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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in 2008 due to "manufacturing difficulties," not safety or efficacy concerns.12 In 2013, the FDA confirmed it wasn't withdrawn for safety/effectiveness, allowing for potential generic approvals.12 Currently, Sermorelin is primarily available as a compounded medication 3, which is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

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J Sci Med Sport 20:e36e37 Fukuta S, Oyama M, Kavalkovich K, Fu F, Niyibizi C (1998) Identification of types II, IX and X collagens at the insertion site of the bovine Achilles tendon

Medical supervision requirement: All AOD-9604 therapy requires comprehensive physician oversight including baseline health assessment and laboratory work, informed consent regarding research-purposes-only status, regular monitoring of body composition and metabolic markers, dose adjustments based on individual response, and integration with comprehensive health optimization strategies