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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in 2008 due to "manufacturing difficulties," not safety or efficacy concerns.12 In 2013, the FDA confirmed it wasn't withdrawn for safety/effectiveness, allowing for potential generic approvals.12 Currently, Sermorelin is primarily available as a compounded medication 3, which is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
We used n = 79 per group to allow for strength of statistical outcomes and each in vivo study was replicated three times
Provider Disclaimer Clinical Judgment and Individualized Care This protocol is intended as a general guideline for qualified healthcare providers
GLP-1s can greatly slow the progression of type 2 diabetes when used early, before beta-cell mass and function are lost, helping to preserve or potentially restore these cells
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