AOD-9604

Areas of active research — not promised effects

Each tag links to other compounds with research into that goal. Research use only: these are areas of study, not human-use claims.

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AOD-9604 has no FDA approval as a finished drug product. It was listed in FDA's Category 2 of the 503A bulk drug substances interim list (substances presenting potential significant safety risks), which restricts its use in compounding pharmacies. As of April 2026, AOD-9604 was NOT among the 12 peptides removed from Category 2 (those were BPC-157, TB-500, KPV, MOTs-C, Epitalon, Semax, DSIP, GHK-Cu, Melanotan II, LL-37, DiHexa, and PEG-MGF). AOD-9604 remains on the Category 2 list. A separate civil lawsuit (Evexias/Farmakeio) was filed challenging FDA's Category 2 placement; FDA agreed to accelerate review of AOD-9604, CJC-1295, ipamorelin acetate, and thymosin alpha-1 in response. As of May 2026, no formal reclassification has occurred. Availability is therefore restricted to legitimate research use only (RUO), not for clinical compounding or human administration.

Confirmed high-severity market-integrity event (enforcement / recall / counterfeit)

Transparent blend · bci-1.0 · never paid-placement

Primary name

AOD-9604

Origin

AOD-9604 (Anti-Obesity Drug 9604) was rationally designed in the 1990s by researchers at Monash University (Melbourne, Australia) led by Professor Frank Ng. It corresponds to residues 176–191 of the 191-amino-acid human growth hormone sequence, modified at the N-terminus with a tyrosine addition to improve stability. The rationale was to isolate the region of hGH responsible for lipolytic activity and deliver those metabolic effects without the somatogenic, insulin-resistance, and IGF-1-elevating effects of full-length hGH. It carries CAS 221231-10-3, DrugBank DB06388, and PubChem CID 71300630. Development as an anti-obesity drug candidate (branded 'Metabolvos' by Metabolic Pharmaceuticals) was discontinued after a Phase 2b obesity trial (536 subjects, 24 weeks) failed to meet its primary weight-loss endpoint versus placebo circa 2007. No regulatory authority has approved AOD-9604 as a therapeutic product.

Registry IDs

PubChem CID

71300630

CAS

221231-10-3

InChIKey

GVIYUKXRXPXMQM-BPXGDYAESA-N

DrugBank

DB06388

Molecular formula

C78H123N23O23S2

Molar mass

1815.1 g/mol

Monoisotopic

1813.86035961 Da

InChIKey

GVIYUKXRXPXMQM-BPXGDYAESA-N

Appearance

White to off-white lyophilized powder

Solubility

Soluble in water and dilute acetic acid (0.1–1% acetic acid); limited solubility…

Sequence not available in current seed.

Stability: The disulfide bond (Cys-Cys bridging positions in the cyclic region) is susceptible to oxidative degradation; reducing agents in reconstitution buffers should b

Vial sizes

2 mg · 5 mg

Purity grades

≥98% HPLC

Salt forms

Free base (primary)

• GHS hazard class on file
• PPE & spill response
• Disposal guidance
• Not-for-human-consumption posture

How much research exists, and of what maturity — never a verdict on whether it works.

Mechanism of action

• AOD-9604 is proposed to stimulate lipolysis in adipocytes via beta-3 adrenergic receptor agonism, mimicking the fat-mobilizing activity attributed to the C-terminal region of hGH
• In vitro studies with isolated rodent adipocytes demonstrated increased fatty-acid oxidation and concurrent inhibition of lipogenesis (de novo fatty acid synthesis), a dual action distinct from agents that stimulate only fat breakdown
• Critically, the peptide does not appear to bind the canonical growth hormone receptor and does not elevate circulating IGF-1 or promote somatogenic growth in the rodent models studied
• This receptor selectivity is the basis for the hypothesis that the lipolytic activity of hGH can be dissociated from its growth-promoting side-effect profile

Pharmacokinetics (ADME)

Half-life

Approximately 30–60 minutes (plasma; estimated from human safety studies); formally characterized half-life not published in peer-reviewed literature

Clearance

Rapid proteolytic clearance; no significant tissue depot effect reported; route of elimination not formally characterized

PK–PD note: In clinical safety studies conducted by Metabolic Pharmaceuticals (approx. 900 subjects across six trials), both subcutaneous/intravenous single doses (25–400 mcg/kg) and oral doses (1–30 mg/day over …

Reading the evidence

• Evidence quality and gaps vary by application — see the cited grades above.
• Indexed-article counts span all evidence tiers, not only completed human trials.
• No first-party human-dosing, efficacy, or benefit claims are made here.

Key reviews & evidence-gap sources

• Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004 Apr;5(4):436-40. (Review; notes Phase IIa trials underway by Feb 2002)
• Valentino MA, Lin JE, Waldman SA. Central and Peripheral Molecular Targets for Anti-Obesity Pharmacotherapy. Clin Pharmacol Ther. 2010 Jun;87(6):652-662. (Review citing 12-week RCT: 1 mg/d AOD-9604 lost 2.6 kg vs 0.8 kg placebo; not dose-dependent)
• Obesity Pharmacotherapy: Current Perspectives and Future Directions (PMC review)
• Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026 Apr 12. (Review)
• Rahman OF, Lee SJ, Seeds WA. Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions. J Am Acad Orthop Surg Glob Res Rev. 2026;10(1):e25.00236. (Review)
• Dominikowski A, et al. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis. Front Endocrinol. 2026;17:1822475. (Review)
• Heffernan MA, et al. Effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism in obese mice and beta(3)-AR knock-out mice. (Primary mechanistic/animal study)

No registered human trials found for this compound.

Status

No registered trials found

Summary (literature)

In clinical safety studies totaling approximately 900 participants conducted by Metabolic Pharmaceuticals, AOD-9604 was reported to be generally well tolerated across both subcutaneous and oral routes, with no serious adverse events attributed to the peptide. Transient injection-…

WADA status

Prohibited at all times (in- and out-of-competition) under the WADA Prohibited List, classified as a growth hormone fragment under Section S2 (Peptide Hormones,…

Dominant research route: Oral

Human Phase 2b obesity RCTs (oral capsules) plus chronic oral gavage toxicology in rats (6 months) and cynomolgus monkeys (9 months); oral PK in pigs; oral dosing in obese Zucker rats

Bioavailability: Orally administered AOD9604 in pigs was well absorbed with rapid degradation kinetics; rat whole-body radiography showed similar organ distribution after IV or oral application; oral kinetics slower than IV but same N-terminal degradants (-2aa, -3aa) observed

Dominant route of the human clinical program: METAOD005 (12-week oral 1-30 mg/day in ~300 obese adults) and METAOD006/OPTIONS (24-week oral 0.25, 0.5, or 1 mg/day in ~502 obese adults; primary endpoint not met). Chronic oral gavage safety studies in rats and monkeys showed no toxicological concerns.

Human single-dose IV studies (25-400 mcg/kg) per regulatory/secondary summaries; animal IV PK in pigs, 14C-radiography in rats, 4-week rat IV toxicity with micronucleus assay

Bioavailability: Very short circulating half-life (~3-4 minutes) after IV dosing; rapid sequential N-terminal degradation with -2aa and -3aa principal fragments; AOD9604 and degradants appeared rapidly in IV-dosed pigs

IV used in early human single-dose tolerability/PK studies and in non-clinical PK and toxicology (rats, pigs); not a route used in the pivotal Phase 2b efficacy trials, which were oral.

No published human pharmacokinetic or efficacy data; cited as the most common contemporary community/research-context injectable format

Bioavailability: No human PK characterization; FDA's December 2024 PCAC review specifically flagged absence of published human exposure data for the subcutaneous route offered by compounders

FDA reviewers reported no human information for proposed subcutaneous use; current SC use derives from community/research-planning practice rather than controlled human trials. Injectable SC uses lower doses than oral trials due to presumed higher bioavailability, but this is not formally characterized in humans.

No published human exposure data; referenced only as a compounding-offered route in FDA's December 2024 PCAC review

Bioavailability: No human PK or efficacy data; FDA review identified compounded transdermal AOD-9604 products without supporting human exposure information

FDA's December 2024 PCAC briefing document discusses compounded products containing AOD-9604 (free base) or AOD-9604 acetate administered by subcutaneous or transdermal routes in humans, but reviewers found no supporting human data.

No published human exposure data; listed among compounding-offered routes flagged by FDA reviewers

Bioavailability: No human PK or efficacy data available

FDA's 2024 review reportedly flagged absence of published human exposure data for intranasal route offered by compounding pharmacies; no controlled human intranasal study identified.

Animal & human figures are kept visibly separate so studied animal doses are never misread as human guidance.

Sorted A–Z by vendor — never by price

Weekly median $/mg from the live vendor crawl.

Researched storefront prices, bucketed

p25 $5.43 · median $9.00 · p75 $10.14 · 7 researched vendors

Legit, COA-backed band: $6.30–$12.00/mg.

Value rule: don't just buy the cheapest — a price under $3/mg is a red flag. Pair price with COA and independent-test grade.

Estimated cost of research (10 mg)

Vial (best researched price)

$28

Bacteriostatic water (generic estimate)

$6

Syringes / supplies (generic estimate)

$12

What each test proves — general guidance, plus this compound's researched purity data

Purity on the current market (researched)

Independent (Janoshik Analytical) HPLC reports for research-grade AOD-9604 cite ~99.84% purity; vendor-published third-party COAs commonly claim 98–99%+.

Independent labs cited for this compound

One compound-specific recall located: Innoveix Pharmaceuticals' July 9, 2021 voluntary recall of compounded AOD-9604 3 mg for lack of sterility assurance. No other AOD-9604-specific recalls found in FDA enforcement records.

Buyer red-flag checklist

• AOD-9604 has never received FDA approval for any indication.
• FDA has proposed not including AOD-9604 on the 503A bulk drug substances list, citing immunogenicity risk and insufficient safety data.
• WADA classifies AOD-9604 as a banned substance (not approved for therapeutic use by any government health authority).
• Compounded AOD-9604 was subject to a sterility-assurance recall (Innoveix, 2021) and an associated FDA warning letter for insanitary conditions.
• AOD-9604 has been identified in counterfeit/seized pharmaceutical preparations (Belgian authorities, 2014).
• FDA briefing documents note CoA discrepancies for nominated AOD-9604 bulk substance (free base vs acetate; CAS/molecular-formula mismatches).
• AOD-9604 tends to gel in ultra-pure water, complicating accurate analytical quantitation and potentially affecting purity/weight measurements.
• Research-grade AOD-9604 is sold as 'research use only / not for human consumption' yet is widely marketed for human use, mirroring prior criminal distribution patterns (e.g., 2013 DEA case against an Illinois distributor of China-sourced peptides).

GMP vs research-grade: the chemistry (SPPS + HPLC + MS) is identical — the difference is the quality system.

Underdosing / mislabeling: A single published Janoshik batch ledger reports AOD-9604 5.27 mg in a 6 mg-labeled vial (~88% of label claim, ~12% under) at 99.839% purity; no aggregated independent-lab prevalence dataset is available, so a prevalence figure is not asserted.

• An RUO label is not an import exemption — CBP judges actual intended use.
• Lyophilized powder is ambient-stable in transit; temperature control needed for > 7-day transit.
• US-warehouse vendors dodge import scrutiny — they cost more but ship more reliably.

Every item dated & sourced

Prohibited — listed under S2 (Peptide Hormones, Growth Factors and Related Substances) as a growth hormone fragment, e.g. AOD-9604 and hGH 176-191; historically treated as banned under S0 (unapproved substances) since 2011.

No granted patents identified in current seed. Composition-of-matter coverage is limited given the peptide's synthetic origin.

• IACUC / IRB research context
• RUO buyer responsibilities & documentation
• Veterinary / alternative-use where lawful
• Jurisdiction-aware "who may lawfully obtain"

What people discuss

Reported concerns — discussion, not established effects

Reading caveats

• self-experimentation survivorship bias
• vendor-affiliated forum posters and protocol authors
• stacking confounds (results attributed to AOD while co-administered with GLP-1/GH secretagogues)
• small-n anecdote dominance over controlled trial data
• MPMD/YouTube influencer amplification

Manually researched from reddit, youtube— theme weights are research estimates, not live counts; aggregated & de-identified. No individual posts, quotes, or usernames are ever shown.

Relative research / market volume — populated once the activity stream is wired

Inline tooltips for lyophilized, RUO, EU/mg, SPPS, 503A and more.

Toggle plain-language ↔ scientific in the header.

• How to read a COA
• Free base vs acetate
• Understanding evidence grades

Synthetic 16-amino-acid C-terminal fragment of hGH (residues 176–191) studied in animal models and early human trials for fat metabolism and adipose lipolysis. Approximately 16 articles are indexed (literature last scanned 2026-05-29). US regulatory status: Category 2 bulk drug substance (503A); not approved; RUO only. Research use only.

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