AOD-9604 Research Overview: Trial Results, Status, WADA

AOD-9604 is a 16-amino-acid peptide: a fragment of human growth hormone (hGH) with one extra amino acid. It was developed as an obesity drug, tested in six company-run human studies, and abandoned for obesity in February 2007 after the largest trial did not beat placebo [7][12]. No regulator we checked has approved it as a medicine, and it is on the WADA Prohibited List [7][12][17].

Key points

• AOD-9604 is hGH residues 177-191 plus an N-terminal tyrosine. In animals it reduced weight gain; in people it did not show a clinically meaningful weight-loss result [3][4][7][12].
• The 536-person Phase 2b “OPTIONS” trial found no significant difference from placebo, and the company ended its obesity programme [7].
• We found no ClinicalTrials.gov record for AOD-9604 and no human osteoarthritis trial. The osteoarthritis evidence is a 32-rabbit study [6][16].
• It is not an FDA-approved drug. In December 2024 an FDA advisory committee voted 0 yes, 12 no on adding it to the compounding list. We found no FDA GRAS notice for it [7][8][14][15].
• WADA’s 2026 list prohibits it (S2.2.3) [17].

What is AOD-9604?

FDA’s 2024 review describes AOD-9604 as a hexadecapeptide: a synthetic fragment of hGH (15 amino acids, residues 177-191) with an extra tyrosine at the N-terminal end [7]. A 2015 doping-analysis paper agrees [18]. Human growth hormone has 191 amino acids; the fragment is the tail end of the chain.

The company says it is “not hGH and it is not a variant of hGH” [12]. That is a 2013 company statement made during a public dispute about sport doping.

Is AOD-9604 the same as HGH fragment 176-191?

No, though the names are often swapped. The 176-191 fragment lacks the added tyrosine, and almost all human data belong to AOD-9604. Our HGH fragment 176-191 overview covers the unmodified fragment, which has no human trial that we found. WADA’s list names both separately [17].

Where did it come from?

The early fragment work came from the Department of Biochemistry at Monash University in Melbourne. The 1993 paper on hGH 177-191 and the 2000-2001 AOD-9604 papers all carry Monash affiliations and list Frank Ng as an author [1][3][4]. FDA says AOD-9604 was developed by Metabolic Pharmaceuticals Limited and first patented in the late 1990s [7]. Metabolic Pharmaceuticals Pty Ltd later appears in company releases as a wholly owned subsidiary of Calzada Ltd (ASX: CZD) [10][12]. We did not open a document describing how the work moved from Monash to the company, so that link is unverified.

What did animal studies find?

All of this is non-human, and most came from the Monash group.

• Rats, 2000. In obese Zucker rats, 19 days of oral AOD-9604 cut weight gain by more than 50% (15.8 g versus 35.6 g) and raised fat-tissue lipolytic activity without the insulin-sensitivity harm seen with intact hGH. Group size is not in the abstract [3].
• Mice, 2001. In obese ob/ob mice treated for 14 days, hGH and AOD-9604 both reduced weight gain and raised fat oxidation. AOD-9604 did not bind the hGH receptor or drive cell proliferation. Group size is not in the abstract [4].
• Knock-out mice, 2001. The long-term effect was absent in beta-3 adrenergic receptor knock-out mice, though both compounds raised that receptor’s expression. The authors concluded the actions are not mediated directly through it [5]. FDA’s review also reports that the mechanism is not established [7].
• Rabbits, 2015. In 32 rabbits with collagenase-induced knee osteoarthritis, weekly intra-articular AOD-9604 gave lower cartilage-damage scores than saline [6]. The company announced the same study in February 2013 [13].

Rodent weight results poorly predict human body fat. The 1993 and 1994 papers used 177-191 without the tyrosine [1][2].

Does AOD-9604 work for fat loss?

In the human trials, not in a way that held up. Company releases and FDA’s briefing describe six placebo-controlled studies in 925 people, run between 2001 and 2007 in Manchester and Australia [7][12]. All were funded by Metabolic Pharmaceuticals, and the authors of the safety paper were employees or consultants of the company [7]. We did not open the trial papers; the table is FDA’s summary.

Study	Population	Length	Reported result
Intravenous dose escalation	23 men with obesity	4 weekly sessions	Fatty-acid marker rose; average loss 0.58 kg over 3 weeks, not different from placebo [7]
Oral dose escalation	16-17 men with obesity	4 weekly sessions	Marker rose; no significant weight loss versus placebo [7]
Dose escalation	36 men with obesity	1 week	About 1 kg versus 0.6 kg on placebo at one dose; no further detail [7]
Phase 2 (conference abstract, 2005)	300 adults aged 30-65	12 weeks, oral daily	Authors reported small differences, 0.22 versus 0.07 kg per week at the best arm; FDA found the meaning unclear; no full paper found [7]
Phase 2b OPTIONS	536 enrolled, 502 randomized, aged 18-65, BMI 30-45	24 weeks, oral daily, plus supervised diet and exercise	No significant difference from placebo on the primary endpoint [7]

On 21 February 2007 the company announced that the Phase 2b results “do not support the commercial viability” of the drug for obesity and that development for that condition was terminated [7]. In its own wording, AOD-9604 “did not show a clinically meaningful weight loss outcome across the total trial population” [12]. FDA noted that the OPTIONS trial does not appear to have been published [7]. The 2007 quotation comes from FDA’s reproduction; we could not open the release.

What about osteoarthritis?

After 2007 the company pointed to cartilage repair. In April 2013 it said that “to date, work has only been done in preclinical studies” and that it saw osteoarthritis as the best opportunity [12]. The preclinical work was in-vitro cartilage results (2012) and the rabbit study [6][13]. We found no human osteoarthritis trial of AOD-9604.

ClinicalTrials.gov returned zero records for “AOD9604” and “AOD-9604” on 2026-11-09, and FDA’s own search in 2024 found none either [7][16]. A related compound, LAT8881 (Lateral Pharma), has small registered pain and migraine trials [16] and is described as a C-terminal hGH fragment [19]. We did not verify it is the same molecule, so we do not count those trials.

Is AOD-9604 FDA-approved or legal?

• United States, as of 2026-11-09. Searches of the openFDA Drugs@FDA dataset for AOD9604, AOD-9604 and “AOD” returned no records, whereas a control search (somatropin) returned 12 [15]. FDA’s 2024 review says AOD-9604 is not a component of an approved drug [7].
• Compounding. FDA’s bulk-substances page, current as of 22 April 2026, lists AOD-9604 among substances whose nominations were withdrawn. It says compounded AOD-9604 may pose “significant risk for immunogenicity” for some routes and that FDA “identified serious adverse events that may be associated with AOD-9604, though causality is not clear” [9]. On 4 December 2024 the Pharmacy Compounding Advisory Committee voted 0 yes, 12 no on placing it on the 503A bulks list [8].
• GRAS (food ingredient). In June 2012 the company announced a “conditional GRAS status determination” by an expert panel it had contracted, calling it “self-affirmed” [11]. That is not an FDA decision. We searched FDA’s GRAS Notice Inventory for “AOD9604” and “AOD-9604” on 2026-11-09 and found no records, with a control search returning 47; “AOD” returned one unrelated inositol notice and “Calzada” none [14]. So we found no notice, and there is no FDA response letter to quote. An April 2013 company release calls the status “unconditional,” which differs from the 2012 wording [11][12].
• Australia. The company said in April 2013 that no health authority had approved it as a pharmaceutical [12]. FDA’s briefing says Australia’s scheduling advisory committee recommended listing it as a performance and image enhancing drug [7]. The TGA page timed out when we tried to open it, so the schedule is unverified.
• EU, UK, Germany. Not checked in their registers. FDA’s 2024 search of the EMA website and four pharmacopoeias found no listing [7].

Is AOD-9604 banned in sport?

Yes. Section S2.2.3 of the WADA Prohibited List 2026 (in force 1 January 2026) names “growth hormone fragments, e.g. AOD-9604 and hGH 176-191” [17]. We read it from a federation’s copy of the PDF, not WADA’s site, and did not check for a 2027 edition. In April 2013 the company reported that WADA had placed it under S0 (non-approved substances) in 2013 [12]. A 2015 paper reported it in confiscated vials in the US and built a urine test [18].

What does “research use only” mean?

It is a seller’s label for “not for human use.” It does not mean a regulator reviewed purity or identity, and it does not make human use lawful. In December 2010 the company said unapproved material was being made in China and sold to clinics, athletes and individuals, and called its purity “highly questionable” [10]. See are peptides legal and what a certificate of analysis does and does not prove.

Is AOD-9604 safe? Risks and unknowns

Per the company-funded summary FDA reviewed, adverse events were similar to placebo and no antibodies appeared in the subset tested [7]. The details are thin:

• In the 300-person, 12-week study, five people had serious events: three skin or soft-tissue tumours (basal cell carcinoma, squamous cell carcinoma, lipoma), breast cancer and melanoma. The investigator judged none related. FDA said it had concerns and the information was insufficient to rule out a link [7].
• In the 23-man intravenous study, one person had severe chest tightness judged possibly related, and 5 reported mild or moderate euphoria versus 0 on placebo [7].
• In an oral study, one serious diarrhoea event was judged possibly related [7].
• FDA found no human exposure data for subcutaneous or topical routes, the ones sold to consumers, and no FAERS reports through January 2024. It says absence of reports does not show safety [7].
• Peptides of this size can provoke immune responses, and impurities or aggregates in unregulated material may raise that risk [7].

Not studied: long-term use, people without obesity, pregnancy, interactions, injected formulations, and the identity or purity of products sold outside pharmaceutical manufacturing.

Prices for this research peptide are on the AOD-9604 compound page.

Frequently asked questions

What is AOD-9604? A synthetic 16-amino-acid peptide: hGH residues 177-191 plus an extra N-terminal tyrosine, developed for obesity [7].

Is AOD-9604 the same as HGH fragment 176-191? No. AOD-9604 carries an added tyrosine, and the human trials used AOD-9604 only. WADA’s list names both [17].

Does AOD-9604 work for fat loss? The largest trial (536 enrolled, 24 weeks) found no significant difference from placebo, and obesity development ended in 2007 [7].

Is AOD-9604 FDA-approved or legal? It is not an approved drug, and an FDA advisory committee voted against adding it to the compounding list [8][15]. We found no FDA GRAS notice for it [14]. Other countries were not fully checked.

Is AOD-9604 banned in sport? Yes, under S2.2.3 of the WADA 2026 list [17].

Is AOD-9604 safe? Short company-funded trials reported few drug-related events, but FDA called the data limited and noted unexplained serious events [7][9].

Sources

1. Wu Z, Ng FM, Biochemistry and Molecular Biology International, “Antilipogenic action of synthetic C-terminal sequence 177-191 of human growth hormone” (1993). PMID 8358331, via Europe PMC API (abstract and Monash affiliation only).
2. Natera SH, Jiang WJ, Ng FM, “Reduction of cumulative body weight gain and adipose tissue mass in obese mice: response to chronic treatment with synthetic hGH 177-191 peptide” (1994). PMID 7987248, via Europe PMC API (abstract only).
3. Ng FM et al., Hormone Research, “Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone” (2000). PMID 11146367, via Europe PMC API (abstract only).
4. Heffernan MA et al., International Journal of Obesity, “Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment” (2001). PMID 11673763, via Europe PMC API (abstract only).
5. Heffernan M et al., Endocrinology, “The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice” (2001). PMID 11713213, via Europe PMC API (abstract only).
6. Kwon DR, Park GY, Annals of Clinical and Laboratory Science, “Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model” (2015). PMID 26275694, via Europe PMC API (abstract only).
7. FDA, Pharmacy Compounding Advisory Committee briefing document, “FDA Evaluation of AOD-9604-Related Bulk Drug Substances” (meeting 2024-12-04). https://www.fda.gov/media/183584/download (full text read; it summarises Wilding 2004, Herd 2005, Stier 2013 and the 2007 company release, none of which we opened)
8. FDA, “Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting” (2024-12-04). https://www.fda.gov/media/185642/download
9. FDA, “Certain bulk drug substances for use in compounding that may present significant safety risks” (content current as of 2026-04-22). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
10. Calzada Limited, ASX release “Independent Research Quantifies Large ‘Black Market’ in Sales of AOD9604 from China” (2010-12-01). https://announcements.asx.com.au/asxpdf/20101201/pdf/31vbcpv9mgkh85.pdf
11. Calzada Limited, ASX release “AOD9604 Receives GRAS Status” (2012-06-25). https://announcements.asx.com.au/asxpdf/20120625/pdf/4270mj9x71tv3k.pdf
12. Calzada Limited, ASX release “AOD9604 - Important Clarifications” (2013-04-26). https://announcements.asx.com.au/asxpdf/20130426/pdf/42fh15rvm7p65t.pdf
13. Calzada Limited, ASX release “AOD9604 Shows Positive Results in an Animal Model of Osteoarthritis” (2013-02-05). https://announcements.asx.com.au/asxpdf/20130205/pdf/42cv7mkdnkn092.pdf
14. FDA, GRAS Notice Inventory, searches for “AOD9604”, “AOD-9604”, “AOD”, “Calzada” (run 2026-11-09; control “steviol” returned 47 records). https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices
15. FDA openFDA, Drugs@FDA API searches for AOD9604, AOD-9604 and AOD (no matches; somatropin control returned 12), run 2026-11-09. https://api.fda.gov/drug/drugsfda.json
16. ClinicalTrials.gov API v2 searches for “AOD9604”, “AOD-9604” (0 records each) and “LAT8881” (NCT03865953, NCT04153409, NCT05298306; sponsor Lateral Pharma), run 2026-11-09. https://clinicaltrials.gov/
17. World Anti-Doping Agency, “Prohibited List 2026” (in force 2026-01-01), S2.2.3. Read from a copy hosted by the Hellenic federation: https://www.segas.gr/wp-content/uploads/2025/11/2026list_en_final_clean_september_2025.pdf (WADA’s own file not opened)
18. Cox HD et al., Drug Testing and Analysis, “Detection and in vitro metabolism of AOD9604” (2015). PMID 25208511, via Europe PMC API (abstract only).
19. Harpur CM et al., Clinical & Translational Immunology, “Naturally derived cytokine peptides limit virus replication and severe disease during influenza A virus infection” (2023). PMID 36969366, via Europe PMC API (abstract only).

Not verified: TGA scheduling page (timed out), EMA, MHRA and BfArM registers, the Monash-to-company licensing history, the full text of Wilding 2004, Herd 2005 and Stier 2013, and the 2007 company release (the SEC copy was an image PDF).

This article is information, not medical advice.