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AOD-9604 Dosage Chart and Calculator: Protocol and Trial Data

AOD-9604 dosage chart: units per dose by vial size for the 250-500 mcg common protocol, a calculator, and the oral and IV doses its human safety trials used.

The short version

There is no FDA-approved or trial-established human dose for AOD-9604. The protocol most often used in practice is 250-500 mcg by subcutaneous injection once daily, fasted, for an 8-24 week cycle with a 4-8 week break. That is common practice, not something a trial established. The developer's human trials gave it by mouth or into a vein, never by subcutaneous injection. Only their safety data were published, and by the company's own account its Phase IIb obesity trial missed its goal. The rest is rodent studies, whose doses do not translate into a human number.

  • The protocol most often used is 250-500 mcg once daily, fasted, over an 8-24 week cycle with a 4-8 week break. It is common practice, not trial-established.
  • No human trial has established an effective AOD-9604 dose. By its developer's account the company-run obesity trial missed its goal, and its efficacy results were never published.
  • The developer's six human trials used oral doses of 0.25-54 mg a day or single intravenous doses, not subcutaneous injection. Their published data cover safety only.
  • Published animal dosing exists only in mice and rats, and those numbers are not a human dose in disguise.
  • AOD-9604 has no established half-life, so no human pharmacokinetic data back any dosing interval.

No trial has established an effective human dose of AOD-9604. This page states the protocol most often used in practice, labelled as common practice. It also covers what has been studied: oral and intravenous doses in the developer’s human safety trials, and doses in rodents. None of them is interchangeable with the protocol. Background on the compound itself, its failed obesity trial and its legal status is on the main AOD-9604 page.

AOD-9604 dosage: the common protocol

The protocol most often used is 250-500 mcg by subcutaneous injection once daily, fasted, for roughly 8-24 weeks with a 4-8 week break between cycles. No published human study gave AOD-9604 by subcutaneous injection, the route this protocol uses. The human trials below gave it by mouth or into a vein.

Common protocol

What is commonly used, not a dose established in trials. No regulator has set a dose for AOD-9604. Sources differ, so the ranges below span them.

Dose per administration
250-500 mcg
How often
once daily, fasted (some protocols run 5 days on, 2 days off)
Route
Subcutaneous injection
Cycle length
8-24 weeks
Break between cycles
4-8 weeks
Common vial size
5 mg
Timing
Morning, in a fasted state, waiting 20-60 minutes before eating.

300 mcg is described as the standard community starting point, with 500 mcg as an upper-end variation. Sources differ on cycle length (8 weeks on/8 off versus a longer 12-24 week run) and neither cites a published trial for the schedule.

Plan a cycle in the protocol builder or work out injection volume in the dosage calculator.

The common AOD-9604 dose is 250-500 mcg, once daily, fasted (some protocols run 5 days on, 2 days off). From a 5 mg vial mixed with 2 mL of bacteriostatic water, 400 mcg is 16 units (0.16 mL) on a U-100 insulin syringe.

AOD-9604 5 mg vial: units per dose

Full 5 mg vial page: mixing, doses per vial, how long it lasts →

Water addedConcentration1 unit =250 mcg400 mcg500 mcg
1 mL5 mg/mL50 mcg5 units8 units10 units
2 mL2.5 mg/mL25 mcg10 units16 units20 units
3 mL1.67 mg/mL16.67 mcg15 units24 units30 units

All AOD-9604 vial sizes: 2 mg · 5 mg

Units are on a standard U-100 insulin syringe (100 units = 1 mL), rounded to the nearest half unit - half-unit marks are on 0.3 mL syringes. Water volumes are examples: more water means more units per dose, not more doses per vial. For any other vial or dose, use the calculator below.

How many 5 mg vials a cycle takes

ScenarioDoseDoses a weekWeeksTotal5 mg vials
Low end of the common protocol250 mcg5810 mg2
High end of the common protocol500 mcg72484 mg17

Whole vials, rounded up. Plan a cycle with your own numbers in the protocol builder. Keep mixed vials cold and use them within the window in how long reconstituted peptides last; where to inject: subcutaneous injection sites.

The human trials: oral and intravenous doses, safety data only

The developer ran six randomised, double-blind, placebo-controlled trials of AOD-9604 between 2001 and 2006, in roughly 900 adults. Stier, Vos and Kenley published their safety data in 2013 in the Journal of Endocrinology and Metabolism (listed in this page’s sources). The developer funded all six trials, and the authors disclose ties to it. The doses were:

TrialRouteDoseDuration
Phase I, 15 healthy menIntravenous infusionSingle doses, 25-400 micrograms/kgSingle doses
Phase IIa, 23 obese menIntravenous infusionSingle doses, 25, 50 and 100 micrograms/kgSingle doses
Phase IIa, 17 obese menOral capsuleSingle doses, 9, 27 and 54 mgSingle doses
Phase IIa, 36 obese menOral capsule9, 27 or 54 mg daily7 days
Phase IIb, 300 obese adultsOral capsule1, 5, 10, 20 or 30 mg daily12 weeks
Phase IIb, 534 obese adults enrolled, 502 randomisedOral tablet0.25, 0.5 or 1 mg daily24 weeks

Two things follow.

  1. None of these trials used subcutaneous injection, so none tested the route or the 250-500 mcg dose of the common protocol above. An oral milligram dose of a peptide is not the same exposure as an injected microgram dose, and this page does not convert one into the other.
  2. The paper reports safety and tolerability only, not weight loss. As covered on the main guide, the company’s announcements and news reports on its 2007 discontinuation say its Phase IIb obesity trial did not meet its primary endpoint. The efficacy results were never published in a peer-reviewed paper, and the trial has no ClinicalTrials.gov entry.

The trials show which doses were given and tolerated, not which dose works.

Doses used in animal studies

Three peer-reviewed animal studies report specific AOD-9604 doses. None are in people, and none were designed to establish a human dose.

StudySpeciesRouteDoseDuration
Ng et al., Hormone Research, 2000 Ng 2000 - Ng FM, Sun J, Sharma L et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274-8., in the references belowObese Zucker ratsOral500 micrograms/kg body weight, daily19 days
Heffernan et al., Int J Obes, 2001 Heffernan 2001 - Heffernan MA, Thorburn AW, Fam B et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Int J Obes Relat Metab Disord. 2001;25(10):1442-9., in the references belowObese (ob/ob) mice, lean miceIntraperitoneal, via mini-osmotic pumpNot stated in micrograms/kg in the abstract; compared against human growth hormone at a matched schedule14 days
Heffernan et al., Endocrinology, 2001 Heffernan 2001 - Heffernan M, Summers RJ, Thorburn A et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Endocrinology. 2001;142(12):5182-9., in the references belowObese mice, beta-3-adrenergic-receptor knockout miceIntraperitonealNot stated in micrograms/kg in the abstract14 days

Only the rat study reports an exact dose in its abstract: 500 micrograms per kilogram of body weight, given orally once daily for 19 days. It reduced body-weight gain by over half against untreated controls Ng 2000 - Ng FM, Sun J, Sharma L et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274-8., in the references below. The two mouse studies confirm reduced body weight and increased fat oxidation with daily dosing over 14 days. Neither gives an exact microgram-per-kilogram figure in the published abstract Heffernan 2001 - Heffernan MA, Thorburn AW, Fam B et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Int J Obes Relat Metab Disord. 2001;25(10):1442-9., in the references belowHeffernan 2001 - Heffernan M, Summers RJ, Thorburn A et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Endocrinology. 2001;142(12):5182-9., in the references below.

What is not established

  • No published human trial has established an effective dose, frequency or duration. By its developer’s account the company-run obesity trial missed its primary endpoint, and its efficacy results were never published. The common protocol above is compiled from circulating clinic and community sources, not from a trial.
  • No established human half-life. Nothing on the main AOD-9604 page or in the sources above gives a human pharmacokinetic figure, so no dosing interval can be built from one.
  • No approved product, so no label to defer to. FDA lists AOD-9604 among bulk substances nominated but withdrawn from its compounding safety review, not among anything cleared for use.

How to reconstitute AOD-9604

Working out how many milligrams end up in a given syringe mark for a stated vial size and diluent volume is arithmetic, not a dosing recommendation. Use the dosage calculator for it. The tool does the maths for whatever number you enter. It does not supply a dose, because this page has none to give it.

Who should not use it, the risks, and when to stop

Full detail on AOD-9604’s legal status and its regulatory safety flags is on the main page. In short, FDA makes three points about compounded drugs containing AOD-9604:

  • They “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, and “the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.”
  • FDA has identified serious adverse events that may be associated with AOD-9604, “though causality is not clear.”

These people should not use it:

  • anyone with a known peptide hypersensitivity
  • anyone pregnant or breastfeeding
  • anyone using it in place of an evaluation by a prescriber

AOD-9604 dosage calculator

Preset to a 5 mg vial and 250 mcg, the low end of the common protocol. Enter your own vial size, water and dose to get the syringe units to draw.

Your vial

Printed on the vial. There is no standard size - enter what yours says.

This changes how much you draw - never how many doses the vial holds.


100 units per mL. 1 unit = 0.01 mL. This is what almost every insulin syringe sold is, in every barrel size.

Barrel size

Capacity only. A 1 mL U-100 syringe holds 100 units - the scale decides that, not the barrel.

Draw this much

10units

= 0.1 mL on a 1 mL U-100 syringe

Concentration
2,500 mcg/mL
Exact volume
0.1 mL
Dose you actually get
250 mcg
Doses per vial(unaffected by water volume)
20

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Where to buy AOD-9604 for research

Each vendor is checked against my vendor checklist.

  1. 1.Next Level PharmFeatured

    5 mg vial

    • No FDA warning letter found
    • Names its testing lab
    • Batch COAs published
    • Takes card payment
  2. 2.Spartan Peptides

    5 mg vial

    • No FDA warning letter found
    • Names its testing lab
  3. 3.BioEdge Research Labs

    5 mg vial

    • No FDA warning letter found
    • Names its testing lab
    • Batch COAs published

Compare every checked vendor for AOD-9604 →

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Common questions

What is the usual AOD-9604 dose?

The protocol most often used is 250-500 mcg by subcutaneous injection once daily, in a fasted state, for roughly 8-24 weeks with a 4-8 week break between cycles. That is common practice compiled from circulating clinic and community protocols. No regulator or published human study has established it.

What doses have actually been studied?

In people, only by mouth or into a vein. The developer's six randomised, placebo-controlled trials gave single intravenous doses of 25-400 micrograms per kilogram and oral doses from 0.25 mg to 54 mg a day. Stier, Vos and Kenley published their safety data in 2013. The longest trial ran 24 weeks on 0.25, 0.5 or 1 mg daily by tablet (534 enrolled, 502 randomised). None used subcutaneous injection, and their efficacy results were never published. In animals, a rat study gave AOD-9604 orally at 500 micrograms per kilogram of body weight daily for 19 days. Mouse studies gave it by daily injection into the abdomen for 14 days, without reporting the exact dose in the abstract. None of these establishes a dose for the injected protocol.

Can I convert the animal dose to a human dose?

No, and I'm not going to do that math for you. Converting an animal dose to a human one requires pharmacokinetic modelling that has never been published for AOD-9604. A generic formula would produce a number that looks precise and is not backed by any study. This site does not publish invented precision like that.

How often should AOD-9604 be dosed?

No published human trial has established a dosing interval. AOD-9604 also has no established human half-life in the literature I could verify, and an interval would normally be built from that number. In practice, common protocols use once daily, fasted, sometimes 5 days on and 2 days off. That is a convention compiled from circulating clinic and community sources, not a trial finding.

How long is a typical AOD-9604 cycle?

No regulator or published human trial has established a cycle length. The animal studies above ran 14 to 19 days, in rodents, for a different purpose than defining a human schedule. Circulating protocols vary from 8 weeks on/8 off to a longer 12-24 week run, and some sources describe a 4-8 week break. That is common practice, not a trial-established schedule.

Does the reconstitution math change any of this?

No. Reconstitution is arithmetic: how many milligrams end up in each syringe mark for a given vial size and diluent volume. It is not a judgment about what dose to use. The dosage calculator below does that arithmetic. It does not supply a dose, because there is no established one to enter.

References (6 sources)

Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.

  1. 1.Ng FM, Sun J, Sharma L et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274-8.StudyPMID 11146367
  2. 2.Heffernan MA, Thorburn AW, Fam B et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Int J Obes Relat Metab Disord. 2001;25(10):1442-9.StudyPMID 11673763
  3. 3.Heffernan M, Summers RJ, Thorburn A et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Endocrinology. 2001;142(12):5182-9.StudyPMID 11713213
  4. 4.FDA - Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. Lists AOD-9604 among substances nominated but withdrawn, and states the immunogenicity, impurity and adverse-event concerns quoted on this page.- US Food and Drug Administrationregulatory
  5. 5.Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15. Open-access summary of the safety data from six randomised, double-blind, placebo-controlled trials (oral and intravenous dosing), funded by the developer; it reports safety and tolerability, not efficacy. Source for the human trial doses and safety findings on this page.- Journal of Endocrinology and Metabolism (Elmer Press)other
  6. 6.Poison Control (America's Poison Centers) - confirms the US poison-help hotline number given on this page.- America's Poison Centersother