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Sermorelin
It was a genuinely approved medicine for a specific pediatric use — withdrawn from the US market in 2008 for commercial reasons, not safety ones. The adult "anti-aging" use it's sold for today was never what it was approved or tested for.
In brief
Should you care? Yes, if you've heard it pitched as a gentler, more "natural" alternative to growth hormone itself — it has a real approval history, but not for the use it's currently marketed for.The short version
- Genuinely approved once, for growth failure in children with growth hormone deficiency.
- Withdrawn in 2008 — FDA's own record confirms this was commercial, not a safety finding.
- No dedicated trial supports the adult wellness/anti-aging use it's sold for now.
What it is
Sermorelin acetate is the synthetic form of the first 29 amino acids of human growth hormone-releasing hormone (GHRH) — the fragment that retains full biological activity.
Its real approval history
FDA approved a sermorelin injection for diagnostic use in 1990, then Geref (0.5mg and 1.0mg) in 1997 for idiopathic growth hormone deficiency in children with growth failure. Manufacturer EMD Serono voluntarily withdrew Geref from the US market in 2008. FDA's own Federal Register notice states plainly that this withdrawal was not for reasons of safety or effectiveness — the Agency continued listing it as discontinued for commercial reasons only, meaning generic versions could still, in principle, reference it (Federal Register 2013-04827, 4 March 2013).
What it's sold for today
No longer available as an approved branded product in the US, sermorelin is sold today mainly through compounding pharmacies for adult "anti-aging," recovery and fat-loss uses. None of these uses were the subject of its original pediatric-GHD trials, and we did not locate a dedicated trial testing sermorelin for any of them directly — the marketed use is extrapolated from a different population and a different endpoint than what was actually studied.
A real approval doesn't transfer to a different use
This is a useful example of a pattern worth watching for generally: a genuinely approved drug, with real trial data, being sold today for a use that data never tested.
Doping status
Sermorelin is listed under the World Anti-Doping Agency's S2 category (GHRH and analogues), prohibited both in and out of competition.
References
- Federal Register, "Determination That GEREF (Sermorelin Acetate) Injection... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness," 2013-04827 (4 March 2013).