Not approved, and it failed its trialsAOD-9604 is not FDA-approved.[1] The FDA says it "identified serious adverse events that may be associated with AOD-9604, though causality is not clear."[2] This calculator only converts numbers you enter.
What is the AOD-9604 peptide?
AOD-9604 is a modified piece of human growth hormone: the hormone's residues 177–191 with an extra tyrosine at the start, held in a loop by a disulfide bond.[14][4]
- Sequence
- YLRIVQCRSVEGSCGF (Tyr-hGH 177–191), disulfide between the two cysteines[14]
- Formula and weight
- C78H123N23O23S2, 1,815.1 g/mol
- Developer
- Metabolic Pharmaceuticals Ltd, Australia, late 1990s[4]
- Check it yourself
- Enter the sequence with 1 disulfide bond in the molecular weight calculator.
Regulatory status
AOD-9604 has no approval anywhere we could find, and the FDA has recommended against allowing it in pharmacy compounding.
| Date | What happened |
|---|---|
| Sept 29, 2023 | Placed in FDA's 503A Category 2 (significant safety risks)[3] |
| Sept 27, 2024 | Removed from Category 2 after the nominations were withdrawn; FDA's safety wording stays on its page |
| Dec 4, 2024[4][5] | FDA proposes not adding it to the 503A bulks list; the advisory committee votes 0 yes, 12 no |
| Oct 30, 2026[6] | Not included in the HHS enforcement-discretion policy for six peptides |
- Cancer reports. FDA: "We have concerns about the reports of various cancers reported with the 12-week study of oral AOD-9604 administration; information is insufficient whether these various types of cancers were unrelated to AOD-9604."[4]
- GRAS. There is no AOD-9604 notice in FDA's GRAS Notice Inventory.[7] A sponsor-commissioned panel's GRAS opinion is not an FDA decision.[8]
- Enforcement. A 2020 FDA warning letter listed AOD-9604 as ineligible for compounding,[9] and in 2021 a compounder recalled AOD-9604 injections "due to a lack of sterility assurance".[10]
- Australia lists AOD-9604 in Schedule 4 and Appendix D of its Poisons Standard, a scheduling control, not an approval.[11]
- Sport. WADA 2026 S2.2.3 names "growth hormone fragments, e.g. AOD-9604 and hGH 176-191"; USADA lists it under S2 on the 2027 list as well.[12][13] See are peptides banned in sports?
AOD-9604 dosage in human trials
Six sponsor trials from 2001 to 2006 gave AOD-9604 intravenously or by mouth; none tested injection under the skin, and the largest missed its weight-loss goal.[8][4]
| Trial | People | Amount and route studied | Reported |
|---|---|---|---|
| Phase 1 (METAOD001) | 15 healthy men | Single IV infusions, 25–400 µg/kg | No serious adverse events; mostly headache and fatigue |
| Phase 2a (METAOD002) | 23 obese men | Single IV doses, 25–100 µg/kg | One severe chest tightness, possibly related; no weight difference vs placebo per FDA |
| Phase 2a (METAOD003) | 17 obese men | Single oral doses, 9–54 mg | Two serious events at 54 mg (diarrhea, possibly related; pneumonia, unrelated) |
| Phase 2a (METAOD004) | 36 obese men | Oral 9–54 mg daily for 7 days | More headache, diarrhea and flatulence at 54 mg |
| Phase 2b (METAOD005) | 300 obese adults | Oral 1–30 mg daily for 12 weeks | Meeting abstract only; several cancers reported as serious events, judged unrelated by the investigator |
| Phase 2b OPTIONS (METAOD006) | 502 randomized | Oral 0.25–1 mg daily for 24 weeks | Primary endpoint not met; obesity development terminated in 2007 |
The FDA's summary: "In most of the studies we identified, AOD-9604 failed to show benefit for weight reduction when compared to placebo." It found no human pharmacokinetic data and no human data for injection under the skin or on the skin.[4] The amounts above are what the trials used, per kilogram or in milligrams by mouth; they are not doses for anyone.
AOD-9604 side effects in the trials
In the sponsor's trials the most common side effects were headache and fatigue, with more stomach complaints at high oral doses; cancers reported in one 12-week study remain unexplained.[8][4]
- Common: headache and fatigue after IV doses; headache, diarrhea and flatulence at 54 mg by mouth.[8]
- Serious or notable: one severe "feeling of chest tightness" after an IV dose, judged possibly related; diarrhea at 54 mg judged possibly related.[8]
- Cancers: basal cell, squamous cell, breast cancer and melanoma were reported in the 12-week oral study; the investigator judged none related, and the FDA called the information "insufficient".[8][4]
- Antibodies: none detected in the 12- and 24-week oral studies.[8]
All of this comes from oral or IV use. No study measured side effects of injection under the skin.
AOD-9604 peptide dosage chart (concentration only)
With no tested injectable dose, this chart shows only what one syringe unit holds. At 1,815.1 g/mol, 100 mcg is 55.1 nmol.
| Vial + liquid | mg/mL | mcg per unit | nmol per unit | Units per 100 mcg |
|---|---|---|---|---|
| 2 mg + 1 mL | 2 | 20 | 11.02 | 5 |
| 2 mg + 2 mL | 1 | 10 | 5.51 | 10 |
| 2 mg + 3 mL | 0.667 | 6.67 | 3.67 | 15 |
| 5 mg + 1 mL | 5 | 50 | 27.55 | 2 |
| 5 mg + 2 mL | 2.5 | 25 | 13.77 | 4 |
| 5 mg + 3 mL | 1.667 | 16.67 | 9.18 | 6 |
| 10 mg + 1 mL | 10 | 100 | 55.09 | 1 |
| 10 mg + 2 mL | 5 | 50 | 27.55 | 2 |
| 10 mg + 3 mL | 3.333 | 33.33 | 18.36 | 3 |
Example arithmetic: a 5 mg vial with 2 mL holds 25 mcg per unit, so 250 mcg is 10 units. The formulas are on the how to reconstitute peptides page.
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
- CJC-1295 / ipamorelinNot approved Two growth-hormone secretagogues, often sold together. Both rejected for compounding in 2024.
- SermorelinDiscontinued Once sold as Geref. Discontinued in 2008, not for safety reasons.
- GHRP-6Not approved Growth hormone-releasing hexapeptide. On FDA 503B Category 2.
- HexarelinNot approved GHRP-6 plus one methyl group. Studied in the 1990s, never approved.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
Frequently asked questions
What is the AOD-9604 dosage?
Does AOD-9604 work for weight loss?
The FDA concluded that in most studies it "failed to show benefit for weight reduction when compared to placebo", and the developer ended obesity development in 2007.[4]
Is AOD-9604 FDA-approved?
No, and an FDA advisory committee voted 0–12 against adding it to the compounding list in 2024.[5]
Is AOD-9604 banned in sport?
Yes. WADA 2026 names it under S2.2.3 as a growth hormone fragment, prohibited at all times.[12]
Sources
- openFDA Drugs@FDA searches for AOD-9604, KPV, epitalon, semax, selank, cagrilintide, melanotan and NAD (no application found)
- Certain bulk drug substances for use in compounding that may present significant safety risks
- Bulk drug substances nominated for use in compounding under section 503A (category lists)
- FDA briefing document: AOD-9604-related bulk drug substances
- Pharmacy Compounding Advisory Committee, December 4, 2024: final summary minutes
- Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (91 FR 68526)
- GRAS Notice Inventory (no AOD-9604 notice)
- Stier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans (J Endocrinol Metab 2013;3:7–15)
- Warning letter: Tailor Made Compounding LLC
- Warning letter: Innoveix Pharmaceuticals Inc
- Poisons Standard June 2026 (SUSMP No. 48): Schedule 4 and Appendix D entries for AOD-9604
- World Anti-Doping Code: Prohibited List 2026
- Athlete advisory: what's new on the 2027 WADA Prohibited List
- PubChem CID 71300630: AOD-9604