Is Sermorelin FDA-Approved? Its FDA and 503A Status in 2026

Sermorelin is not an FDA-approved drug today, though it once was. FDA approved sermorelin acetate under the brand name Geref, held by EMD Serono: first on December 28, 1990 (NDA 19-863), and again on September 26, 1997 (NDA 20-443). Both products are listed as discontinued in Drugs@FDA, and no other sermorelin application appears there.

The discontinuation is the part most often misreported. EMD Serono notified FDA in 2008 that it was stopping both products. In March 2013, FDA published a determination that Geref was not withdrawn from sale for reasons of safety or effectiveness. That is a narrow legal finding. It allows FDA to approve generic versions that reference Geref, if all other requirements are met. It is not a new approval, and no generic has been approved since.

Sermorelin has an approval history that CJC-1295 and ipamorelin lack. FDA approved the 0.05 mg Geref ampule in December 1990 to evaluate whether the pituitary can secrete growth hormone. In September 1997 it approved the 0.5 mg and 1.0 mg vials to treat idiopathic growth hormone deficiency in children with growth failure. Those were the approved uses, and the only ones.

EMD Serono told FDA in letters dated July 11 and December 2, 2008 that it was discontinuing the products. Five years later, FDA concluded in the Federal Register that they had not been withdrawn for reasons of safety or effectiveness. The notice records that finding but gives no commercial reason, so this page does not offer one.

Sermorelin does not appear on FDA’s 503A category list, the list FDA uses while it reviews ingredients nominated for pharmacy compounding. That list is still dated May 14, 2026. Absence from it means something different for sermorelin than for a peptide like CJC-1295 or ipamorelin. Sermorelin was the active ingredient of an FDA-approved drug, and federal compounding law treats ingredients of approved drugs differently from ingredients that were never approved.

How far that history carries for each formulation is not definitively settled, and this page does not settle it. In practice, sermorelin is generally treated as compoundable because of its prior approval. Your physician should confirm the current legal pathway when care begins.

Sermorelin and tesamorelin both mimic growth-hormone-releasing hormone, and WADA files both under S2.2.4 as GHRH analogues. Their regulatory paths split. Tesamorelin, as Egrifta, is FDA-approved and still marketed for one narrow indication. Sermorelin’s approved product no longer exists.

So "a sermorelin drug was FDA-approved" is accurate history, and "sermorelin is FDA-approved" is not accurate today. Neither approval ever covered adult growth-hormone optimization or anti-aging use.