AOD-9604 · Dose evidence · updated 8 October 2026
AOD-9604 dosage: what studies actually used
The short answer
AOD-9604 is a lab-made fragment of human growth hormone, and no dose is established for any use: FDA has not approved it, and a 2026 review says no major regulatory agency has12. Its developer tested it in 893 adults in six trials from 2001 to 2006, as single IV infusions of 25 to 400 µg/kg or by mouth at 0.25 to 54 mg a day3. In the largest trial, 502 adults with obesity were randomized to 0.25, 0.5 or 1 mg a day or placebo for 24 weeks, and weight loss compared with placebo was too small to reach statistical significance13. Its 2012 ‘self-affirmed conditional GRAS’ status was a claim about use in food, not a drug approval4.
Not dosing advice. This page reports doses that studies and approved labels used, with their sources. It does not recommend a dose, and we do not give mixing, injection or unit-conversion instructions. Gray-market vials often do not contain what their label says. How we report doses.
Every dose studied in people
| Study | Who | People | Dose and route | What happened |
|---|---|---|---|---|
| OPTIONS (METAOD006), randomized, double-blind, placebo-controlled; weight results only in company announcements | Adults aged 18 to 65 with obesity, BMI (body mass index) 30 to 45, at 16 Australian hospitals and medical centers; 44% men | 502 | 0.25, 0.5 or 1 mg once a day, or placebo, alongside a dietitian-supervised diet and exercise program By mouth (tablets) · 24 weeks, after a 4-week placebo run-in, then 4 weeks of follow-up |
Weight loss compared with placebo at 12 and 24 weeks was ‘too low to reach statistical significance’, and on 21 February 2007 the company announced it had ended development for obesity1. During treatment 78.7% had at least one side effect, from 75.6% on 0.25 mg to 83.2% on placebo, and 18 of 502 (3.6%) had a serious adverse event, 8 of them on placebo3. |
| METAOD005 (Herd 2005), randomized, double-blind, placebo-controlled; weight results only in a meeting abstract | Men and women aged 30 to 65 with a BMI of 35 or more, at 5 Australian hospitals; 54% men | 300 | 1, 5, 10, 20 or 30 mg once a day, or placebo (50 people per group) By mouth (capsules) · 12 weeks, after a 2-week placebo run-in |
Weekly weight loss was 0.22 kg on 1 mg, 0.13 kg on 20 mg and 0.15 kg on 30 mg, against 0.07 kg on placebo; the 1 mg result was called ‘significant’ for women, and FDA said the abstract gave too little detail to judge1. Five people had serious adverse events: basal cell carcinoma, lipoma and squamous cell carcinoma on 20 mg, breast cancer on 5 mg and melanoma on 10 mg3. The investigator judged none related, but FDA said there was too little information to assess that13. |
| METAOD004, randomized, double-blind, placebo-controlled dose-escalation trial | Men aged 18 to 54 with a BMI of 30 or more | 36 | 9, 27 or 54 mg a day, or placebo (9 men per group) By mouth (capsules) · 7 days, then 7 days of follow-up |
All 36 men reported side effects, 207 in total, none serious; headaches, diarrhea and flatulence were more common at 54 mg, and IGF-1 (a growth factor that growth hormone raises), fasting glucose and insulin did not change3. FDA’s account of a 2004 summary of what appears to be this trial gives doses of 10, 30 or 60 mg and weight loss over the week of 1 kg on 10 mg against 0.6 kg on placebo1. |
| METAOD002, double-blind, placebo-controlled crossover | Men aged 19 to 50 with obesity (BMI 36 to 67) | 23 | Single doses of 25, 50 and 100 µg/kg, and placebo Infusion into a vein (IV) · 4 single doses, 7 days apart |
There were 118 side effects and no serious ones; 16 of 23 men (69.6%) had headaches, one severe episode of chest tightness at 50 µg/kg was judged possibly related, and 5 men reported mild or moderate euphoria during AOD-9604 periods3. FDA reports average weight loss of 0.58 kg over 3 weeks, not statistically different from placebo1. |
| METAOD003, double-blind, placebo-controlled crossover | Men aged 35 to 54 with a BMI of 35 or more | 17 | Single doses of 9, 27 and 54 mg, and placebo By mouth (capsules) · 4 single doses, 2 weeks apart; 15 men finished |
All 17 men reported side effects, 97 in total; 2 were serious, both on 54 mg: diarrhea judged ‘possibly related’ and bronchial pneumonia judged ‘unrelated’3. FDA’s account of what appears to be this trial reports ‘no statistically significant weight loss compared with placebo’1. |
| METAOD001, double-blind, placebo-controlled dose-escalation study | Healthy men with a BMI of 24 to 30 | 15 | 3 single doses in the range 25 to 400 µg/kg, and placebo; one dose of growth hormone for comparison Infusion into a vein (IV) · Single doses 7 days apart; 14 men finished |
Twelve men reported 29 side effects, none serious, most often headache (6 times), and the authors saw ‘no significant glycerol, glucose or IGF-1 trends’3. |
Studies, animals and users: kept apart
Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.
In human studies
Single 20-minute IV infusions of 25 to 400 µg/kg in healthy men, and 25, 50 and 100 µg/kg in men with obesity3. By mouth: single doses of 9, 27 and 54 mg; 9, 27 or 54 mg daily for 7 days; 1, 5, 10, 20 or 30 mg daily for 12 weeks; and 0.25, 0.5 or 1 mg daily for 24 weeks3. The company’s 2012 food-ingredient determination covered up to 1 mg per person per day4. No dose has been studied in humans for injection under the skin, a main form sold, or for skin creams1.
In animal studies
Obese Zucker rats: 500 µg/kg a day by mouth for 19 days6. Obese mice: 250 µg/kg a day for 14 days, by pump under the skin or by injection into the abdomen1. Rabbits with enzyme-induced knee arthritis: 0.25 mg injected into the knee once a week in weeks 4 to 77. Toxicity studies: 0.1, 1 or 10 mg/kg a day IV for 4 weeks in rats; 0.5, 20 or 100 mg/kg a day by mouth for 26 weeks in rats; and 0.5, 10 or 50 mg/kg a day by mouth for 9 months in monkeys18. Pig absorption study: 400 µg/kg IV and 2 mg/kg by mouth18. These are animal research doses, not human doses.
Half-life and how it is taken
- Half-life
- About 3 minutes in pigs after an IV dose; unknown in humans8Animal and lab data only. In pigs given 400 µg/kg into a vein, blood levels peaked at 2 minutes and fell with a half-life of about 3 minutes18. In rat plasma (the liquid part of blood) kept at room temperature in a test tube, the half-life was about 4 minutes; the peptide was trimmed from its front end and gone by 56 minutes8. In lab tests in serum, one breakdown product (CRSVEGSCG) was more stable than the parent peptide and its other breakdown products9. Oral doses in pigs gave blood levels that implied an impossible 170% absorption, so FDA called oral absorption unclear even in animals1. FDA found no human data on absorption or clearance by any route1.
- Routes
- By mouth (capsules, tablets): human trials up to 24 weeks
- Into a vein (IV infusion): single doses in two small human trials
- Injection under the skin: a main form sold by clinics and online; no human data found
- Troches and dissolving tablets: marketed by clinics; no study of these forms found
- Skin cream (transdermal): proposed for compounding and used in a cosmetic anti-cellulite cream; no human data found
- Injection into a muscle: on the label of a recalled compounded product; no human data found
- Injection into the knee joint: one rabbit study
- Pump under the skin or injection into the abdominal cavity: mouse studies only
What the 2012 food-ingredient claim covers
On 25 June 2012, AOD-9604’s developer announced a ‘self-affirmed conditional GRAS’ status: it had contracted a firm, GRAS Associates, to evaluate AOD-9604’s safety as a food ingredient, and a panel of US experts deemed it ‘Generally Recognised As Safe’ (GRAS)4. GRAS is a category from the 1958 Food Additives Amendment that exempts some food ingredients from FDA’s premarket approval of food additives4.
The announcement said full GRAS status depended on publishing the company’s safety studies in a peer-reviewed journal4. Companies may tell FDA about a GRAS conclusion voluntarily, and FDA’s inventory of GRAS notices listed no AOD-9604 notice on 5 October 2026410.
The announcement said the panel found that AOD-9604 ‘can be consumed at total per capita levels of 1 mg per day’, a level for intake from food, not a dose shown to work: in the largest trial, up to 1 mg a day for 24 weeks did not beat placebo by a statistically significant margin14. The claim covered use as a food ingredient, not use as a drug4.
Where AOD-9604 stands with regulators
AOD-9604 is not approved by FDA for any use and is not part of any FDA-approved drug1. A 2026 medical review says no major regulatory agency has approved it for any use2. Key dates:
- 29 September 2023: FDA placed it in Category 2 of its interim list for pharmacy compounding, substances that raise significant safety risks11.
- 19 September 2024: FDA received withdrawals from both pharmacies that had nominated it1213.
- 5 November 2024: FDA staff proposed not adding it to the list of substances US pharmacies may compound, citing no evidence that it works and limited safety data among other reasons1.
- 4 December 2024: FDA’s compounding advisers voted 0 for and 12 against adding it, with no abstentions14.
- 14 May 2026: it was in no category of FDA’s updated list, so US pharmacies cannot lawfully compound it for individual patients under section 503A of federal drug law15.
- 25 September 2026: it was not a federally controlled substance16.
- 1 October 2026: Australia’s Poisons Standard in force from this date lists it as a prescription-only (Schedule 4) poison and in Appendix D clause 5, which makes possession without authority illegal17. FDA’s 2024 review had already noted that an Australian scheduling committee recommended adding it1.
- In sport: banned at all times under the World Anti-Doping Agency’s 2026 Prohibited List, and the 2027 List, in force from 1 January 2027, keeps the same wording1819.
Why no dose is established
FDA’s 2024 review found ‘a lack of evidence to support the effectiveness’ of AOD-9604 for obesity by any route, and ‘insufficient information to support patient safety for the long-term use’1. Only the safety results of the trials were published in a journal, by authors tied to the company; the weight results come from company announcements, a 2005 meeting abstract and a 2004 summary13.
The trial doses come in two units, micrograms per kilogram of body weight for the IV infusions and milligrams a day for the pills, and we do not convert one into the other3.
The sources also disagree on some trial details13. For the 7-day trial, the 2013 safety paper gives 9, 27 or 54 mg a day, while FDA’s account of a 2004 summary gives 10, 30 or 60 mg13. FDA counts 16 men in the single-dose pill trial where the paper counts 17, describes the IV trial in men with obesity as weekly doses for 4 weeks, and says 536 people enrolled in the largest trial, where the paper says 534; both give 502 randomized13.
AOD-9604 is not growth hormone or hGH 176-191
AOD-9604 copies the last 15 amino acids of human growth hormone, positions 177 to 191, and adds one tyrosine at the front, so it is a different molecule from full-length growth hormone, whose doses do not carry over to it3. The fragment sold as hGH 176-191 has phenylalanine where AOD-9604 has that tyrosine, so it is a different molecule too, and its doses do not carry over either20.
Questions people ask
How much AOD-9604 should I take?
No dose is established for any use, and FDA found ‘a lack of evidence to support the effectiveness’ of AOD-9604 for obesity by any route1. Trials gave single IV infusions of 25 to 400 µg/kg or 0.25 to 54 mg a day by mouth3. AOD-9604 is not an FDA-approved drug, and US pharmacies may not compound it11521.
What is the AOD-9604 dose for weight loss?
No dose has been shown to work for weight loss: in the largest trial, 0.25, 0.5 or 1 mg a day for 24 weeks did not beat placebo by a statistically significant margin1. The best figure, 0.22 kg a week on 1 mg against 0.07 kg on placebo, comes from a 12-week trial reported only in a meeting abstract that FDA said gave too little detail to judge1.
How long does AOD-9604 take to work?
Studies give no timeline, because FDA found ‘a lack of evidence to support the effectiveness’ of AOD-9604 for obesity1. In the longest trial, weight loss compared with placebo after 12 and 24 weeks was too low to reach statistical significance1.
Is AOD-9604 approved as a food ingredient?
Not by FDA: its 2012 ‘self-affirmed conditional GRAS’ status came from an expert evaluation the developer commissioned, and FDA’s inventory of GRAS notices listed no AOD-9604 notice on 5 October 2026410. GRAS covers use in food and is not approval as a drug4.
Go deeper
Sources
- 1FDA Briefing Document, Pharmacy Compounding Advisory Committee meeting of December 4, 2024: FDA Evaluation of AOD-9604-Related Bulk Drug Substances (AOD-9604 (free base) and AOD-9604 acetate) U.S. Food and Drug Administration, 5 Nov 2024. fda.gov
- 2The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration Frontiers in Endocrinology, 2026. pubmed.ncbi.nlm.nih.gov
- 3Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans Journal of Endocrinology and Metabolism, Apr 2013. jofem.org
- 4AOD9604 Receives GRAS Status (ASX announcement) Calzada Limited, 25 Jun 2012. aspecthuntley.com.au
- 5AOD-9604 Dosage, Safety & Stacks Peptide Initiative, 10 Aug 2026. peptideinitiative.com
- 6Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone Hormone Research, 2000. pubmed.ncbi.nlm.nih.gov
- 7Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model Annals of Clinical and Laboratory Science, 2015. pubmed.ncbi.nlm.nih.gov
- 8Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health Journal of Endocrinology and Metabolism, Jun 2014. jofem.org
- 9Detection and in vitro metabolism of AOD9604 Drug Testing and Analysis, Jan 2015. pubmed.ncbi.nlm.nih.gov
- 10GRAS Notice Inventory: search for ‘9604’ (Records Found: 0) U.S. Food and Drug Administration, accessed 5 Oct 2026. hfpappexternal.fda.gov
- 11Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list updated 29 September 2023) U.S. Food and Drug Administration (copy hosted by the Alliance for Pharmacy Compounding), 29 Sep 2023. join.a4pc.org
- 12Withdrawal from Wells Pharmacy Network (FDA-2015-N-3534-0471) Regulations.gov (U.S. Food and Drug Administration docket FDA-2015-N-3534), 19 Sep 2024. regulations.gov
- 13Withdrawal from LDT Health Solutions, Inc (FDA-2015-N-3534-0472) Regulations.gov (U.S. Food and Drug Administration docket FDA-2015-N-3534), 20 Sep 2024. regulations.gov
- 14Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024 U.S. Food and Drug Administration, 21 Feb 2025. fda.gov
- 15Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
- 1621 CFR Part 1308, Schedules of Controlled Substances (eCFR, as of 25 September 2026) Electronic Code of Federal Regulations (eCFR), 25 Sep 2026. ecfr.gov
- 17Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327) Federal Register of Legislation, Australian Government, 28 Sep 2026. legislation.gov.au
- 18World Anti-Doping Code International Standard: Prohibited List 2026 World Anti-Doping Agency, 24 Sep 2025. wada-ama.org
- 19World Anti-Doping Code International Standard: Prohibited List 2027 World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
- 20P01241 SOMA_HUMAN: Somatotropin (human growth hormone, GH1) UniProt, accessed 5 Oct 2026. uniprot.org
- 21Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration, 22 Apr 2026. fda.gov
Not medical advice. Talk to a licensed clinician before using any drug. Report an error.