Sermorelin

What is sermorelin?

Sermorelin is a 29-amino-acid analog of growth hormone-releasing hormone (GHRH), described as the shortest synthetic peptide with GHRH's full biological activity [1]. Given by injection, it stimulates the anterior pituitary to release growth hormone [1]. A once-daily subcutaneous dose of 30 micrograms per kilogram at bedtime was effective in some prepubertal children with idiopathic GH deficiency in the studies reviewed [1].

Was sermorelin ever FDA-approved?

Yes. Geref (sermorelin acetate) held two approved new drug applications: one from December 28, 1990, for evaluating the pituitary's ability to secrete growth hormone, and a second from September 26, 1997, approved for idiopathic growth hormone deficiency in children with growth failure [2]. The manufacturer, EMD Serono, told FDA in 2008 it was discontinuing both products and asked FDA to withdraw the approvals; FDA did so effective June 18, 2009, and determined the withdrawal was not for reasons of safety or effectiveness [2].

Is compounded sermorelin legal today?

That question isn't spelled out. Sermorelin does not appear in FDA's Category 1, 2 or 3 nominated-substances list published May 14, 2026 [3], so it is neither flagged as a safety risk nor formally addressed through 503A compounding. FDA's determination allows generic sermorelin applications, since the withdrawal wasn't for safety, but whether a specific compounded product meets section 503A's other conditions is a decision for the pharmacy and its counsel, not something this page can settle.