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✓ The FDA has repeatedly flagged AOD-9604 as a compound of concern. It was placed on the Category 2 list in 2023 — bulk drug substances in compounding that may present significant

Compounding was initially permitted under drug shortage provisions

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This combined approach results in improved glycemic control and substantial weight reduction, with clinical trials demonstrating HbA1c reductions of 1.9% to 2.4% and weight loss of approximately 15% to 22% of body weight at the highest doses in specific trials such as SURMOUNT-1