AOD-9604 Dosage: The Six Trials' Doses and Units per Vial

Six sponsor trials gave AOD-9604 by mouth at 0.25 to 54 mg and by vein at 25 to 400 mcg/kg, never under the skin; reported with dates and units per vial.

Medibact Guides · Published 2026-09-18

Illustration: A clear glass vial with pale blue liquid on a white surface, lit by natural light.
Illustration

AOD-9604 has one of the fullest human dosing records of any compound in this catalogue and almost none of it is by the route anyone uses. Six placebo-controlled trials, 893 subjects, doses from a quarter of a milligram to 54 milligrams a day, all swallowed, and two intravenous studies on top; not one subcutaneous injection. This page reports the trial doses as the sponsor's paper states them, then the vendor figures, and then works the units for the 2 mg, 5 mg and 10 mg vials the site's calculator uses, with the gap between the two sets left visible.

AOD-9604 is a 16-amino-acid peptide corresponding to residues 177 to 191 of human growth hormone with a stabilising tyrosine at the N-terminus, designed to keep the lipolytic region of the hormone without its growth-promoting action. Medibact's AOD-9604 guide covers the molecule, the failed programme and its evidence; this page stays with figures. The dosage hub lists every compound's page, and Peptifact's AOD-9604 dosage page grades the same sources from a journalist's angle.

What the sources state

Source Kind Route Figure Date read
DailyMed search, "AOD9604" Label search Any Zero records; no approved product 2026-09-18
ClinicalTrials.gov search, "AOD9604 OR AOD-9604" Registry Any Zero studies (the trials predate mandatory registration) 2026-09-18
METAOD001 (Stier et al. 2013) Trial protocol (phase 1) Intravenous, 20-minute infusion Three single doses per subject from 25 to 400 mcg/kg, 7-day washouts; 15 healthy men; 14 completed 2026-09-18
METAOD002 Trial protocol (phase 2a) Intravenous, 20-minute infusion Single doses of 25, 50 and 100 mcg/kg and placebo, Latin square; 23 obese men 2026-09-18
METAOD003 Trial protocol (phase 2a) Oral capsule Single doses of 9, 27 and 54 mg, 2-week washouts; 17 obese men 2026-09-18
METAOD004 Trial protocol (phase 2a) Oral capsule 9, 27 or 54 mg daily for 7 days; 36 obese men, 9 per group 2026-09-18
METAOD005 Trial protocol (phase 2b) Oral capsule 1, 5, 10, 20 or 30 mg once daily for 12 weeks after a 2-week placebo run-in; 300 obese adults, 50 per group, 5 hospitals 2026-09-18
METAOD006 Trial protocol (phase 2b) Oral tablet 0.25, 0.5 or 1 mg once daily for 24 weeks after a 4-week run-in; 502 obese adults randomised (534 enrolled), 16 centres 2026-09-18
Ng et al., Hormone Research 2000 (PMID 11146367) Animal study Oral (rats) 500 mcg/kg for 19 days; body-weight gain halved 2026-09-18
Vendor and protocol pages Commonly cited Subcutaneous 250 to 500 mcg once daily; 300 mcg most cited, morning, fasted; 300 mcg for 4 weeks then 500 mcg; 8 to 24 weeks; 5 mg vial at 3 mL 2026-09-18

The trial doses and the vendor dose cannot be compared as amounts, because a swallowed peptide and an injected one are not the same exposure and nobody has measured AOD-9604's oral bioavailability in a paper PubMed indexes. What can be said is narrower: the subcutaneous route on every vendor page is a route the sponsor never tested in a person.

The intravenous doses in milligrams

Because the two infusion studies report per-kilogram doses, the milligram equivalents are worth setting out, as this page's arithmetic rather than the paper's. At 70 kg, 25 mcg/kg is 1.75 mg, 50 mcg/kg is 3.5 mg, 100 mcg/kg is 7 mg and 400 mcg/kg is 28 mg. The lowest of those is already six times the vendor pages' 300 mcg; the highest is nearly three of the largest research vials. The paper reports no clinically significant change in vital signs, laboratory tests or ECG at any of them and no IGF-1 or glucose trend, and it is careful to attach those findings to single doses in a study setting.

Units per dose at each research-vial size

Research-market AOD-9604 is supplied in 2 mg, 5 mg and 10 mg vials. The table takes each at 1, 2 and 3 mL, states the concentration, and converts the vendor figures (250, 300 and 500 mcg and 1 mg) and the lowest trial dose at 70 kg (1.75 mg) into U-100 syringe units, where 100 units is 1 mL (MedlinePlus, read 2026-09-18); the site's insulin syringe units page covers the syringe reading itself. The 1.75 mg column is there to show scale; it was an intravenous infusion, not a draw.

Vial Water added Concentration 250 mcg 300 mcg 500 mcg 1 mg 1.75 mg
2 mg 1 mL 2 mg/mL 12.5 15 25 50 87.5
2 mg 2 mL 1 mg/mL 25 30 50 100 175 (>1 syringe)
2 mg 3 mL 0.67 mg/mL 37.5 45 75 150 (>1 syringe) 262.5 (>1 syringe)
5 mg 1 mL 5 mg/mL 5 6 10 20 35
5 mg 2 mL 2.5 mg/mL 10 12 20 40 70
5 mg 3 mL 1.67 mg/mL 15 18 30 60 105 (>1 syringe)
10 mg 1 mL 10 mg/mL 2.5 3 5 10 17.5
10 mg 2 mL 5 mg/mL 5 6 10 20 35
10 mg 3 mL 3.33 mg/mL 7.5 9 15 30 52.5

The 2 mg vial is the one this site's calculator note flags: at 2 mL it is 1 mg/mL, and a 300 mcg draw is 30 units, five times the 6 units the same amount is from a 5 mg vial at 1 mL, an easy factor to lose when a figure is copied between vial sizes. A 5 mg vial holds sixteen 300 mcg amounts and a 10 mg vial thirty-three, whichever water volume is used. The AOD-9604 calculator works any combination entered, the site's AOD-9604 reconstitution page covers water volumes per vial and the mixing steps as references describe them, and the reconstitution chart lists the same concentrations for every compound.

What the figures omit

The trial figures carry a population (healthy or obese adults, men only in the first four studies), a route, a schedule, a duration and a sponsor; they carry no subcutaneous data and, in the 2013 paper, no weight outcome. The vendor figures carry a route, a timing rule and a course of 8 to 24 weeks, the longer end borrowed from the oral trials' duration without the oral trials' route; they carry no population, no endpoint and no bioavailability figure to connect them to anything measured. Neither set says what the fragment does when injected under the skin daily for months, because that has not been studied in a person.

What this page does not do

This page reports figures with their sources and dates and converts them into syringe units at the site's vial sizes. It does not recommend a dose, a route, a frequency or a course for anyone, does not say whether the vendor convention works, and does not turn it into advice. The mixing steps and the storage of a mixed vial are the store's topics: how to reconstitute peptides and how to store peptides on medibact.com.

Sources and dates

Opened 2026-09-18: the DailyMed SPL search API for "AOD9604" (zero records); the ClinicalTrials.gov v2 API for "AOD9604 OR AOD-9604" (zero studies); the full text of Stier, Vos and Kenley, Journal of Endocrinology and Metabolism 2013;3(1-2):7-15 (open access, doi 10.4021/jem157w), for the six trial designs, doses, subject numbers and Tables 1 and 2; PubMed through the NCBI E-utilities for the census (22 records) and the abstracts of PMIDs 24124033, 11146367, 11673763, 11713213 and 16931496; FDA's GRAS notice inventory searches for "AOD9604" and "hexadecapeptide" (no records); one vendor protocol page (a clinic page timed out and was not read); and MedlinePlus for the U-100 definition. Corrections go to the contact page.

Frequently asked questions

What is the AOD-9604 dosage?

There is no labelled dose. The only human dosing record is the sponsor's six trials, summarised in 2013: single intravenous infusions of 25 to 400 mcg/kg, oral single doses of 9 to 54 mg, oral 9 to 54 mg daily for a week, oral 1 to 30 mg daily for 12 weeks and oral 0.25 to 1 mg tablets daily for 24 weeks. None was subcutaneous. Vendor pages read on 2026-09-18 state 250 to 500 mcg subcutaneously once daily, most often 300 mcg. This page reports both sets with sources and dates.

How many units is 300 mcg of AOD-9604?

It depends on the concentration. At 1.67 mg/mL, which a 5 mg vial reaches with 3 mL of water and which the vendor pages use, 300 mcg is 0.18 mL, or 18 units on a U-100 syringe. At 2.5 mg/mL (5 mg vial, 2 mL) it is 12 units; at 5 mg/mL (5 mg vial, 1 mL, or 10 mg vial, 2 mL) it is 6 units; at 2 mg/mL (2 mg vial, 1 mL) it is 15 units; at 10 mg/mL it is 3 units. The table on this page works all three vials at 1, 2 and 3 mL.

Is there an AOD-9604 dosage chart?

The table on this page is one for the 2 mg, 5 mg and 10 mg vials at 1, 2 and 3 mL. It converts the vendor figures of 250, 300 and 500 mcg and 1 mg, and the trials' lowest intravenous dose of 25 mcg/kg at 70 kg (1.75 mg), into syringe units. The trials' larger intravenous doses, up to 28 mg at 70 kg, exceed any research vial and are not on the chart; they were 20-minute infusions in a study ward, not draws.

What is the AOD-9604 protocol in the trials?

Six regimens, all oral or intravenous. METAOD001 and 002 were single intravenous infusions over 20 minutes, separated by 7-day washouts. METAOD003 was single oral doses of 9, 27 and 54 mg two weeks apart. METAOD004 was 9, 27 or 54 mg orally daily for 7 days. METAOD005 was 1, 5, 10, 20 or 30 mg orally daily for 12 weeks after a 2-week placebo run-in. METAOD006 was 0.25, 0.5 or 1 mg tablets daily for 24 weeks after a 4-week run-in. The 8-to-24-week subcutaneous courses on vendor pages appear in none of them.

Did the AOD-9604 trials show weight loss?

The 2013 paper does not say; it is a safety and tolerability summary and reports IGF-1, glucose tolerance, antibodies and adverse events, not the weight endpoints of the two long studies. What it does record is that the largest study, 24 weeks at 0.25 to 1 mg daily, was the last, and the compound's obesity development ended after it. The weight results of those trials were never published in a journal that PubMed indexes; the abstract-level record on 2026-09-18 holds 22 papers, none of them a primary weight trial.

Is AOD-9604 GRAS or FDA-approved?

Neither in the sense the search implies. It is not an approved drug: a DailyMed search on 2026-09-18 found no label, and no trial is registered. The 2013 paper says a GRAS panel determined it generally recognised as safe under its intended uses in foods, which is a self-determination by experts the company convened, not an FDA decision. Searches of FDA's GRAS notice inventory for 'AOD9604' and 'hexadecapeptide' on 2026-09-18 returned no records, so no FDA response letter was found.