The other submission commented on the consideration to place AOD-9604 in Appendix D. The submission supported listing in Schedule 4, but raised concerns that listing the substance in Appendix D would limit any future development work, including clinical trials that are currently being conducted on the substance. The submitter notes that there are currently 5 clinical trials notified to the TGA using this substance , with these approved clinical trials going ahead on the basis that the substance is safe for human use. Inclusion in Appendix D may place unnecessary burden on those conducting these clinical trials.
Growth hormone-releasing peptide 6 (GHRP-6) (developmental code name SKF-110679), also known as growth hormone-releasing hexapeptide, is one of several synthetic met-enkephalin analogues that include unnatural D-amino acids, were developed for their growth hormone-releasing activity and are called growth hormone secretagogues. They lack opioid activity but are potent stimulators of growth hormone (GH) release. These secretagogues are distinct from growth hormone releasing hormone (GHRH) in that they share no sequence relation and derive their function through activation of a completely different receptor. This receptor was originally called the growth hormone secretagogue receptor (GHSR), but due to subsequent discoveries, the hormone ghrelin is now considered the receptor's natural endogenous ligand, and it has been renamed as the ghrelin receptor. Therefore, these GHSR agonists act as synthetic ghrelin mimetics.
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