AI illustration · not actual product photoDetails from the source.
This catalogue entry records AOD9604, 2 mg × 10 vials (SKU 2AD), using the supplied source listing. The cited dossier describes: Research has focused mainly on fat metabolism and obesity. AOD-9604 was evaluated as an investigational obesity candidate; FDA-reviewed clinical evidence did not demonstrate significant benefit in the larger 24-week study, and development for obesity was terminated. It also distinguishes available human evidence, limitations, safety concerns, and regulatory context. It does not verify this supplier-specific item’s identity, formulation, lot quality, or approval. This is not medical advice, a treatment recommendation, or authorization for human use.
- Catalogue code
- 2AD
- Source specification
- 2mg*10vials
- Source document
- PriceList(1).pdf, page 3
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
The literature-defined AOD-9604 molecule is a synthetic 16-amino-acid peptide fragment of human growth hormone, not full-length growth hormone. The exact chemical identity and form of the catalogue vials are not verified from the supplier label alone.
Biological mechanism
The mechanism is not established. Animal studies report increased lipolysis and reduced lipogenesis. Mouse work suggests beta-3 adrenergic receptor expression may contribute, but does not establish direct receptor mediation or a human mechanism. FDA describes the molecular target and mechanism as unknown.
Research focus
Research has focused mainly on fat metabolism and obesity. AOD-9604 was evaluated as an investigational obesity candidate; FDA-reviewed clinical evidence did not demonstrate significant benefit in the larger 24-week study, and development for obesity was terminated.
Potential applications in the evidence
Weight reduction in adults with obesity was investigated. The available evidence does not establish a clinical application or reliable benefit. Animal findings should not be presented as human effects.
Human evidence
Early small or sparsely reported studies suggested a possible weight-loss signal, but the FDA review noted limited methods/results and unclear clinical meaning. In the OPTIONS study, 502 adults were treated (536 enrolled) for 24 weeks; AOD-9604 did not produce a statistically significant weight-loss difference versus placebo. FDA found no human pharmacokinetic or pharmacodynamic studies and no human evidence for the subcutaneous or topical routes it reviewed. These findings do not establish efficacy or safety for the catalogue vials.
Known and potential effects
Limited oral human reports listed headache, diarrhea, flatulence, increased appetite, and nausea. Serious events reported included diarrhea and chest tightness considered possibly related by study authors. Several cancer diagnoses were reported but considered unrelated by study authors; available data do not establish causation. This is not a complete or validated safety profile.
Safety and contraindications
FDA identifies potential immunogenicity concerns, especially for injectable products, related to aggregation and peptide-related impurities, as well as gaps in identity, characterization, and safety data. FDA states that serious adverse events may be associated with AOD-9604, although causality is unclear. Human safety data are limited and do not establish long-term or route-specific safety. No reliable product-specific contraindication or interaction list can be verified. The exact catalogue vial's composition, formulation, quality, and sterility are unknown from the supplied sources.
U.S. FDA / regulatory status
No FDA-approved AOD-9604 drug product or branded formulation was verified in the FDA sources reviewed. FDA proposed against adding AOD-9604 free base or acetate to the 503A Bulks List and currently lists AOD-9604 under Category 2 for significant safety risks. Category 2 is a compounding-policy status, not FDA approval and not a finding that these exact supplier vials are compounded. The source material does not identify their manufacturer, formulation, jurisdiction, lot, or approval status; approval of another formulation or product would not transfer to these vials.
Evidence limitations
The molecular mechanism is unresolved; animal results may not translate to humans. Human studies are short or incompletely reported, the larger obesity study failed to show significant benefit, and route-specific and long-term safety data are lacking. FDA notes limitations in study details and adverse-event reporting. Some safety summaries were sponsor-funded. The catalogue name does not establish that the vial has the studied sequence or chemical form.
Supporting sources
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration · Official regulator safety information. Supports: FDA's current AOD-9604 Category 2 entry, potential immunogenicity and peptide-impurity concerns, limited safety information, and serious adverse events with unclear causality.
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act U.S. Food and Drug Administration · Official regulator policy page. Supports: Explains Category 2 as a compounding-policy category for substances presenting safety risks and distinguishes it from approval.
- Pharmacy Compounding Advisory Committee: AOD-9604-Related Bulk Drug Substances U.S. Food and Drug Administration · Official regulator advisory committee presentation. Supports: FDA review of molecule identity, free-base/acetate ambiguity, proposed formulations and characterization gaps, animal mechanism, human efficacy and adverse events, and the recommendation against adding AOD-9604 to the 503A Bulks List.
- The effects of human GH and its lipolytic fragment on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice Endocrinology / PubMed, National Library of Medicine · Primary preclinical animal study. Supports: Mouse findings on body weight, lipid metabolism, and beta-3 adrenergic receptor expression; supports clear separation of animal findings from human evidence.
- Obesity Pharmacotherapy: Current Perspectives and Future Directions Current Cardiology Reviews / PubMed Central · Peer-reviewed review. Supports: Summarizes the AOD-9604 obesity development program, early human signal, and termination after the larger trial failed to demonstrate efficacy.
- Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health Journal of Endocrinology and Metabolism / Elmer Press · Peer-reviewed safety and metabolism review/article. Supports: Describes the literature-defined peptide fragment, preclinical metabolic effects, unresolved mechanism, and sponsor-linked clinical safety summaries and limitations.