIFTA WR has not been established"; "Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue"; "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect"; and "There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR." It is not approved for bodybuilding, general fat loss, anti-aging, performance or non-HIV visceral adiposity, and the regulator itself says it is weight-neutral.
The efficacy evidence is genuine and sits inside those limits. Two Phase 3 trials totalling 816 randomised patients reduced visceral fat by 15.2% and 10.9% against placebo, both P<0.001, with IGF-1 rising 81.0% in the first — mechanism and clinical effect confirmed in the same adequately powered trials, the only compound in this cluster where that is true. A separate 61-patient trial reduced hepatic fat fraction in HIV-positive adults with fatty liver disease; that is a real positive result and it is not an approved indication.
Three limits should be read alongside the approval. The effect is not durable: patients switched to placebo in an extension phase showed visceral fat change of +1.3% (p=0.432). The trials did not show that reducing visceral fat improves morbidity, mortality or antiretroviral adherence. And safety is established only for HIV-infected adults with lipodystrophy, at the labelled route and duration — there is no comparable dataset in healthy people, in people seeking cosmetic fat loss, or in athletes. The label carries no boxed warning but substantive warnings on neoplasms, elevated IGF-1, fluid retention, glucose intolerance and diabetes, hypersensitivity, injection site reactions and mortality in acute critical illness.
Despite being a legitimate prescription medicine, tesamorelin also circulates on the grey market, where 3.6% of samples failed identity testing. WADA prohibits it at all times. It is also frequently listed alongside GLP-1 drugs in grey-market catalogues despite an entirely different mechanism — and, again, the label states it is weight-neutral.
At a glance
Binds and stimulates pituitary GHRH receptors, increasing endogenous growth hormone secretion and consequently IGF-1, which increases lipolysis preferentially in visceral adipose tissue. This is confirmed in humans rather than proposed: in the pivotal Phase 3 trial IGF-1 rose 81.0% with tesamorelin against a 5.0% fall with placebo (P<0.001), alongside the measured reduction in visceral fat. Glycaemic measures did not differ significantly in that trial, while the label still requires glucose evaluation before and during treatment because glucose intolerance and diabetes are recognised risks of the class.
Dated determinations, each flagged for whether it is final and whether it covers safety only. A safety review is not an efficacy finding, and most reporting in this category conflates the two.
An approved prescription medicine can still be prohibited in sport; the two determinations answer different questions. Named alongside CJC-1293, CJC-1295 and sermorelin.
All four Limitations of Use, verbatim from the current label: "Long-term cardiovascular safety of EGRIFTA WR has not been established."; "Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue."; "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect."; "There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR." It is not approved for bodybuilding, general fat loss, anti-aging, performance or non-HIV visceral adiposity. One sentence of the regulator’s own label does more honest work against off-label marketing of this compound than any evidence grade.
The label carries no boxed warning but substantive warnings: increased background malignancy risk in HIV-positive patients, with the product not to be used in active malignancy and to be discontinued if a prior malignancy recurs; monitoring of IGF-1 with consideration of discontinuation if persistently elevated; edema, arthralgia and carpal tunnel syndrome; evaluation of glucose before and during therapy with monitoring for retinopathy in diabetics. Safety is established for HIV-infected adults with lipodystrophy at the labelled route and duration and not beyond that — there is no comparable safety dataset in healthy people, in people seeking cosmetic fat loss, or in athletes. A safety warning says nothing about whether the drug works; these rows and the efficacy rows should be read separately.
Approved 10 November 2010 under application 022505, originally an NDA and deemed a BLA on 23 March 2020. Marketed as EGRIFTA, later EGRIFTA SV and EGRIFTA WR; most recent supplement SUPPL-20 on 25 March 2025, currently prescription status and not discontinued. The indication verbatim: "EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." It is the only approval in this cluster, and it is narrow. It is not on FDA’s Category 2 list and was not reviewed by the compounding advisory committee — it does not need to be, because it is an approved prescription drug.
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