Section 1 of 12Overview
Overview
AOD-9604 is a synthetic 16-amino-acid growth-hormone fragment analog. It was developed for obesity, where its pivotal trial did not show significant weight loss versus placebo. That obesity program ended in 2007. The same molecule was later studied under the code LAT8881 in three completed pain trials, so it is inaccurate to say that all research on the molecule stopped in 2007.
None of those later registered studies reported a statistically significant primary efficacy result. AOD-9604 is not a proven treatment for obesity, pain or joint disease.
No approved clinical use
No FDA-approved drug or centrally EU-authorised product containing AOD-9604/LAT8881 was identified. No approved dose exists, and study protocols are not treatment guidance.
Section 2 of 12Verified identity
Verified identity
FDA GSRS identifies AOD-9604 as LAT-8881, UNII 7UP768IP4M. FDA's 2024 briefing gives the free-base formula C78H123N23O23S2, molecular weight 1815.09 g/mol, and the sequence:
YLRIVQCRSVEGSCGF
The peptide contains a disulfide bond between Cys7 and Cys14. It can be described exactly as Tyr-hGH(177-191) or equivalently [F176Y]hGH(176-191). Both AOD-9604 and native hGH 176-191 are 16-mers; AOD is not a 17-residue peptide made by simply adding tyrosine to the intact native 16-mer.
Section 3 of 12Preclinical mechanism evidence
Preclinical mechanism evidence
Rodent studies reported increased lipolysis and fat oxidation and reduced weight gain or body weight in obese animals. A beta-3 adrenergic receptor knockout study found that chronic weight and lipolysis effects were lost in knockout mice, while some acute energy-expenditure and fat-oxidation effects remained. The mechanism was therefore not purely beta-3 dependent.
These findings provide an animal hypothesis, not a demonstrated human weight-loss mechanism. Positive rodent results must be read together with the negative pivotal human obesity trial.
Section 4 of 12Human obesity program
Human obesity program
FDA reconstructed the development program from sponsor-linked reports and company filings because a full pivotal methods-and-results article was not located. In the OPTIONS/METAOD006 study, 536 adults were enrolled and 502 randomized to oral AOD-9604 or placebo alongside a diet-and-exercise program for 24 weeks. The primary weight endpoint was assessed at 12 weeks.
Weight loss did not differ significantly between AOD-9604 and placebo at the primary endpoint. The company also reported no statistically significant difference at 24 weeks and ended development for obesity in February 2007.
The human exposure summarized across six sponsor-funded trials is useful for safety review, but the 2013 retrospective article is sponsor-linked and is not a substitute for a prospectively published pivotal efficacy report.
Section 5 of 12Later LAT8881 clinical studies
Later LAT8881 clinical studies
ClinicalTrials.gov contains three completed later studies of the same molecule under the code LAT8881:
| Study | Population | Primary result |
|---|---|---|
| NCT03865953 | Neuropathic pain, n=53 | Pain change −0.87 vs −0.74; difference −0.14 (95% CI −0.76 to 0.49), p=0.67 |
| NCT04153409 | Acute migraine, n=21 | No listed time comparison was significant; at 2 hours difference −0.89 (95% CI −2.11 to 0.32), p=0.1488 |
| NCT05298306 | Lumbar radicular pain, n=26 | Resting-pain endpoint was not significant; at 1 hour difference −0.21 (95% CI −0.97 to 0.56), p=0.5903 |
The last study reported an exploratory signal for provoked pain, but that was not the primary resting-pain outcome. The bounded registry search found these three completed LAT8881 records and no active registered study.
Section 6 of 12Cartilage and joint claims
Cartilage and joint claims
A rabbit osteoarthritis model reported cartilage-related findings after intra-articular AOD-9604, including in combination with hyaluronic acid. This is animal evidence. FDA's own search found no clinical AOD-9604 study in osteoarthritis or osteoporosis populations.
Claims that AOD-9604 “rebuilds cartilage” in people therefore go beyond the evidence. No controlled human cartilage-regeneration result was identified.
Section 7 of 12Safety and pharmacokinetic limits
Safety and pharmacokinetic limits
FDA found no human pharmacokinetic or pharmacodynamic study for any route, no human subcutaneous or transdermal exposure data, and insufficient information to support long-term safety in obesity. Reported adverse events included diarrhea and possible chest tightness or euphoria; the available reports did not allow FDA to determine relatedness for several serious events.
The absence of a signal in a passive-report database does not prove safety. FDA also highlighted possible immunogenicity, aggregation and peptide-related impurity risks, especially where formulation and product characterization are uncertain.
Limited safety evidence
“Generally well tolerated” in sponsor summaries does not establish zero risk, long-term safety, route-specific safety or safety of current compounded and internet-sold products.
Section 8 of 12Product quality and Russian-language evidence
Product quality and Russian-language evidence
Analytical studies have had to identify AOD-9604 in seized or internet-sold material, illustrating that a label alone does not establish product identity or purity. A Russian 2014 mass-spectrometry study tested three products sold as “HGH 176-191.” All were described with the AOD-like Y-start sequence and all contained impurity compounds.
No Russian-origin primary human study of AOD-9604 or native hGH 176-191 was located in the bounded search. Russian rat abstracts and product analyses are not human efficacy evidence, and inconsistent naming makes sequence-level identity especially important.
Section 9 of 12Regulatory status
Regulatory status
FDA states that neither AOD-9604 free base nor AOD-9604 acetate is a component of an FDA-approved drug. In December 2024, the Pharmacy Compounding Advisory Committee voted 0 yes, 12 no, 0 abstentions on adding either substance to the 503A Bulks List. That was an advisory vote in a compounding process, not a drug-approval decision.
A bounded search of the EU Union Register found no AOD-9604, AOD9604, LAT-8881 or LAT8881 product. This supports the narrower conclusion that no centrally EU-authorised product was identified; it is not an exhaustive claim about every national jurisdiction.
Self-affirmed GRAS statements in sponsor literature are not FDA drug approval and do not establish treatment efficacy.
Section 10 of 12Sport status
Sport status
The 2026 WADA Prohibited List names AOD-9604 explicitly under S2.2.3, growth hormone and its analogs and fragments. It is prohibited at all times for athletes subject to the World Anti-Doping Code. Native hGH 176-191 is named separately in the same subsection.
Historical discussion of AOD-9604 under S0 does not replace its current explicit 2026 classification.
Section 11 of 12Relationship to native hGH 176-191
Relationship to native hGH 176-191
| Property | AOD-9604 / LAT8881 | Native hGH 176-191 |
|---|---|---|
| First residue | Tyrosine (Y) | Phenylalanine (F) |
| Sequence | YLRIVQCRSVEGSCGF | FLRIVQCRSVEGSCGF |
| Formula | C78H123N23O23S2 | C78H123N23O22S2 |
| Mass | 1815.09–1815.1 g/mol | 1799.1 g/mol |
| Human evidence located | Obesity program plus three later LAT8881 trials | None |
They are close analogs, not interchangeable names. AOD/LAT8881 human results cannot be transferred to the native fragment, and native-fragment animal results cannot be treated as AOD clinical evidence.
Section 12 of 12What the evidence supports
What the evidence supports
- Verified identity: AOD-9604/LAT8881 is the Y-start 16-mer
YLRIVQCRSVEGSCGF. - Negative obesity endpoint: the pivotal program did not demonstrate significant weight loss versus placebo and ended for that indication in 2007.
- Later development: three completed LAT8881 pain studies exist; none reported a statistically significant primary efficacy result.
- Preclinical only: lipid-metabolism and cartilage findings are primarily animal evidence.
- Unknowns: human PK/PD, long-term safety, subcutaneous and transdermal human safety remain unestablished.
- Regulatory: no FDA-approved drug or centrally EU-authorised product was identified; the PCAC vote was advisory.
- Sport: AOD-9604 is prohibited at all times under WADA S2.2.3 in 2026.
This article summarizes research and regulatory records for educational purposes. It is not medical advice and does not recommend obtaining or using AOD-9604.