{"format":"citation-manifest/v1","page":"https://aod9604co.com/monograph","claim_count":61,"claims":[{"id":"AOD-001","text":"AOD-9604 is a synthetic hexadecapeptide consisting of the C-terminal fragment of human growth hormone, residues 177-191, with an additional tyrosine at the N-terminus; sequence YLRIVQCRSVEGSCGF with the two cysteines linked by a disulfide bond; PubChem CID 71300630, molecular formula C78H123N23O23S2, molecular weight 1815.1, UNII 7UP768IP4M.","source_url":"https://europepmc.org/article/MED/25208511","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"AOD-002","text":"The compound circulates under two numbering conventions. Counting the added tyrosine it is called hGH fragment 176-191; counting only the native growth hormone residues it is hGH 177-191. WADA's 2026 Prohibited List names both forms.","source_url":"https://www.wada-ama.org/en/prohibited-list","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-003","text":"AOD-9604 is a growth hormone fragment, not a growth hormone secretagogue: it does not act by making the pituitary release growth hormone, and it acts independently of the growth hormone receptor.","source_url":"https://europepmc.org/article/MED/11673763","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"AOD-004","text":"The same molecule was later developed under the code LAT8881 by Lateral Pharma, which is how three further human trials of this peptide came to exist under a different name.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10034483/","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-010","text":"No drug product containing AOD-9604 has ever been approved by FDA for any use. An openFDA Drugs@FDA query for the active ingredient returns NOT_FOUND.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-011","text":"AOD-9604 appears on FDA's compounding safety-risks page in the table of bulk drug substances nominated but withdrawn, meaning the nomination to allow compounding with it was pulled by the nominator rather than resolved in its favour.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-012","text":"FDA states that 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; that FDA has identified no, or only limited, safety-related information; that the agency therefore lacks sufficient information to know whether the drug would cause harm when administered to humans; and that FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-013","text":"AOD-9604 was developed by Metabolic Pharmaceuticals Ltd of Australia as an anti-obesity candidate, with phase 2a trials underway by February 2002.","source_url":"https://europepmc.org/article/MED/15134286","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-014","text":"By contrast, growth hormone itself has 12 approved applications containing somatropin in FDA's Drugs@FDA database.","source_url":"https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22somatropin%22&limit=1","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-015","text":"Compounded drugs are not FDA-approved products: FDA does not verify their safety, effectiveness or quality before marketing.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-019","text":"Six randomized, double-blind, placebo-controlled trials of AOD-9604 were performed in the obesity program, coded METAOD001 through METAOD006, with approximately 900 adult subjects in total, approved by independent ethics committees of up to 16 Australian hospitals and medical centers.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-trial","grade_label":"Human trial"},{"id":"AOD-020","text":"The four early trials tested single or one-week dosing: METAOD001 was a phase 1 dose escalation of 25 to 400 mcg/kg intravenously in 15 healthy males with recombinant hGH as a positive control; METAOD002 gave single intravenous doses of 25, 50 and 100 mcg/kg to 23 obese males; METAOD003 gave single oral doses of 9, 27 and 54 mg to 17 obese males; METAOD004 gave 9, 27 or 54 mg orally daily for seven days to 36 obese males.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-trial","grade_label":"Human trial"},{"id":"AOD-021","text":"In the phase 1 study, no significant glycerol, glucose or IGF-1 trends were observed for AOD9604, recombinant hGH or placebo, and no serious adverse events occurred; 29 adverse events were reported by 12 subjects, most commonly headache.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-trial","grade_label":"Human trial"},{"id":"AOD-022","text":"In the oral single-dose study no significant IGF-1 changes occurred at any dose; glucose was unchanged apart from one isolated 8 percent increase 12 hours after dosing in one subject receiving 54 mg; and the only event deemed definitely treatment-related in that study followed placebo, not drug.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-trial","grade_label":"Human trial"},{"id":"AOD-023","text":"METAOD005 randomized 300 healthy obese adults with a BMI at or above 35 across five Australian hospitals to 12 weeks of daily oral AOD9604 at 1, 5, 10, 20 or 30 mg or placebo, about 50 per group, after a 2-week single-blind placebo run-in. Its stated objective included efficacy measured as reduction in body weight.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-024","text":"No weight-loss result for METAOD005 has ever been published. The peer-reviewed paper covering that trial reports its safety and tolerability findings and does not report the efficacy endpoint the trial was designed to measure.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"AOD-025","text":"Five serious adverse events were reported in METAOD005, all neoplasms and all in AOD9604 arms: three in the 20 mg group (basal cell carcinoma, moderate lipoma and squamous cell carcinoma), one in the 5 mg group (breast cancer) and one in the 10 mg group (malignant melanoma). According to the investigator, none were considered possibly, probably or definitely related to study medication, and IGF-1 did not change, so they could not be attributed to raised IGF-1.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-026","text":"The pivotal trial, METAOD006, randomized 502 of 534 enrolled clinically obese adults at 16 Australian hospitals and medical centres to 24 weeks of daily oral AOD9604 at 0.25, 0.5 or 1 mg or placebo, and it failed to demonstrate a significant benefit on the primary weight-loss endpoint.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-027","text":"The obesity program was terminated. The primary record of that decision is a 2007 sponsor announcement to the Australian Securities Exchange titled to the effect that the phase 2B trial results do not support commercial viability of the obesity project and that the programme is terminated.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-028","text":"No human trial of AOD-9604 has found a significant IGF-1 change. In the 24-week trial the overall mean IGF-1 changes were 1.76 nmol/L at 12 weeks and 1.24 nmol/L at 24 weeks, with no statistically significant differences between treatment groups or placebo (p = 0.50844 after 12 weeks and p = 0.75754 after 24 weeks), and no anti-AOD9604 antibodies were detected in the subset of patients assayed.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-029","text":"Tolerability in the 24-week trial was indistinguishable from placebo, with adverse events in 78.7 percent of subjects overall and an incidence range of 75.6 to 83.2 percent across arms, the highest being the placebo group; no adverse event was deemed definitely related to study treatment.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-030","text":"The same peptide was taken into three further human trials under the name LAT8881 by Lateral Pharma, in neuropathic pain (53 participants), acute migraine (21) and lumbar radicular pain (26). All three are completed with results posted on ClinicalTrials.gov.","source_url":"https://clinicaltrials.gov/study/NCT03865953","grade":"registry","grade_label":"Registry record"},{"id":"AOD-031","text":"In the neuropathic pain trial the primary endpoint, absolute change in mean pain score on an 11-point numeric pain rating scale, was -0.87 (SD 1.53) on LAT8881 versus -0.74 (SD 2.09) on placebo.","source_url":"https://clinicaltrials.gov/study/NCT03865953","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-032","text":"In the acute migraine trial the primary endpoint, change in migraine headache pain score on an 11-point numeric rating scale, was 0 (SD 1.10) on active drug versus 0.2 (SD 1.33) on placebo.","source_url":"https://clinicaltrials.gov/study/NCT04153409","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-033","text":"In the lumbar radicular pain trial, the Part B primary endpoint, change in baseline pain, was 3.7 (SD 2.7) on intravenous LAT8881 versus 3.1 (SD 2.3) on placebo, with Part A testing single intravenous infusions of 0.8, 1.2 and 1.8 mg/kg.","source_url":"https://clinicaltrials.gov/study/NCT05298306","grade":"human-rct","grade_label":"Human RCT"},{"id":"AOD-034","text":"The only human pharmacokinetic data posted for this peptide come from that 2023 intravenous study: mean Cmax 12.6, 10.2 and 13.8 ng/mL at 0.8, 1.2 and 1.8 mg/kg, Tmax 0.08 hours at every dose, and a terminal half-life that could not be determined at any dose because the criterion of at least three quantifiable elimination-phase data points was not met.","source_url":"https://clinicaltrials.gov/study/NCT05298306","grade":"human-pk","grade_label":"Human PK"},{"id":"AOD-035","text":"No human study of this molecule has used the subcutaneous route. The obesity trials used intravenous infusion or oral capsules and tablets; the later pain trials used oral capsules or intravenous infusion. The subcutaneous injectable sold today has no human pharmacokinetic or efficacy data behind that route.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"AOD-036","text":"The doses circulating in bodybuilding forums, documented in the peer-reviewed review literature, are 250 to 500 mcg per day subcutaneously in 2 to 3 injections, typically cycled 8 to 12 weeks, against studied human doses of 25 to 400 mcg/kg intravenously as single administrations and 1 mg orally once daily for 12 weeks.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-040","text":"In obese Zucker rats, 500 mcg/kg of AOD9604 given orally daily for 19 days reduced body weight gain by over 50 percent versus control, 15.8 +/- 0.6 g against 35.6 +/- 0.8 g, with increased lipolytic activity in adipose tissue.","source_url":"https://europepmc.org/article/MED/11146367","grade":"animal","grade_label":"Animal"},{"id":"AOD-041","text":"In the same rat study, unlike chronic treatment with intact hGH, chronic AOD9604 showed no adverse effect on insulin sensitivity as demonstrated with euglycemic clamp techniques.","source_url":"https://europepmc.org/article/MED/11146367","grade":"animal","grade_label":"Animal"},{"id":"AOD-042","text":"The claim that this fragment separates fat metabolism from growth hormone signalling rests on a 2001 mouse and cell study: both hGH and AOD9604 reduced body weight gain in obese mice with increased fat oxidation and plasma glycerol, but AOD9604 did not induce hyperglycaemia or reduce insulin secretion, did not compete for the hGH receptor, and did not induce cell proliferation.","source_url":"https://europepmc.org/article/MED/11673763","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"AOD-043","text":"The authors of that study framed their result as evidence that growth hormone behaves as a pro-hormone and that its fragments can act in ways novel to traditional growth-hormone-stimulated pathways.","source_url":"https://europepmc.org/article/MED/11673763","grade":"animal-and-in-vitro","grade_label":"Animal and in vitro"},{"id":"AOD-044","text":"A companion 2001 study found that hGH and AOD9604 raised repressed beta3-adrenergic receptor RNA in obese mice toward lean levels, but that in beta3-AR knock-out mice chronic treatment failed to change body weight or lipolysis, leading the authors to conclude the lipolytic actions are not mediated directly through beta3-AR.","source_url":"https://europepmc.org/article/MED/11713213","grade":"animal","grade_label":"Animal"},{"id":"AOD-045","text":"The only human tissue ever exposed to this compound in a published experiment was isolated adipose tissue in vitro, not a person: the peptide increased in vitro lipolytic activity and decreased lipogenic activity in isolated adipose tissue from obese rodents and humans.","source_url":"https://europepmc.org/article/MED/10950816","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-046","text":"In the 30-day oral mouse study, body weight gain in treated animals was significantly lower than saline controls from day 16 onward, with no difference in food consumption between groups, which is the basis for describing the effect as metabolic rather than appetite-mediated.","source_url":"https://europepmc.org/article/MED/10950816","grade":"animal","grade_label":"Animal"},{"id":"AOD-047","text":"In obese Zucker fatty rats treated for 20 days with the un-tyrosinated parent fragment, mean adipocyte diameter fell from 110 to 80 micrometres, with stimulation of hormone-sensitive lipase and inhibition of acetyl-CoA carboxylase and no induced insulin resistance or glucose intolerance.","source_url":"https://europepmc.org/article/MED/11116208","grade":"animal","grade_label":"Animal"},{"id":"AOD-048","text":"Long-term treatment of obese mice with synthetic hGH 177-191 reduced cumulative body weight gain and decreased adipose tissue mass, with lipogenesis in adipose tissue significantly inhibited.","source_url":"https://europepmc.org/article/MED/7987248","grade":"animal","grade_label":"Animal"},{"id":"AOD-049","text":"A 1993 study of the same C-terminal sequence found antilipogenic activity identical to intact hGH but no significant lipolytic effect as measured by glycerol release from epididymal fat pads, concluding that the main physiological effect of hGH on lipid metabolism is at the level of lipogenesis.","source_url":"https://europepmc.org/article/MED/8358331","grade":"animal","grade_label":"Animal"},{"id":"AOD-050","text":"In isolated adipocytes from obese Zucker rats the fragment reduced basal and insulin-stimulated deoxyglucose uptake and, at equimolar concentrations, was more potent than intact hGH in doing so.","source_url":"https://europepmc.org/article/MED/8118430","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-051","text":"In 1982, the same C-terminal region was reported to be insulin-antagonistic: Cam-hGH 177-191 caused significant hyperglycaemia and insulin resistance in normal rats at nanomolar quantities, with the active core located within residues 178 to 190.","source_url":"https://europepmc.org/article/MED/6751009","grade":"animal","grade_label":"Animal"},{"id":"AOD-052","text":"The cyclic 15-residue peptide's solution structure was solved by two-dimensional proton NMR, showing type I beta-turns in the cyclic region and retained structural similarity to the corresponding region of the intact hGH crystal structure.","source_url":"https://europepmc.org/article/MED/11152298","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-053","text":"The joint-repair literature for this compound is one rabbit study: 32 New Zealand white rabbits with collagenase-induced knee osteoarthritis received weekly ultrasound-guided intra-articular injections of saline, 6 mg hyaluronic acid, 0.25 mg AOD9604, or both, and the combination group scored better on cartilage measures than either agent alone and had the shortest lameness period.","source_url":"https://europepmc.org/article/MED/26275694","grade":"animal","grade_label":"Animal"},{"id":"AOD-054","text":"That rabbit study delivered the compound by ultrasound-guided injection directly into the joint capsule, a route and target that no subcutaneous injection reproduces.","source_url":"https://europepmc.org/article/MED/26275694","grade":"animal","grade_label":"Animal"},{"id":"AOD-055","text":"A 2026 peer-reviewed review states that claims around osteoarthritis, joint repair or tissue regeneration are currently grounded mainly in animal work, with a lack of convincing human clinical trial evidence in these indications.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-056","text":"The same review places AOD9604 in an intermediate evidence tier, describing it as a tier-B/C agent for which short-term human trials exist but with limited interpretable signals, and states that there are no robust data supporting clinically meaningful visceral-fat reduction or broader metabolic benefit in humans.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-060","text":"In pigs, AOD9604 had a very short half-life of approximately 3 minutes after intravenous injection, with almost all of it cleared from blood plasma by 12 minutes; in rat plasma in vitro the serum half-life was approximately 4 minutes, with intact peptide undetectable 56 minutes after spiking. The same paper cites a plasma half-life of about 21 minutes for regular hGH.","source_url":"https://www.jofem.org/index.php/jofem/article/view/213","grade":"animal-pk","grade_label":"Animal PK"},{"id":"AOD-061","text":"The peptide is orally bioavailable in animals: after oral administration, mass-spectrometric and immunoassay analysis showed AOD9604 and its degradation fragments appearing in pig plasma, with more protracted absorption than after intravenous injection.","source_url":"https://www.jofem.org/index.php/jofem/article/view/213","grade":"animal-pk","grade_label":"Animal PK"},{"id":"AOD-062","text":"Non-clinical toxicology found no genotoxicity in the Ames test, a CHO chromosomal aberration assay or a rat bone micronucleus assay, and no toxicological concerns after 6 months of daily oral gavage in rats and 9 months in cynomolgus monkeys.","source_url":"https://www.jofem.org/index.php/jofem/article/view/213","grade":"animal","grade_label":"Animal"},{"id":"AOD-063","text":"The sponsor's own 2014 paper describes AOD9604 as a nutraceutical ingredient and records that it had been determined by a qualified expert panel to be Generally Recognized As Safe under conditions of intended use in foods, an afterlife route pursued after the drug program ended.","source_url":"https://www.jofem.org/index.php/jofem/article/view/213","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-070","text":"AOD9604 is degraded by sequential removal of amino acids from the N-terminus. Six potential metabolites were identified after incubation in serum and urine, and one, the peptide CRSVEGSCG, is significantly more stable than the other metabolites or the parent compound.","source_url":"https://europepmc.org/article/MED/25208511","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-071","text":"A validated urinary assay detects AOD9604 down to 50 pg/mL with 62 percent recovery, and the paper reporting it records that the peptide is available on several internet websites and was recently identified in confiscated vials in the USA.","source_url":"https://europepmc.org/article/MED/25208511","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-072","text":"AOD9604 has been identified by government analysts in unlabelled pharmaceutical preparations seized by Belgian authorities, published as a case report.","source_url":"https://europepmc.org/article/MED/24976118","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-073","text":"AOD-9604 does not influence the WADA hGH isoform immunoassay, which is why anti-doping laboratories developed dedicated peptide assays for it rather than relying on growth hormone testing.","source_url":"https://europepmc.org/article/MED/24124033","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-074","text":"In doping-control matrices, AOD9604 degrades quickly in liquid samples: at 4 and 22 degrees Celsius it was extensively degraded after one week in serum and plasma, while remaining detectable in dried matrices throughout a two-month study.","source_url":"https://europepmc.org/article/MED/42328738","grade":"in-vitro","grade_label":"In vitro"},{"id":"AOD-075","text":"AOD-9604 is prohibited at all times in sport. The 2026 WADA Prohibited List names it explicitly under section S2.2.3, growth hormone fragments.","source_url":"https://www.wada-ama.org/en/prohibited-list","grade":"regulatory","grade_label":"Regulatory record"},{"id":"AOD-076","text":"Peer-reviewed reviews record AOD-9604 as one of the unapproved peptides marketed direct to patients in sports medicine and orthopaedics, in a market where rigorous human safety data are scarce and there is potential for serious harm to patients.","source_url":"https://europepmc.org/article/MED/41966639","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-077","text":"AOD-9604 was tracked in the obesity-drug development literature of the 2000s as a human growth hormone fragment that increases adipose tissue breakdown, alongside candidates such as rimonabant, cetilistat and oleoyl-estrone.","source_url":"https://europepmc.org/article/MED/16625817","grade":"review","grade_label":"Review or guideline"},{"id":"AOD-090","text":"There is no ClinicalTrials.gov record for AOD9604 under that name: an API query for the term returns zero studies. The three registered human trials of this molecule are registered under the later development code LAT8881.","source_url":"https://clinicaltrials.gov/search?term=AOD9604","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"AOD-091","text":"No human trial of AOD-9604 has ever reported a positive efficacy result for any indication. Across nine human trials with published or posted outcomes, the results are: safety endpoints met, one failed weight-loss endpoint, one unpublished weight-loss endpoint, and three pain trials whose posted primary results did not separate from placebo.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"absence-of-evidence","grade_label":"Absence of evidence"},{"id":"AOD-092","text":"This pack's own evidence table holds 25 study rows, each labelled by species; 9 are human, and none of the human rows reports a positive result for the fat-loss, muscle, recovery or anti-aging outcomes this compound is sold for.","source_url":"https://www.jofem.org/index.php/jofem/article/view/157","grade":"internal-measurement","grade_label":"Internal measurement"},{"id":"AOD-093","text":"This pack cites 37 distinct sources, every one of them peer-reviewed literature, a government page or a trial registry record, and every primary link resolved at fetch time.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"internal-measurement","grade_label":"Internal measurement"}]}