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AOD-9604 (free base) or AOD-9604 acetate on the 503A Bulks List, and AOD-9604 is currently listed as Nominated but Withdrawn from FDA Category 2

After centrifugation at 16,000 g for 5 min, the resulting supernatant was used for processing

Each injectable IV product will have the osmolarity listed on the label located on the vial

Their therapeutic potential in managing oxidative stress-related male infertility underscores the importance of targeting mitochondrial function to improve sperm quality and fertilization outcomes