AOD-9604 is widely framed as a fat-loss fragment of human growth hormone without the full hormone's broader effects.
Human safety trials exist, but a sponsor-linked summary does not establish meaningful obesity benefit, and PCAC did not recommend either reviewed form.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
4 names in this peptide family.
AOD-9604 free base and acetate remain distinct nominated bulk drug substances. Evidence from the studied oral and intravenous products is not silently transferred to a differently formulated compounded injection.
4 evidence questions.
Human benefitMultiple human trialsDoes AOD-9604 have established human clinical benefit for obesity?
FDA approvalNo FDA approval identifiedIs AOD-9604 FDA approved?
503A statusRegulatory recordIs AOD-9604 on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled AOD-9604 automatically interchangeable?
See every AOD-9604 evidence question →Open the machine-readable record ↗PCAC did not recommend AOD-9604 for the 503A Bulks List
The committee voted 0–12 against recommending the reviewed free-base and acetate forms.
FDA received an unfavorable expert recommendation.
The vote was non-binding, was not an FDA approval decision, and did not itself create a final legal change.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
PCAC did not recommend AOD-9604 for the 503A Bulks List
The committee voted 0–12 against recommending the reviewed free-base and acetate forms.
Read the source ↗FDA completed its scientific briefing
FDA evaluated AOD-9604 free base and acetate for compounded products proposed for obesity.
Read the source ↗AOD-9604 entered FDA's 503A nomination record
AOD-9604-related substances were nominated for possible inclusion on the 503A Bulks List; the nominations were later withdrawn and FDA continued the review on its own initiative.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
A 2013 sponsor-linked article summarized six trials in 893 adults. It focused on safety and tolerability; it does not establish a clinically meaningful obesity benefit, and FDA's later review identified remaining evidence and product-quality gaps.
Read the FDA review ↗AOD-9604 reduced weight gain and fat mass in obese mice. Animal findings do not establish weight-loss benefit or safety in people.
Read the study on PubMed ↗Important unknowns.
- A published sponsor-linked summary describes six randomized, double-blind, placebo-controlled trials involving 893 adults, with safety as its main focus.
- FDA identified formulation, impurity, immunogenicity, and broader safety uncertainties that the published trial summary does not resolve.
- Evidence from oral or intravenous study products should not be transferred automatically to a compounded injectable product.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
3 dated changes. 0 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.