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2023 showed in Gordonia GONU that the relevant esterases are not constitutive but substrate-induced EstG2 is upregulated 91-fold by DEHP, EstG5 156-fold by DnOP, and the monoesterase EstG3 120-fold
This enzymatic action depletes the available intracellular pool of nicotinamide, directly limiting the synthesis of nicotinamide adenine dinucleotide (NAD+)
FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data
Signs you may need to reduce dose include persistent headaches, unusual fatigue, or injection site reactions that worsen over time
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