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| Agent | FDA Approval | Mean Weight Loss (RCT) | Route | |---|---|---|---| | Semaglutide 2.4 mg (Wegovy) | Yes (2021) | 14.9% at 68 weeks (STEP-1, N=1,961) [9] | Subcutaneous weekly | | Tirzepatide 15 mg (Zepbound) | Yes (2023) | 20.9% at 72 weeks (SURMOUNT-1, N=2,539) [11] | Subcutaneous weekly | | AOD-9604 1 mg oral | No | ~2.8 kg at 12 weeks (Phase IIb, N=300 approx.) [1] | Oral (not currently compounded) | The weight-loss magnitude from the single Phase IIb AOD-9604 trial is substantially smaller than what STEP-1 (semaglutide) and SURMOUNT-1 (tirzepatide) demonstrated in larger, longer trials
Why this is legal in 2026 Compounded semaglutide is dispensed under Section 503A of the Federal Food, Drug, and Cosmetic Act, which authorizes a state-licensed pharmacy to compound a drug for an identified individual patient with documented medical need
However, this pathway may not explain everything that was observed
Inositol Inositol breaks down fats to keep them from accumulating
Storage and handling Unopened lyophilized vials hold up well under dry ambient storage
Trends Endocrinol
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