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Sermorelin's FDA Journey: Approved, Discontinued, and Compounded Sermorelin acetate (Geref) was FDA-approved in 1997 for pediatric GHD 1 and in 1990 for diagnostic use.26 The manufacturer discontinued Geref in 2008 due to "manufacturing difficulties," not safety or efficacy concerns.12 In 2013, the FDA confirmed it wasn't withdrawn for safety/effectiveness, allowing for potential generic approvals.12 Currently, Sermorelin is primarily available as a compounded medication 3, which is permitted but not individually FDA-approved like mass-produced drugs.22 5.2

Abbreviations ROS: Reactive oxygen species RNS: Reactive nitrogen species SOD: Superoxide dismutase GPx: Glutathione peroxidase GSH: Glutathione GRd: Glutathione reductase CAT: Catalase H 2 O 2 : Hydrogen peroxide OH : Hydroxyl radical 1 O 2 : Singlet oxygen O 2 : Superoxide anion O 2 : Oxygen radical RO : Alkoxy radical ROO : Peroxyl radicals NO : Nitric oxide NO 2 : Nitrogen dioxide LOO : Peroxyl radical HOCl: Hypochlorous acid HNO 2 : Nitrous acid NO : Nitroxyl anion NO + : Nitrosyl cation N 2 O 4 : Dinitrogen tetroxide N 2 O 3 : Dinitrogen trioxide NO 2 + : Nitronium cation ONOOH: Peroxynitrite HO 2 : Hydroperoxyl radical NADPH: Nicotinamide adenine dinucleotide phosphate XO: Xanthine oxidase LO: Lipoxygenase CYP450: Cytochrome P450 MPO: Myeloperoxidase Fe: Iron Cu: Copper DNA: Deoxyribonucleic acid RNA: Ribonucleic acid O-LDL: Oxidised low-density lipids NF-B: Nuclear Factor Kappa B MAPK: Mitogen-activated Protein Kinase EGF: Epithelial growth factor FALS: Familial amyotrophic lateral sclerosis SeC: Seleno-cysteine AMK: N1-acetyl-5-methoxykynuramine AFMK: Cyclic 3-hydroxymelatonin, N1-acetyl-N2-formyl-5-methoxykynuramine MLT: Melatonin UA: Uric acid CNS: Central nervous system AsA: Ascorbic acid DHA: Dehydroascorbate ALA: - Lipoic acid DHLA: Dihydrolipoic acid BCO1: -Carotene-15, 15'-oxygenase ALDH1: Aldehyde dehydrogenase 1 PUFA: Polyunsaturated fatty acid WHO: World Health Organisation NFT: Neurofibrillary tangled AD: Alzheimers disease SNpc: Substantia nigra pars GDM: Gestational diabetes mellitus ADA: American Diabetes Association TMDR: Transition metal-dependent reaction LDL: Low-density lipoprotein AGEs: Advanced glycation end-products RA: Rheumatoid arthritis References de Almeida AJPO, de Oliveira JCPL, da Silva Pontes LV, de Souza Jnior JF, Gonalves TAF, Dantas SH, de Almeida Feitosa MS, Silva AO, de Medeiros IA

Not suitable for children under 15 years of age or while pregnant or breastfeeding

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These effects are thought to occur through activation of cholinergic neurons