Tesamorelin

Tesamorelin is a growth hormone-releasing factor analogue. Rather than supplying growth hormone directly, it acts further up the axis, on the pituitary, prompting the body's own release. That is the mechanism it shares with sermorelin and with the growth hormone secretagogues, and it is why the four get discussed together.

It is supplied as a powder for subcutaneous injection under the brand EGRIFTA, marketed in more than one vial strength. Its US application was originally approved in November 2010 and was deemed a biologics licence application in March 2020, under the transition that moved certain protein products to that pathway.

Tesamorelin's approval is for a specific population and a specific problem: excess visceral abdominal fat in adults with HIV-associated lipodystrophy. That is the indication the evidence was generated for and the one the label covers.

It is prescribed and marketed in wellness settings for other purposes. Prescribing outside a licensed indication is legal and routine across medicine — but it means the approval does not extend to that use, and the evidence base behind the approval was not built on that population.

If a clinic offers it to you, a fair question is which of those two situations you are in, and what the clinician's reasoning is for the second.

The practical gap is large. An approved product has been reviewed by FDA for safety, effectiveness and quality before marketing, carries a label describing what is known about it, and comes from a manufacturing process held to federal standards.

Several of the peptides marketed alongside it sit in a very different position. FDA has placed a number of them in a bulk-substances category reserved for substances that may present significant safety risks, citing immunogenicity risk for certain routes of administration, complexity in characterising the peptide and its impurities, and in several cases an absence of human safety data.

Tesamorelin is not in that category. That is a meaningful difference and it is worth knowing which side of it any compound you are offered falls on.

Tesamorelin's US application began life as a new drug application and was deemed a biologics licence application in March 2020. That was not a change to the product — it was a statutory transition that moved a defined set of protein products from the drug pathway to the biologics pathway on a single date.

The practical consequence is about copies. A drug approved under the drug pathway can be followed by a generic that establishes equivalence. A product regulated as a biologic cannot: any follow-on has to come through the biosimilar pathway, which is a substantially heavier evidentiary lift.

This is worth knowing because it explains something you will otherwise find puzzling — why a peptide approved well over a decade ago still has no cheap generic version, and why the low-cost supply in this space is compounded rather than generic.

• Is this the approved product, or a compounded preparation of the same molecule?
• Am I being prescribed this within its licensed indication, or outside it — and what is the reasoning?
• What monitoring is planned, and who reviews it?
• What is the total cost, and is any of it likely to be covered?

Dosing is determined by a licensed provider. We do not publish schedules for any compound on this site.

How we verify providers

• FDA — EGRIFTA (tesamorelin for injection) approval / label — retrieved 2026-08-06
• FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — retrieved 2026-08-06
• FDA — FD&C Act Provisions that Apply to Human Drug Compounding — retrieved 2026-08-06