Sermorelin: What the Trials Studied, and Who They Studied It In

Sermorelin is one of the most-searched peptides we had never written about. It is also one of the easiest to describe inaccurately, because almost everything published about it is written by someone selling it, and the single most important fact about it is the one those pages leave out.

What sermorelin is

Sermorelin is GHRH(1-29)NH2: the first 29 amino acids of growth hormone-releasing hormone. The natural hormone is 44 amino acids long, and this fragment is the shortest piece that retains its full biological activity Ehlers 2001 - Ehlers MR. Recombinant human GHRH(1-44)NH2: clinical utility and therapeutic development program. Endocrine. 2001;14(1):137-41. (opens PubMed in a new tab).

The mechanism is indirect, and that is the whole pharmacological argument for it. Rather than supplying growth hormone, sermorelin acts on the pituitary and prompts it to release its own. The body’s somatostatin feedback stays in the circuit, so release stays pulsatile in a way that injected growth hormone is not.

Where the trial evidence actually sits

In children.

The controlled evidence for sermorelin is concentrated in paediatric growth hormone deficiency, which is the indication it was developed and approved for. Prakash and Goa reviewed its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency 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. (opens PubMed in a new tab). A multicentre comparative trial measured growth response to GHRH(1-29)-NH2 against growth hormone itself 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. (opens PubMed in a new tab). A randomised controlled trial related quantitative growth hormone secretion to final adult height Trainer 1999 - Trainer PJ, Palermo M, Kirk JM et al. Quantitative growth hormone secretion and final adult height. Clin Endocrinol (Oxf). 1999;51(5):597-602. (opens PubMed in a new tab).

That is a real evidence base. It is a real evidence base about children who were growing.

• Children with growth hormone deficiencythe approved indication
  3
• Adults with a diagnosed conditionIGF-1 biomarker, hypogonadal men
  1
• Healthy adults, marketed outcomessleep, fat loss, anti-aging
  0

The controlled evidence sits in children with growth hormone deficiency. The adults buying sermorelin for sleep, body composition and aging are not that population, and no trial we located tested those outcomes in healthy adults.

Where it does not sit

The adults being sold sermorelin today are not that population, and are not being sold that outcome. They are being sold sleep quality, fat loss, muscle tone, recovery and “anti-aging”.

We searched PubMed for sermorelin trials in adults tagged as randomised controlled trials. The result set is small, and reading it shows it is dominated by paediatric growth and by sermorelin’s other established role - as a diagnostic agent for testing pituitary function, which is a different job entirely from chronic treatment.

The nearest thing to adult evidence we located reports that growth hormone secretagogue treatment raised serum IGF-1 in hypogonadal men Sigalos 2017 - Sigalos JT, Pastuszak AW, Allison A et al. Growth Hormone Secretagogue Treatment in Hypogonadal Men Raises Serum Insulin-Like Growth Factor-1 Levels. Am J Mens Health. 2017;11(6):1752-1757. (opens PubMed in a new tab). Read that precisely: it is a biomarker moving, in men with a diagnosed hormonal condition. IGF-1 rising is the thing the drug is supposed to do. It is not the same as a healthy adult sleeping better or losing fat, and it was not measured in healthy adults.

The doses that were actually studied

We report doses where a study establishes one. Here they are, and they are more interesting than the round numbers circulating commercially.

For diagnosis, sermorelin was given as a single intravenous dose of 1 microgram per kilogram of bodyweight — a provocative test of whether the pituitary can release growth hormone at all 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. (opens PubMed in a new tab).

For treatment in children, the reviewed regimen is 30 micrograms per kilogram of bodyweight, once daily, subcutaneously, at bedtime, in prepubertal children with idiopathic growth hormone deficiency 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. (opens PubMed in a new tab). A comparative trial used a low-dose arm at 30 micrograms/kg/day split across three daily doses and a high-dose arm at 60 micrograms/kg/day 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. (opens PubMed in a new tab).

Two things about those figures deserve saying out loud.

The review that reports the 30 mcg/kg regimen hedges it in the same sentence — “limited data indicate” — and states plainly that the effect of long-term treatment on final adult height is yet to be determined. That is the approved indication, described cautiously by the literature covering it.

And in head-to-head terms it did not win. Height-velocity increases on sermorelin at 30 mcg/kg/day were less than in children given growth hormone itself at the same 30 mcg/kg/day 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. (opens PubMed in a new tab).

Its regulatory position, stated carefully

Sermorelin has a regulatory history, and it is the fact the rest of the page depends on. Here it is from the FDA’s own record rather than from anyone’s blog.

Two products were approved. GEREF injection at 0.5 and 1.0 mg base/vial was NDA 20-443, held by EMD Serono, approved on 26 September 1997. GEREF injection at 0.05 mg base/amp was NDA 19-863, approved on 28 December 1990. In letters dated July and December 2008, EMD Serono told the FDA the products were being discontinued and asked for the newer NDA to be withdrawn. The FDA moved them to the Orange Book’s Discontinued Drug Product List.

Then comes the part almost nobody writing about sermorelin mentions. In 2013 the FDA formally determined that these products were not withdrawn from sale for reasons of safety or effectiveness — a determination published in the Federal Register under docket FDA-2012-P-1071.

If you compete, this one is simple

Sermorelin is prohibited in sport. USADA states it plainly: “Yes, Sermorelin is prohibited due to its ability to enhance muscle growth, endurance, and recovery by boosting endogenous hGH production.” It sits in the growth hormone releasing factors section of the WADA Prohibited List — the same section that covers CJC-1295 — and substances there are prohibited at all times, not only in competition.

The part worth knowing before you ask is the exemption question. Per USADA, “it is highly unlikely a TUE would be approved for Sermorelin, as it is not a first-line treatment for growth hormone deficiency and there are alternative treatments available.” A therapeutic use exemption is not a formality you file after the fact; if you are tested, a prescription from a wellness clinic will not retroactively make this allowed.

If you are considering it

Sermorelin is a prescription-only compound. That is not a technicality to route around - it is the part of this that gives you a clinician, bloodwork, and someone accountable for the decision.

References

Bibliographic detail is fetched from PubMed, not written by us - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than our judgement.

1. 1.Ehlers MR. Recombinant human GHRH(1-44)NH2: clinical utility and therapeutic development program. Endocrine. 2001;14(1):137-41.StudyPMID 11322496
2. 2.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
3. 3.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
4. 4.Trainer PJ, Palermo M, Kirk JM et al. Quantitative growth hormone secretion and final adult height. Clin Endocrinol (Oxf). 1999;51(5):597-602.Randomised trialPMID 10594520
5. 5.Sigalos JT, Pastuszak AW, Allison A et al. Growth Hormone Secretagogue Treatment in Hypogonadal Men Raises Serum Insulin-Like Growth Factor-1 Levels. Am J Mens Health. 2017;11(6):1752-1757.StudyPMID 28830317full text

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