Tesamorelin vs Sermorelin: The Approved GHRH Analogue and the Withdrawn One
Two GHRH analogues, both once FDA-approved. Tesamorelin is still approved, for abdominal fat in HIV. Sermorelin's approvals were withdrawn in 2009.
The short version
Tesamorelin and sermorelin both copy growth hormone-releasing hormone to make the pituitary release its own growth hormone. Tesamorelin is a current FDA-approved medicine, for reducing excess abdominal fat in adults with HIV and lipodystrophy, backed by randomised trials in that group. Sermorelin was approved for children with growth hormone deficiency until its maker stopped selling it. Neither has been tested in healthy adults for the uses they are sold for.
- Tesamorelin is the full 44-amino-acid GHRH sequence with an added group; sermorelin is the first 29 amino acids.
- Tesamorelin is currently FDA-approved, for excess abdominal fat in HIV-infected adults with lipodystrophy.
- Its own label says it is not indicated for weight loss management.
- Sermorelin's approvals were withdrawn in 2009 at the sponsor's request, and FDA says not for safety or effectiveness.
- Both are prohibited in sport at all times under WADA S2.2.4.
Tesamorelin and sermorelin are the only two growth hormone-releasing hormone (GHRH) analogues FDA has ever approved. Both act on the same pituitary receptor, and both were developed for a specific diagnosed condition.
Tesamorelin is still approved. Sermorelin left the market in 2008 when its sponsor stopped selling it. Both are now sold for body composition in healthy adults, a use neither was approved or tested for.
Side by side
| Tesamorelin | Sermorelin | |
|---|---|---|
| What it is | The 44-amino-acid sequence of human GHRH with a hexenoyl group added at the N-terminus | GHRH(1-29)NH2: the first 29 amino acids |
| How it acts | On the pituitary GHRH receptor, releasing endogenous growth hormone | The same |
| Approved use | Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy | Diagnostic test (1990) and idiopathic growth hormone deficiency in children (1997) |
| Status now | Currently approved; label on DailyMed | Approvals withdrawn 2009, not for safety or effectiveness. Compounded on prescription |
| Trial population | Adults with HIV and abdominal fat accumulation | Children with growth hormone deficiency |
| Tested in healthy adults for body composition? | No trial located | No trial located |
| Evidence level on this site | Strong, for the approved indication | Limited |
| WADA 2026 | S2.2.4, prohibited at all times | S2.2.4, prohibited at all times |
Full pages: Tesamorelin · Sermorelin
Structure: the whole hormone versus the active fragment
Natural GHRH is 44 amino acids long. Sermorelin keeps residues 1 to 29. A 1999 review describes it as a 29 amino acid analogue of human GHRH that specifically stimulates growth hormone secretion from the anterior pituitary.
Prakash 1999 - Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57., in the references belowTesamorelin keeps all 44. Its FDA label describes it as a human growth hormone-releasing factor analogue made of the 44 amino acid sequence of human GRF. A hexenoyl group is attached to the tyrosine at the start of the chain.
The receptor and the mechanism are the same. The difference is who each drug was tested in, and how thoroughly.
Tesamorelin’s evidence: randomised, and in one population
Tesamorelin has the strongest evidence in this family, but only for one population.
- 404 HIV-infected patients with excess abdominal fat. This 12-month trial randomised them to tesamorelin or placebo. Over six months, visceral fat fell by 10.9% on tesamorelin against 0.6% on placebo, and by about 18% in those who continued for 12 months. The gains were rapidly lost in patients switched to placebo. Falutz 2010 - Falutz J, Potvin D, Mamputu JC et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-22., in the references below
- 50 HIV-infected patients. A randomised trial found reductions in visceral fat and modest reductions in liver fat over six months. The authors call it preliminary. Stanley 2014 - Stanley TL, Feldpausch MN, Oh J et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312(4):380-9., in the references below
- 38 people with HIV on integrase-inhibitor regimens. An analysis drawn from a randomised trial found declines in visceral and liver fat over 12 months. Russo 2024 - Russo SC, Ockene MW, Arpante AK et al. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS. 2024;38(12):1758-1764., in the references below
One randomised trial sits outside HIV. In 53 patients with type 2 diabetes, 12 weeks of tesamorelin did not alter insulin response or glycaemic control. Clemmons 2017 - Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One. 2017;12(6):e0179538., in the references below That is a safety question, not a fat-loss result.
Consistent findings across large trials or meta-analyses. Multiple randomised placebo-controlled trials, including a 404-patient trial and a JAMA trial, for the approved indication. The rating describes the approved use in adults with HIV-associated abdominal fat accumulation. No trial has tested healthy adults for body composition.
Sermorelin’s evidence: real, and in children
Sermorelin’s controlled evidence sits in paediatric growth hormone deficiency. The 1999 review found three things:
- Limited data supporting once-daily treatment in some prepubertal children.
- An effect on final adult height that was yet to be determined.
- Smaller height-velocity gains than with growth hormone itself.
Prakash 1999 - Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57., in the references below A six-month comparative trial in 43 prepubertal children found the lower sermorelin dose produced the lowest height velocity. The higher dose was comparable to growth hormone. Neyzi 1993 - Neyzi O, Yordam N, Ocal G et al. Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone. Acta Paediatr Suppl. 1993;388:16-21; discussion 22., in the references below
Small or uncontrolled human studies. Too little to settle the question either way. Controlled trials exist, but in children with growth hormone deficiency, and the review of them hedges the treatment data as limited. No randomised trial in healthy adults for the marketed outcomes.
Sermorelin is now sold to adults for sleep, body composition and aging. Tesamorelin is sold in the same grey channels for fat loss. In both cases the people buying it are not the ones it was tested in.
Does sermorelin burn belly fat?
No trial has shown that. Sermorelin’s controlled evidence is in prepubertal children with growth hormone deficiency, and it measured height velocity, not abdominal fat. Prakash 1999 - Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57., in the references below Neyzi 1993 - Neyzi O, Yordam N, Ocal G et al. Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone. Acta Paediatr Suppl. 1993;388:16-21; discussion 22., in the references below
Tesamorelin, not sermorelin, has randomised evidence for reducing abdominal fat, and that evidence is specific to adults with HIV and lipodystrophy. Falutz 2010 - Falutz J, Potvin D, Mamputu JC et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-22., in the references below A marketing claim that sermorelin burns belly fat has no trial behind it in the population it is sold to.
Regulatory status
Tesamorelin
US legal status - FDA-approved · prescription only
FDA-approved as EGRIFTA WR for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The label states it is not indicated for weight loss management. Requires a prescriber. Grey-market vials carry the name without the approval, the quality control or the indication.
The current label lists these contraindications:
- Disruption of the hypothalamic-pituitary axis
- Active malignancy
- Known hypersensitivity
- Pregnancy
Its warnings cover, among others, neoplasms, elevated IGF-1, fluid retention, and glucose intolerance or diabetes. These are the reasons it needs a prescriber.
Sermorelin
Sport
Both are growth hormone releasing factors under S2.2.4 of the WADA 2026 Prohibited List, prohibited at all times. A prescription does not change that. USADA’s guidance states that a therapeutic use exemption for sermorelin is highly unlikely to be approved.
What the comparison tells you
This is the one pairing in the family where both compounds went through a full development programme. Both reached approval for a diagnosed condition. One is still on the market. The other left it, and FDA found in 2013 that it was not withdrawn for safety or effectiveness reasons.
That makes them the best evidence for what a GHRH analogue can do: raise growth hormone and, in adults with HIV-associated abdominal fat, reduce visceral fat. It does not make either one a tested body-composition drug for healthy adults.
Related
Common questions
Is tesamorelin better than sermorelin?
It has much stronger evidence, but for one narrow use: reducing excess abdominal fat in adults with HIV and lipodystrophy. Sermorelin's trials were in children with growth hormone deficiency. Neither has been tested in healthy adults for body composition, so neither can be called better for that.
How are tesamorelin and sermorelin different chemically?
Sermorelin is the first 29 amino acids of growth hormone-releasing hormone. According to its FDA label, tesamorelin is the full 44 amino acid sequence of human growth hormone-releasing factor. A hexenoyl group is attached at the start of the chain. Both act on the same pituitary receptor.
What is tesamorelin approved for?
The current label indicates it for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The label also lists limitations of use: long-term cardiovascular safety has not been established, and it is not indicated for weight loss management.
Is sermorelin still FDA-approved?
No. Its two GEREF approvals, from 1990 and 1997, were withdrawn effective 18 June 2009 after the sponsor discontinued the products. In 2013 FDA determined they were not withdrawn for reasons of safety or effectiveness. Sermorelin now reaches patients through compounding pharmacies on prescription.
Can athletes use tesamorelin or sermorelin with a prescription?
Both are growth hormone releasing factors on the WADA Prohibited List under S2.2.4 and are prohibited at all times. A prescription does not change that. USADA states a therapeutic use exemption for sermorelin is highly unlikely to be approved.
Does sermorelin really burn belly fat?
No trial has tested that claim. Sermorelin's controlled trials were run in prepubertal children with growth hormone deficiency, measuring height velocity, not fat loss in adults. Tesamorelin is the family member with trial evidence for reducing abdominal fat, and only in adults with HIV-associated lipodystrophy.
Is 3 months of sermorelin enough?
There is no established duration, because no approval covers the adult use sermorelin is now sold for, and no trial has set a course length for it. The published paediatric trials ran for six months. Anyone taking sermorelin outside its withdrawn paediatric approval should get the course length, and whether to continue, from their prescriber.
Will tesamorelin make you stronger?
No trial I located tested tesamorelin for strength. Its randomised trials measured visceral and liver fat in adults with HIV, and glucose control in type 2 diabetes. Its label says it is not indicated for weight loss management. The nearest data in this family is an uncontrolled 6-week study of GHRH(1-29), sermorelin's sequence, in 11 older men. Two of 6 strength measures improved, and body composition did not change.
References (10 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Falutz J, Potvin D, Mamputu JC et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-22.Randomised trialPMID 20101189
- 2.Stanley TL, Feldpausch MN, Oh J et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312(4):380-9.Randomised trialPMID 25038357full text
- 3.Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One. 2017;12(6):e0179538.Randomised trialPMID 28617838full text
- 4.Russo SC, Ockene MW, Arpante AK et al. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS. 2024;38(12):1758-1764.Randomised trialPMID 38905488full text
- 5.Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57.StudyPMID 18031173
- 6.Neyzi O, Yordam N, Ocal G et al. Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone. Acta Paediatr Suppl. 1993;388:16-21; discussion 22.Randomised trialPMID 8329826
- 7.EGRIFTA WR (tesamorelin) - current prescribing information on DailyMed, including indication, limitations of use, contraindications and warnings. Initial US approval 2010.- DailyMed, National Library of Medicinelabel
- 8.Federal Register, 4 March 2013 - Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (Docket FDA-2012-P-1071). States both NDAs, their approval dates and indications, the 2008 discontinuation letters, and the withdrawal of approval effective 18 June 2009.- US Government Publishing Office (Federal Register)regulatory
- 9.USADA - Athletes, know sermorelin. States sermorelin is prohibited in sport and that a therapeutic use exemption is highly unlikely.- US Anti-Doping Agencyregulatory
- 10.WADA 2026 Prohibited List, section S2.2.4 - growth hormone releasing factors, naming sermorelin and tesamorelin (national anti-doping agency mirror, PDF).- World Anti-Doping Agency (mirrored by the Jamaica Anti-Doping Commission)regulatory