Sermorelin is the rare peptide in this category that genuinely was an FDA approved drug. It was approved for children who were not growing, and for a diagnostic test. Almost everything it is sold for today is something it was never approved to do.
The short version. Sermorelin was an FDA approved drug, Geref, for two narrow uses: testing whether a child's pituitary could release growth hormone, and treating children with idiopathic growth hormone deficiency. The manufacturer stopped making it in 2008 and the FDA later confirmed that was not for safety or effectiveness reasons. It was never approved for adults, ageing, sleep or body composition.
Sermorelin is a synthetic peptide of 29 amino acids that matches the first 29 amino acids of human growth hormone-releasing hormone, the signal the hypothalamus sends to tell the pituitary to release growth hormone. A 1999 review in BioDrugs by Prakash and Goa describes it as the shortest synthetic peptide with the full biological activity of that hormone. Sermorelin does not replace growth hormone. It asks the pituitary to make more of its own, which is why its effect depends on a pituitary that still responds, and why the approved diagnostic use was precisely a test of that response.
Sermorelin has a real approval history, which is what separates it from almost every other peptide sold alongside it. The dates below come from the FDA's own Federal Register notice of 4 March 2013 (78 FR 14095, docket FDA-2012-P-1071).
| When | What happened | What it means |
|---|---|---|
| 28 December 1990 | Geref 0.05 mg ampoule approved, NDA 19-863 | Diagnostic use: evaluating the pituitary's ability to secrete growth hormone. |
| 26 September 1997 | Geref 0.5 mg and 1.0 mg vials approved, NDA 20-443 | Treatment of idiopathic growth hormone deficiency in children with growth failure. Children only. |
| July and December 2008 | EMD Serono discontinues the ampoule, then the vials | A manufacturer decision. |
| 18 June 2009 | FDA withdrawal of both approvals takes effect (74 FR 23407) | From this date there is no approved sermorelin product. |
| 4 March 2013 | FDA determines Geref was not withdrawn for reasons of safety or effectiveness | Allows the FDA to consider generic applications. Also the basis on which compounders prepare it. |
The 2013 determination is the most important document in this story and also the most over-read. It says the product did not leave the market because it was unsafe or did not work. It does not say sermorelin is safe or effective for anything beyond the two uses on its label, and it does not approve any new use. A page that cites the 2013 notice as evidence that sermorelin works for adult ageing is using a document about why a paediatric product was discontinued to support a claim the document never makes.
Sermorelin sits in a different legal position from BPC-157 or TB-500. Under section 503A, a compounding pharmacy may use a bulk substance that has a USP monograph, that is a component of an FDA-approved drug, or that appears on the 503A Bulks List. Compounders prepare sermorelin by prescription through the second door, relying on Geref's approval history and the 2013 determination. It is not on the Bulks List, and the FDA's page on 503A bulk substances, updated 14 May 2026, does not name it. The FDA has not published a sermorelin-specific statement confirming that reading, so the position is an established practice rather than an explicit ruling. What is not in doubt: it has never been approved for adults, so every adult prescription is off-label use of a compounded preparation.
The approved evidence base is paediatric. The adult evidence is a handful of small, short studies from the 1990s.
For its approved use, the 1999 BioDrugs review concluded that limited data showed once-daily sermorelin was effective in promoting growth in some prepubertal children with idiopathic growth hormone deficiency, with gains in height velocity sustained over 12 months and, in a few children, 36 months. Its effect on final adult height had not been established. The review also notes that increases in height velocity were smaller than in children given daily somatropin, recombinant growth hormone, at the same microgram-per-kilogram dose, although the recommended doses were never compared directly.
In older adults the controlled record is thin. Vittone and colleagues at Johns Hopkins (Metabolism, 1997) treated 11 healthy men aged 64 to 76 with nightly GHRH (1-29) for six weeks. Nocturnal growth hormone rose, IGF-1 did not, two of six strength measures improved, and muscle and fat measured by DEXA did not change. Khorram and colleagues (Journal of Clinical Endocrinology and Metabolism, 1997) gave 19 adults aged 55 to 71 a closely related analogue, not sermorelin itself, for 16 weeks after a placebo run-in, and reported higher growth hormone and IGF-1, with lean mass and insulin sensitivity improving in men but not women. Those are real findings and they are small, short and nearly thirty years old.
The paediatric and diagnostic literature describes sermorelin as well tolerated, with transient facial flushing and pain at the injection site as the most commonly reported adverse events, according to the 1999 review. The Vittone study reported no significant adverse effects over six weeks; the Khorram study reported transient hyperlipidaemia that resolved. None of that establishes long-term safety in adults taking a compounded preparation for years, because no study has followed adults for years. Compounded preparations are also not FDA approved products, so the FDA has not reviewed their quality or consistency.
The only doses ever on an FDA label were for children and for a diagnostic test. There has never been an approved adult dose of sermorelin.
According to the 1999 review, the recommended treatment regimen was 30 micrograms per kilogram of bodyweight once daily by subcutaneous injection at bedtime, in prepubertal children with idiopathic growth hormone deficiency, and the diagnostic use was a single intravenous dose of 1 microgram per kilogram. Those figures belong to a paediatric product that no longer exists. The adult figures found on most pages that rank for sermorelin dosage come from clinic protocols and compounding pharmacies, several of which sell the product, and none from a label or a large controlled trial. We report the label because it is the record. We do not publish a recommended dose or protocol for this or any compound.
Check whether the page separates the three things it could mean by "FDA approved". Sermorelin was approved, for children and diagnosis; it is not approved now, because no product is marketed; and it was never approved for the adult uses most pages describe. Nearly every site ranking for sermorelin dosage or benefits sells it, prescribes it, or sells a consultation leading to it, and many collapse those three statements into one. This page carries a date at the top, 25 September 2026, so you can tell when it stops being current.
Not currently. Sermorelin acetate was approved as Geref: NDA 19-863 on 28 December 1990 for diagnostic testing of pituitary growth hormone secretion, and NDA 20-443 on 26 September 1997 for idiopathic growth hormone deficiency in children with growth failure. EMD Serono discontinued both in 2008 and the approvals were withdrawn effective 18 June 2009. No approved sermorelin product is on the US market as of September 2026.
The manufacturer stopped making it. In a Federal Register notice of 4 March 2013 (78 FR 14095, docket FDA-2012-P-1071), the FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness. That determination is what allows the FDA to consider generic applications for it.
Compounding pharmacies prepare it by prescription under section 503A, relying on the "component of an FDA-approved drug" pathway and the 2013 determination. It is not on the 503A Bulks List or its interim categories, and the FDA has not published a sermorelin-specific statement on that pathway. It has never been approved for adults or for ageing, so any such use is off-label use of a compounded preparation.
The approved treatment use was in children with idiopathic growth hormone deficiency. A 1999 review in BioDrugs describes the recommended regimen as 30 micrograms per kilogram once daily by subcutaneous injection at bedtime, and the diagnostic use as a single intravenous dose of 1 microgram per kilogram. There has never been an approved adult dose. Adult figures in circulation come from clinics and compounders, not from a label.
In its approved use the review found that it increased height velocity in some prepubertal children, on limited data. In older adults, the published controlled work is small and dates from the 1990s: studies of 11 and 19 people lasting 6 and 16 weeks measured rises in growth hormone and, in one, IGF-1, with mixed effects on body composition and strength. No large trial has tested it for ageing.
In the paediatric and diagnostic literature, transient facial flushing and pain at the injection site were the most commonly reported adverse events (Prakash and Goa, BioDrugs, 1999). The small adult studies of the 1990s were too short and too small to establish long-term safety.
No. Sermorelin is a fragment of the hormone that tells the pituitary to release growth hormone; it is not growth hormone itself. It was never compared head to head with somatropin at its recommended dose, and in the children studied, increases in height velocity were smaller than with daily somatropin at the same microgram per kilogram dose.
Both act on the growth hormone-releasing hormone receptor. Tesamorelin is FDA approved and marketed today as Egrifta, but only to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. Sermorelin was approved for children and for diagnosis and is no longer marketed. Neither is approved for ageing or general weight loss.
Whatever you decide, your own numbers are the one part of this that is not contested. A baseline panel costs less than a month of most things sold in this category and it is yours to keep.
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