As of June 2026, the FDA's December 2024 Pharmacy Compounding Advisory Committee evaluation concluded that the criteria weighed against placing AOD-9604 (free base) or AOD-9604 acetate on the 503A Bulks List, and AOD-9604 is currently listed as Nominated but Withdrawn from FDA Category 2
The evidence for sublingual being substantially better than oral is mixed, but there is enough clinical experience supporting it in post-bypass patients that I think it is a sensible choice for that group

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How This Product Fits Into Multi-Compound Research Programs Modern laboratories rarely rely on a single compound
Vitamin B12 deficiency is a possibility if you're not having enough of it from the foods