History and Devel­op­ment

Sermorelin's story starts with an unusual medical case, runs through two decades as a licensed product and ends, for now, with a quiet withdrawal.

A Hormone Found in a Tumour

For years scientists suspected that the brain made a hormone that released growth hormone, but it was present in such tiny amounts that nobody could isolate it. The breakthrough came in 1982 from tumours of the pancreas that had caused acromegaly, a condition of excess growth hormone. Two teams at the Salk Institute in California, one led by Roger Guillemin and the other by Wylie Vale and Jean Rivier, extracted the releasing hormone from these tumours and worked out its structure. It proved to be the same hormone the brain produces.

Cutting It Down to 29

Further work showed that the first 29 amino acids carried the full biological effect. This shorter version was easier and cheaper to make, and it became the basis of a medicine. The Swiss company Serono developed it under the name Geref.

Approval in the United States

In December 1990 the US Food and Drug Administration approved Geref Diagnostic, used in hospitals to check whether the pituitary could release growth hormone. In September 1997 a second version was approved to treat children with idiopathic growth hormone deficiency and poor growth, meaning cases where no structural cause could be found.

Withdrawal

In 2008 EMD Serono, as the company was then called in the US, told doctors it was stopping Geref Diagnostic because the active ingredient was no longer being manufactured. The treatment version followed later that year, and the FDA formally withdrew both approvals in June 2009. Children who needed treatment were moved to growth hormone injections.

What Came After

In 2013, answering a citizen petition, the FDA confirmed that Geref had not been withdrawn for reasons of safety or effectiveness. This ruling matters in the US, where compounding pharmacies have continued to prepare sermorelin on prescription, often for adults who want to raise their growth hormone levels. Anti-doping laboratories have meanwhile developed tests to catch it in urine.