Home / Compounds / Tesamorelin

Tesamorelin

GHRH analogue · Egrifta

UK status

Not licensed in the UK

Availability

Licensed in the US only

Evidence base

Human RCT for its licensed indication

Controlled drug

No, but WADA prohibited

Tesamorelin is the most useful compound in this register for understanding what a licence actually covers. It is a properly approved drug, it works for what it was approved for, and almost nobody buying it online has the condition it was approved for.

01What it is

Tesamorelin is a stabilised analogue of human growth hormone releasing hormone. Mechanically it belongs with CJC-1295 and sermorelin: it acts on the pituitary to increase release of the body's own growth hormone.

What separates it is that it went through a full development programme and was approved.

02How it came about

Tesamorelin was developed for a specific problem: some people on long-term HIV treatment develop abnormal fat redistribution, with excess visceral abdominal fat. Trials showed that raising growth hormone through a GHRH analogue reduced that visceral fat, and the FDA approved it on that basis in 2010.

It is described as the only FDA-approved GHRH analogue currently marketed. That fact gets recycled online as general validation of the whole GHRH category, which is not what an approval for one condition in one population means.

03UK legal and licensing status

Tesamorelin is FDA-approved in the United States, marketed as Egrifta, for the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. That is the entire indication. It is described as the only approved GHRH analogue currently marketed.

Athletes: WADA names tesamorelin under S2.2.4, alongside GHRH and its other analogues. Prohibited at all times, licensed status notwithstanding.

04How it works

It binds GHRH receptors in the pituitary, increasing growth hormone secretion, which in turn raises IGF-1. In its licensed population, that shifts fat distribution, specifically reducing visceral adipose tissue.

05What it is not

Claims that attach themselves to this compound and do not hold up.

• Not a general fat-loss drug. Its licence covers visceral fat in HIV-associated lipodystrophy. No trials support use in healthy adults for body composition.
• Not an anti-ageing treatment. Nothing in the approval addresses ageing, muscle, recovery or longevity.
• Not licensed in the UK. A US approval is not a UK one, and supply here for human use without MHRA authorisation is unlawful.
• Not exempt from anti-doping rules. Being an approved medicine somewhere does not remove it from the WADA list. It is named explicitly.

06What the evidence shows

Approval rests on randomised controlled trials in adults with HIV-associated lipodystrophy, showing reduction in visceral abdominal fat. This is real, regulator-assessed evidence, which is more than can be said for most of this register.

It is also narrow evidence. Trials in one condition, in one population, measuring one outcome. Extrapolating from it to healthy adults seeking body composition changes is exactly the move the explainer on reading claims warns about, and the trials that would test it have not been done.

07Reported harms

For its licensed use, the US prescribing information carries the full frequency table. Recognised effects across GHRH analogues include joint pain, swelling from fluid retention, injection site reactions and effects on glucose tolerance, the last of which matters given the metabolic context of the licensed population.

Product bought outside a regulated supply chain carries the usual unverifiable identity, purity and sterility risks, and would fall outside the Yellow Card scheme.

08Interactions and cautions

Its US prescribing information covers interactions for its licensed use. Effects on glucose tolerance matter particularly, given the metabolic context of the population it is approved for. There is no UK SPC.

09Stopping

In its licensed use, the visceral fat reduction is not maintained after stopping, so the treatment is ongoing rather than a course. That is worth knowing for anyone imagining a short cycle.

10Monitoring

In its licensed use, a specialist would track IGF-1, glucose tolerance and the fat distribution being treated. Outside that context, nobody is monitoring anything, and effects on glucose metabolism are the specific reason that matters.

11Questions worth asking

Take these to a doctor or pharmacist. A good clinician will not mind being asked, and the answers are specific to you in a way nothing on this page can be.

1. Do I actually have the condition this is licensed for?
2. If not, what is the evidence that it does anything for what I want?
3. What would raising growth hormone long-term do to my glucose control?

12Common questions

13Sources

Links go to the authoritative source. Where a document sits behind a paywall or moves around, the full citation is given so you can find it yourself.

1. US prescribing information for EgriftaFDA
2. Prohibited List, S2.2.4 growth hormone releasing factorsWADA
3. Tesamorelin trials in HIV-associated lipodystrophyPubMed
4. Unlicensed medicines guidanceMHRA