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Sermorelin FDA approval history begins in 1997 when Geref (sermorelin acetate for injection) was approved for treatment of idiopathic growth hormone deficiency in children. Understanding this sermorelin FDA approval history provides important context for researchers studying GHRH analogues today. For primary records, see FDA NDA database record for Geref and Walker et al. sermorelin pharmacology (PubMed).
Sermorelin FDA Approval History: Geref Timeline and Discontinuation
Sermorelin was an approved drug, and the correction matters
Search for sermorelin and you will read, almost universally, that it is not FDA approved. That is incomplete to the point of being wrong, and the accurate version is more interesting.
Sermorelin acetate was approved by the FDA as GEREF. NDA 19-863 was approved on 28 December 1990 for the 0.05 mg ampoule presentation, and NDA 20-443 on 26 September 1997 for the 0.5 mg and 1.0 mg vials. The holder was EMD Serono.
Both were discontinued by the manufacturer in 2008, and FDA formally withdrew approval effective 18 June 2009.
The detail that changes the meaning
When FDA withdraws a product it makes a determination about why. In the Federal Register notice of 4 March 2013, FDA determined that the Geref products “were not withdrawn for reasons of safety or effectiveness.”
That determination is not a formality. It exists specifically so that generic versions can be approved through the abbreviated pathway — which is only possible where the original was pulled for commercial rather than safety reasons.
So sermorelin is not an unapproved compound of unknown safety. It is a formerly approved drug that a manufacturer stopped making because it was not commercially worthwhile.
| Compound | Regulatory history |
|---|---|
| Sermorelin | Approved 1990 and 1997; withdrawn 2009, explicitly not for safety or efficacy |
| Tesamorelin | Approved and still marketed in the US; approved in Canada 2014, both DINs since discontinued |
| CJC-1295 | Never approved anywhere; Phase II halted in 2006 |
| Ipamorelin | Never approved; placed on FDA’s Category 2 bulk substances list in 2023 |
One more distinction worth noting
Health Canada’s April 2026 advisory RA-81874 names fourteen peptides — BPC-157, CJC-1295, DSIP, epitalon, GHK-Cu, hCG, ipamorelin, KPV, melanotan I and II, MOTS-c, NAD+, SS-31, TB-500 and Retatrutide research peptide Canada.
Sermorelin is not among them. That is a factual observation about which substances the advisory lists, not a claim that sermorelin is authorised in Canada — it has no DIN and is not an approved product here. But it is a real difference from the compounds that are named, and it is the kind of distinction that gets flattened when everything is lumped together as “unapproved peptides”.
Anti-doping status is unchanged
Sermorelin is named individually on the WADA 2026 Prohibited List under S2.2.4, prohibited at all times as a non-Specified Substance. Former approval status has no bearing on that.
Primary sources
- FDA orphan-drug designation and approval record for sermorelin acetate (Geref).
- FDA Geref approval package.
- FDA determination concerning the discontinuation of Geref.
- Health Canada Drug Product Database for current Canadian authorization records.
- World Anti-Doping Agency 2026 Prohibited List.
Related Anglo Peptides resources
For a molecular and experimental comparison, see Sermorelin vs CJC-1295. Product identity and current lot documentation are listed on the Sermorelin research product page.
Research use only. This article is educational and does not provide medical advice. Research-grade Sermorelin sold by Anglo Peptides is not intended for human or veterinary consumption.
Related Peptide Research Articles
Continue reading: Sermorelin vs CJC-1295 Canada, CJC-1295 DAC vs No DAC, Ipamorelin Half-Life and Onset.
