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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AOD-9604 (free base) or AOD-9604 acetate on the 503A Bulks List, and AOD-9604 is currently listed as Nominated but Withdrawn from FDA Category 2

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No statistically significant mean differences in behavior tests or in glutathione status were identified between active and placebo groups. However, detailed data analysis suggests that methyl B12 may alleviate symptoms of autism in a subgroup of children