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FDA reported that between June 2023 and August 2025, the company found objectionable microorganisms, specifically Bacillus cereus , in finished drug product samples on nine separate occasions

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Frontiers in Cell and Developmental Biology , 9, 822805.

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Importantly, the study confirmed that AOD-9604 displayed a very good safety and tolerability profile indistinguishable from placebo, with no treatment-related serious adverse events or study withdrawals occurring

Regenerative and nootropic industries have touted its benefits