Is tesamorelin FDA approved? Not in every form. Egrifta, the prescription brand, has an approval that dates to November 10, 2010 and applies to reducing excess abdominal fat in adults with HIV and lipodystrophy. That label does not cover general weight loss, ordinary belly fat, or anti-aging. Tesamorelin offered through Promise is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved.
That distinction matters more than the molecule's name. A brand, its labeled use, and a pharmacy-compounded preparation are three separate regulatory questions.
Is tesamorelin FDA approved? Not in every form
The agency's 2010 summary review records approval of the original Egrifta on November 10, 2010. The reviewed indication was narrow: reduction of excess abdominal fat in adults with HIV and lipodystrophy.
The name and presentation later changed, but the indication did not expand. FDA records show the 2 mg-per-vial Egrifta SV label version was approved November 2, 2018 in a supplement letter signed in January 2019. On March 25, 2025, the agency approved Egrifta WR as a new formulation and multidose presentation.
| Product milestone | Date | What changed | What did not change |
|---|---|---|---|
| Original Egrifta | November 10, 2010 | First U.S. approval of tesamorelin | The HIV-lipodystrophy indication |
| Egrifta SV | November 2, 2018 label; 2019 supplement record | A 2 mg single-dose-vial formulation | No new weight-loss or anti-aging indication |
| Egrifta WR | March 25, 2025 | New formulation and multidose presentation | The same HIV-lipodystrophy indication |
What the Egrifta approval actually covers
Egrifta's current label says it is for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. The March 2025 prescribing information also says it is not indicated for weight-loss management and notes that long-term cardiovascular safety has not been established.
The evidence behind that label studied a defined population. In a 2007 randomized trial of 412 adults with HIV and abdominal fat accumulation, visceral adipose tissue decreased 15.2% with tesamorelin and increased 5.0% with placebo over 26 weeks (Falutz et al., New England Journal of Medicine). A 2010 pooled analysis of two phase 3 trials reported a 15.4% treatment effect on visceral fat at week 26 in 806 participants (Falutz et al., Journal of Clinical Endocrinology & Metabolism).
Those results explain the specific label; they do not turn tesamorelin into a general weight-management drug. Tesamorelin for belly fat examines the visceral-fat evidence in depth, while what tesamorelin does covers the growth-hormone-releasing mechanism.
Why compounded tesamorelin is a different product
Compounding starts with a prescription for an individual patient and ends with a preparation made by a pharmacy. It does not reproduce the manufacturer's finished product or transfer Egrifta's review to another vial. FDA states plainly that compounded drugs do not undergo its premarket verification for safety, effectiveness, or quality.
That does not make agency review a marketing gate or a blanket warning. It tells the patient what has and has not been evaluated. The tesamorelin offered by Promise is compounded, not Egrifta. Promise also offers a tesamorelin and ipamorelin blend; that is a separate compounded preparation, and Egrifta's status does not extend to the blend.
Where section 503A and the bulks list fit
Section 503A is a conditional framework for patient-specific pharmacy compounding, not a second drug-review pathway. As of September 2026, FDA's current 503A bulk-substances page describes three possible bases for using a bulk substance: an applicable USP or NF monograph; status as a component of a product the agency has approved; or appearance on the 503A Bulks List when the first two routes do not apply. Tesamorelin is a component of Egrifta, so that component route is the relevant part of this framework.
The same page describes three interim categories for substances nominated to the separate bulks list. Category 1 means a sufficiently supported nomination remains under evaluation and may fall within an enforcement-discretion policy. Category 2 identifies potential significant safety risks. Category 3 means the nomination lacked enough information for evaluation. A category describes how the agency is handling a nominated substance; it does not confer review status on a finished compounded vial.
Other conditions still matter. FDA's section 503A provisions require a valid prescription for an identified patient and restrict regular or inordinate compounding of products that are essentially copies of commercially available drugs. Whether a specific prescription and preparation meets the applicable conditions depends on its facts.
Regulatory status is one input into care, and a licensed provider may still prescribe a compounded formulation when appropriate; that decision belongs to the patient and prescriber.
What a prescription review changes
The practical dividing line is accountability. A licensed prescriber can review why tesamorelin is being requested, consider the label's contraindications and monitoring issues, and decline when the medical history does not fit. A licensed U.S. compounding pharmacy dispenses against that prescription. Grey-market vials sold without a prescription provide neither relationship.
At Promise, a licensed provider reviews every request and may prescribe only when tesamorelin is medically appropriate; not everyone qualifies. That review is also where the narrow Egrifta indication is kept separate from any individualized decision about a compounded preparation.
When reading any tesamorelin offer, look for the product identity first: Egrifta or compounded, tesamorelin alone or a blend. Then look for the licensed prescriber and dispensing pharmacy. The molecule's name by itself cannot answer those questions.