Verified product status
AOD-9604 Development and Compounding Status
FDA’s December 2024 evaluation proposed not adding AOD-9604 free base or acetate to the 503A Bulks List, citing characterization, effectiveness and safety limitations. That compounding-list evaluation is not a product approval review and should not be rewritten as one.
Dated verification
What the reviewed sources establish
A regulatory proposal, advisory recommendation, clinical-development stage and marketing approval are kept as separate findings.
No FDA-approved AOD-9604 finished drug identified in reviewed sources
FDA evaluation
FDA proposed not including AOD-9604 free base or acetate
December 2024 PCAC briefing
FDA review described limited evidence and studies that generally failed to show weight-reduction benefit versus placebo
FDA briefing review; not a new site efficacy analysis
Status timeline
Keep the date attached to the claim.
Later events do not retroactively change what an earlier source established. This timeline records the source context used for the current wording.
AOD-9604 underwent clinical investigation; development history does not equal approval.
FDA presented its 503A evaluation and proposed not adding the reviewed AOD-9604 forms.
Status rechecked; no FDA-approved finished product is claimed.
Entity boundary
The name is not the approval.
Historical clinical investigation, a compounding nomination and catalog supply are different regulatory categories. None makes a research material an approved obesity medicine.
Research and regulatory information only. No clinical-use or dosing guidance.Primary and technical sources
Records used for this guide
Sources are linked directly so the wording, date and scope can be checked independently.
- 01Source record
FDA Evaluation of AOD-9604-Related Bulk Drug Substances
U.S. FDA. December 4, 2024 Pharmacy Compounding Advisory Committee briefing document.
- 02Source record
Certain Bulk Drug Substances That May Present Significant Safety Risks
U.S. FDA. Current compounding safety-information page.
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