Sermorelin

What it is

Sermorelin is a synthetic analog of the first 29 amino acids of GHRH (GHRH 1-29) that stimulates the pituitary to release growth hormone in a pulsatile pattern.S1

Marketed as

Sermorelin is promoted for anti-aging, body composition, recovery, and sleep, often through wellness clinics and compounding channels. These are marketing claims, not established effects, and they fall outside any current approved label.S1

Regulatory status (US)

Sermorelin acetate was formerly FDA-approved as Geref; FDA has formally determined that the product was discontinued for commercial reasons, not for safety or effectiveness.S1 There is no currently marketed FDA-approved sermorelin finished drug; it is available through compounding pharmacies, which operate under state/USP oversight and are not the same as FDA approval (see caveat).S1

Around the world

Sermorelin is not a broadly licensed marketed medicine; its present availability runs mainly through compounding and off-label wellness channels rather than as an approved product.S1

Evidence

Historically, sermorelin was used in a diagnostic / growth-hormone-axis context when it was approved.S1 Its current anti-aging and recovery promotion is off-label and is not supported by an approved-label evidence base.S1

Anti-doping

As a GHRH analog / growth-hormone secretagogue, sermorelin falls under WADA S2 and is prohibited at all times in sport.S2

Safety

Because it is no longer an approved finished product, sermorelin's safety in current use rests on compounded preparations outside FDA finished-drug oversight; the general concerns for compounded GH-axis peptides apply (characterization, purity, limited modern safety data).S1

What's changing

The standing item to track is sermorelin's status within the compounding framework, and the distinction between its former approval and current compounded supply.S1