Pediatric growth hormone deficiency
Sermorelin was approved twice in the US, both times as Geref: as a diagnostic product in 1990, for testing whether the…
The approved past: sermorelin’s strongest, and oldest, direct evidence
Sermorelin was approved twice in the US, both times as Geref: as a diagnostic product in 1990, for testing whether the pituitary can secrete growth hormone, and as a treatment in 1997, for idiopathic growth hormone deficiency in children with growth failure. The treatment side is where its trial evidence is strongest: the pivotal open-label trial showed children growing faster on nightly sermorelin than they had before treatment. Small adult trials exist too, and the adult-use unit reads them closely, but no approval ever covered adult treatment.
This unit covers what pediatric GHD is, the Geref trial that anchors the evidence, the approval and the 2008 discontinuation that ended it, and how sermorelin compared with recombinant GH.