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The GRAS designation has created regulatory ambiguity: while AOD-9604 supplements are legally available, their marketing often implies therapeutic benefits that remain unproven

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Without rigorous testing and process controls, a compounded drug could be sub-potent (containing too little API to be effective) or super-potent (containing a dangerously high dose)

Morning or evening timing produces similar results provided consistency remains daily

It was first FDA-approved in 2022, also as a treatment for controlling blood sugar in people with type 2 diabetes