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AOD-9604 received FDA GRAS (Generally Recognized As Safe) status as a food ingredient in 2007, but this is not drug approval

The FDA also noted major evidence gaps for subcutaneous, topical, and nasal exposure, so the trial record does not establish safety for those routes

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The use of NNMT inhibitors as a potential obesity treatment has been investigated preclinically 8,9,13 , and observational clinical data suggests that increased NNMT expression and activity correlate with increased incidence of Type 2 diabetes (T2D) and risk of obesity, respectively 10,11

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