What isAOD-9604FDA Status, Evidence and Risks (2026)

What AOD-9604 is

AOD-9604 is a synthetic piece of human growth hormone. It copies the tail end of the molecule, amino acids 177 to 191, with one extra amino acid (tyrosine) added ³.

It was developed by an Australian company, Metabolic Pharmaceuticals, and first patented in the late 1990s ³. The developer described it as carrying growth hormone's fat-reducing activity ⁴. Its trials did not show that in people.

FDA reviewed two forms, the free base and the acetate salt ³. Online sellers do not agree on what they are selling. FDA found public CAS numbers and structures that do not match across suppliers ³.

Where FDA stands

1. Sept 2024: FDA took AOD-9604 off Category 2 after its nomination was withdrawn ^1,5.
2. Dec 4, 2024: FDA reviewed it for the 503A bulks list for obesity. Nominations for osteoporosis and osteoarthritis lacked enough information to review ³. Staff said the evaluation criteria "weigh against" both forms ³.
3. Same day: the advisory committee voted 0 yes, 12 no, with no abstentions ².
4. Today: not on Category 2, not on the 503A bulks list ⁶, not approved by FDA for any use.

Coming off Category 2 approved nothing. It happened because the nominator withdrew. Are peptides legal? explains the categories.

Not in the HHS policy. On Oct 28, 2026, HHS filed an interim enforcement discretion policy for compounding six peptides: BPC-157, TB-500, MOTS-c, epitalon, semax and KPV ⁷. AOD-9604 is not one of them, so its status above stands, as of Oct 29, 2026. The FDA Peptide Tracker logs every change.

Outside the US, Australia added AOD-9604 to its poisons standard as a performance and image enhancing drug, and it is on the World Anti-Doping Agency's prohibited list ³.

What the research shows

Six randomized, double-blind, placebo-controlled trials ran between 2001 and 2006, with 893 people in total ⁴. All six were funded by the developer, and the authors of the safety paper worked for or consulted for it ⁴.

On Feb 21, 2007, the company ended development for obesity ³. It said results did not support "commercial viability," and that the difference from placebo was too low to reach statistical significance ³.

FDA concluded that "there is a lack of evidence to support the effectiveness of AOD-9604" for obesity ³.

What is missing:

• No human data for injection under the skin, the way it is usually sold, or for skin creams ³. The trials used oral and IV dosing.
• No studies listed on ClinicalTrials.gov ³.
• No clinical practice guideline mentions it ³.

Side effects and FDA's concerns

FDA's stated concerns, from its Category 2 page ¹:

• Immune reactions. Possible significant immunogenicity for certain routes.
• Thin data. No, or only limited, safety information.
• Serious events. "FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear."

What the trials reported:

• The developer's safety paper calls its safety profile "indistinguishable from placebo" and reports no serious adverse events related to the drug ⁴.
• The same paper describes serious adverse events in 5 people in the 12-week trial and 18 in the 24-week trial, which the authors judged unrelated to the drug ⁴.
• In one early trial, one person had a severe "feeling of chest tightness," possibly drug-related ³.
• In one early trial, headache and fatigue were the most common events, spread similarly across drug and placebo ³.

From FDA's animal review ³:

• Bone: dose-related changes in rats in osteocalcin, a bone marker, which could signal harm to bone.
• Liver: changes in monkey liver cells that rose with dose and may signal liver injury.
• DNA: genetic toxicity tests gave mixed results.
• FDA called the animal studies "too limited in scope to inform safety considerations."

Quality. FDA does not consider either form well characterized. Impurity data are very limited, and some certificates FDA saw did not test for endotoxins or microbes ³.

Why it's sold online anyway

No outsourcing facility reported compounding AOD-9604 from 2017 to 2023, yet FDA found clinics and med spas marketing it ³. Other products carry "research use only" labels, the seller's own statement that the product is not for people.

Those products skip a prescriber who reviews your health history and a licensed pharmacy compounding for one patient. More: Prescription vs Research Peptides. For other Shelf 1 peptides, see CJC-1295, also voted down in Dec 2024, and ipamorelin.

Asked a lot.

The sources.

1. FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of Apr 22, 2026). Read it
2. FDA. Pharmacy Compounding Advisory Committee, Dec 4, 2024, voting results. Read it
3. FDA. Pharmacy Compounding Advisory Committee, Dec 4, 2024, briefing document: AOD-9604 related bulk drug substances. Read it
4. Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab. 2013;3(1-2):7-15. Read it
5. Reed Smith. FDA removes certain peptide bulk drug substances from Category 2 (2024). Read it
6. FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (content current as of May 14, 2026). Read it
7. HHS. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496, FR Doc 2026-22192 (filed for public inspection Oct 28, 2026; scheduled to publish in the Federal Register Oct 30, 2026). Read it