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AOD-9604 Dosage: Clinics Sell 300 Micrograms. The Trials Ran on Milligrams.

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The AOD-9604 dosage printed across clinic pages is a subcutaneous shot of 200 to 500 micrograms a day. No human trial of that route at that amount appears in the published record, and the FDA’s reviewers wrote in December 2024 that they could not find human exposure data for subcutaneous AOD-9604 at all. The six sponsored human trials ran between 2001 and 2006 in Australia, delivered the peptide by intravenous infusion at 25 to 400 micrograms per kilogram or by mouth at 0.25 to 54 milligrams a day, and ended with a 24-week study that missed its weight loss endpoint.

No established AOD-9604 dosage exists. The peptide is not an approved drug, the injection protocol sold online has no human study behind it, and the one long trial failed on its primary measure.

AOD-9604 is a sixteen amino acid fragment of human growth hormone, with a tyrosine added for stability, carrying the fat mobilizing region of the protein without the growth promoting region. FDA’s compounding memo of December 4, 2024 calls it a hexadecapeptide, records that no USP monograph exists for it, and records that it is not a component of any approved drug.

AOD-9604 Dosage – What FDA Said About The Injection Route

A dose sold to patients should rest on a study of that dose by that route. For the injected form, the briefing document FDA prepared for its Pharmacy Compounding Advisory Committee says otherwise:

“The nominations did not include, and we did not identify human exposure data on this substance administered via two of the proposed routes of administration (ROAs), SC or topical.”

The nominating pharmacies asked for 1,200 micrograms per milliliter for subcutaneous injection, 600 micrograms in a capsule, and 600 micrograms per gram in a cream. FDA evaluated the substance for obesity, found no monograph and no approved drug containing it, and proposed not adding it to the list of bulk substances that compounders may use. The written concern sits on the agency’s page for substances that may present significant safety risks:

“Compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has identified no, or only limited, safety-related information. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.”

That page carried a content date of April 22, 2026 when we read it on October 29, 2026. The memo adds a detail worth holding onto. FDA’s reviewers describe clinics marketing the peptide as a 600 microgram per milliliter vial, a 1 milligram capsule, and a 250 microgram oral dissolving tablet. The smallest number in that list arrives by mouth.

AOD-9604 Dosage In The Six Trials – Micrograms Per Kilogram, Milligrams By Mouth

The human record comes from one paper: Stier, Vos and Kenley in the Journal of Endocrinology and Metabolism, 2013, summarizing six randomized, double-blind, placebo-controlled trials run between 2001 and 2006 at Australian hospitals, with 893 adults across the set.

The two early studies used an intravenous infusion: fifteen healthy men at single doses from 25 to 400 micrograms per kilogram, and 23 men with a body mass index above 35 at 25, 50 or 100 micrograms per kilogram.

The later four used capsules and tablets: seventeen men at single oral doses of 9, 27 or 54 milligrams, thirty-six men at the same amounts daily for a week, then 300 adults at 1, 5, 10, 20 or 30 milligrams daily for twelve weeks and 502 adults at 0.25, 0.5 or 1 milligram daily for 24 weeks.

Six trials, and not one gave AOD-9604 as a subcutaneous injection. Not one tested a 300 microgram dose. The route clinics sell has no trial arm in that set, which matches the FDA sentence above.

The paper’s authors were employees or consultants of Metabolic Pharmaceuticals, the Australian company that funded the trials and held the compound, a disclosure FDA records in a footnote.

What The Trials Showed – A Safety Paper Without A Weight Result

Stier and colleagues wrote a safety paper. Their endpoints were adverse events, serum IGF-1, glucose tolerance and antibodies, and on those measures the peptide came out clean: mean IGF-1 moved 1.76 nmol/L after twelve weeks and 1.24 nmol/L after 24 weeks, with p values of 0.50844 and 0.75754 against placebo, no anti-AOD-9604 antibodies turned up, and no participant withdrew because of the drug.

Adverse events were ordinary and frequent. In the twelve-week study 42.6% reported headache and 88.9% reported at least one event once treatment began, at rates that tracked placebo. Five serious events appeared, three of them skin cancers plus one breast cancer and one melanoma, and investigators judged none related to the peptide. FDA’s surveillance reviewers were less settled, writing that they could not identify a safety signal from trials with mixed designs, populations, durations and formulations.

Weight loss, the reason anyone buys the vial, appears nowhere in the paper’s results. FDA states it: “The reference did not report data on effectiveness.”

The published alternatives are thinner. The twelve-week study reached print as a conference abstract, and FDA quotes its result: “Weight loss over 12 weeks was greater in the response to all doses of AOD-9604 than placebo, with a non-linear dose response. The largest effect occurred in the 1 mg dose and was ‘significant’ for females.” The mean rate of loss ran 0.22 kilograms a week at 1 milligram, 0.13 at 20 and 0.15 at 30, against 0.07 on placebo, a gap of about 1.8 kilograms across twelve weeks at the best dose, in an abstract with no published tables.

OPTIONS, the 24-week study with 536 participants, produced the result that matters most. FDA’s summary: “there was not a significant difference in the primary endpoint of weight loss between placebo and AOD-9604.” The company told the Australian exchange: “Trial results showed that weight loss compared to placebo at the primary and secondary endpoints of 12 or 24 weeks of treatment, was too low to reach statistical significance.” FDA adds that the study does not appear to have been published.

Taken together, the agency’s verdict is the one to keep: AOD-9604 “did not show a clinically meaningful weight loss outcome across the trial population,” a sentence FDA attributes to Cox and colleagues in 2015.

Where The 300 Microgram Number Comes From

We looked at the search results for this query on October 29, 2026. Six of the ten results on the first page printed a daily injection dose between 200 and 500 micrograms, one printed a count of daily injections, one declined to give a number and pointed readers to a prescriber, and the other two were a video and the safety paper above. None of the six cited a human study of subcutaneous AOD-9604.

Vials sold under the name come in milligrams. In July 2021 Innoveix Pharmaceuticals recalled injectable AOD-9604 3 milligram vials from four lots, AOD202, AOD205, AOD210 and AOD215, after a routine FDA inspection found a lack of sterility assurance. Three milligrams is ten times the 300 micrograms those charts print. The same FDA memo records that between 2017 and 2023 no outsourcing facility reported compounding any product containing AOD-9604, so the vials reaching patients came from pharmacies outside the reports FDA collects.

Reading An AOD-9604 Dosage Chart

Three questions separate a chart from a finding. Which route did the study use? What total daily amount did the trial give, and for how long? Has anyone published a trial of this route at this amount in humans?

A page that answers all three with a citation has done its job. A page that prints micrograms and syringe units without one has published a rumor with a decimal point. Doses vary by route, product and person, and the decision belongs to a prescriber who has examined the patient. Our clinic directory lists clinics by city, and each license is worth checking with the state board before booking. The compound status pages show where each peptide sits in the federal record, and our piece on TB-500 dosage applies the same test to another peptide sold on numbers no study supports.

What Would Settle The AOD-9604 Dosage Question

One study would do it: a phase 1 pharmacokinetic trial of subcutaneous AOD-9604 in humans, dose ranging, with blood levels and published tables. Nothing of the kind appears in the registry. A ClinicalTrials.gov search on October 29, 2026 for AOD9604 returned no registered studies, and a PubMed search that day returned 23 records, none a report of a completed human weight loss trial of the peptide.

Until then, the honest AOD-9604 dosage is the one a prescriber writes after reading the route question and the patient in front of them. The number on the internet is a sales figure wearing a lab coat.

Frequently asked questions

What is the standard AOD-9604 dosage?

No standard dose exists. The peptide is not an approved drug, and the six sponsored trials used intravenous infusions of 25 to 400 micrograms per kilogram or oral doses of 0.25 to 54 milligrams a day. A dose for one person requires a prescriber’s assessment.

Has AOD-9604 been tested as a subcutaneous injection?

No. In its December 4, 2024 evaluation FDA wrote that the nominations did not include, and the agency did not identify, human exposure data for AOD-9604 given subcutaneously or topically. Each human trial on record used an intravenous line or an oral capsule or tablet.

Did AOD-9604 cause weight loss in the trials?

Barely. The twelve-week study, reported as a conference abstract, showed a mean loss of 0.22 kilograms a week at 1 milligram against 0.07 on placebo, a gap near 1.8 kilograms over twelve weeks. The 24-week OPTIONS trial with 536 participants missed its primary endpoint.

Is AOD-9604 FDA approved?

No. It is not a component of any approved drug, no USP monograph exists for it, and FDA proposed not adding it to the compounding bulk list. Its entry on the significant safety risk page cites immunogenicity concerns and a lack of safety information.

Are the vials sold to patients the same thing the trials used?

Not the product or the route. The trials used peptide made under current good manufacturing practice by the sponsor and given by infusion or mouth. Compounded vials carry no FDA review for identity, purity, potency or sterility, as the 2021 Innoveix recall of four lots shows.

What side effects showed up in the human trials?

Headache led at 42.6% in the twelve-week study, with rates close to placebo. Five serious events occurred in that study, three of them skin cancers, and investigators judged none related to the peptide. The longest follow-up ran 24 weeks, short for a product sold as long term therapy.

Where do the primary documents sit?

The FDA briefing document of December 4, 2024, the agency’s safety risk page, the 2013 paper and the 2021 recall notice are linked below. Start with the memo, where a federal reviewer states what the trials did and did not show.

Sources:

This article is reporting on published labels and trial results for a directory of clinics and patients. It is not medical advice, and it does not tell anyone what to take.