AOD-9604

AOD-9604 is a synthetic peptide, a modified fragment of human growth hormone, studied for fat loss — animal studies report it reduces body fat without raising IGF-1 the way full growth hormone does. It is not FDA-approved as a drug for any use. A smaller early human trial reported more weight loss than placebo, but the larger trial meant to confirm that found no real difference, and the obesity drug-development program was discontinued in 2007. A food-ingredient (GRAS) status is sometimes cited for it, which is a separate category from drug approval, and there are no brand-name products.

AOD-9604 has been studied as a fat-loss compound; it's a fragment of human growth hormone. Most research is in animals: rodent studies reported reduced body fat without raising IGF-1. A smaller Phase 2a obesity trial reported more weight loss than placebo, but the larger pivotal Phase 2b oral trial did not show statistically significant weight loss versus placebo, and the program was discontinued. More recent preclinical work has explored possible cartilage effects. These findings have not been confirmed for the injectable doses used by research communities.

Not FDA approved as a pharmaceutical drug for any indication. Phase 2b obesity development by Metabolic Pharmaceuticals (Australia) failed its primary endpoint and was discontinued in March 2007. A GRAS (Generally Recognized As Safe) status for food-ingredient use is commonly cited for AOD-9604, though a specific FDA gras Notice Inventory number has not been located — in any case GRAS is a separate regulatory category and does not constitute drug approval. Not on the FDA's permitted 503A bulks list: AOD-9604 sat in Category 2 of the interim 503A list and the nomination was withdrawn, with AOD-9604 removed from Category 2 effective 27 September 2024. TGA Australia listed AOD-9604 in Appendix D in 2015 for use in complementary/listed medicines (low regulatory bar — not equivalent to TGA pharmaceutical registration). WADA-banned in regulated sport (2026 Prohibited List, Section S2.2.3 — explicitly named under "growth hormone fragments"). Currently sold as a research peptide in jurisdictions where this is permitted.

AOD-9604 is not FDA-approved as a drug, and its safety in humans for injectable use has not been established in clinical trials. It is banned in regulated sport (named on the WADA Prohibited List). VialWise is a research and educational reference, not medical advice — consult a licensed professional.

⚠️ For research and educational purposes only. AOD-9604 is not approved by the FDA as a pharmaceutical drug for any indication. Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions.

⚠️ Precision matters at low doses. AOD-9604 is dosed in micrograms (mcg), not milligrams. Small dosing errors that look trivial in absolute terms can be significant in percentage terms when starting doses are small. A one-unit mis-draw at a 5-unit dose is a 20% error; the same one-unit error at a 50-unit dose is only 2%. Always verify draws against the in-app calculator and double-check the unit count on the syringe before injecting — most acutely at the smallest draws in your titration.

⚠️ AOD-9604 is not the same molecule as "hGH 176-191" (sometimes sold under the same shelf as "growth hormone fragment 176-191"). AOD-9604 is Tyr-hGH(177-191) — the C-terminal 15-amino-acid fragment of human growth hormone (residues 177-191) with an N-terminal tyrosine added by Metabolic Pharmaceuticals during the original drug-development program, making it a 16-amino-acid synthetic peptide. This structure is independently confirmed outside the originating research group by anti-doping analytical work, which describes AOD9604 as "a C-terminal fragment of human growth hormone from amino acids 177-191 with an additional tyrosine residue at the N-terminus."[⁹] The parent compound "hGH 176-191" is a 16-amino-acid C-terminal fragment of hGH spanning a slightly different residue range. The two compounds have substantially overlapping but not identical sequences and share the same lipolytic-fragment design rationale, but most published clinical and preclinical work specifically labeled "AOD-9604" refers to the Tyr-hGH(177-191) molecule developed by Metabolic Pharmaceuticals — not the unmodified hGH 176-191 fragment. The WADA 2026 Prohibited List names both compounds explicitly under Section S2.2.3, treating them as a single class of growth-hormone fragments. Researchers should be explicit with themselves about which fragment they are using and dose accordingly. This entry treats them as related but distinct compounds and flags inline where a citation refers to one vs the other.

⚠️ Note on evidence base. Unlike the FDA-approved GLP-1 peptides covered elsewhere in this library, AOD-9604 has no large randomized clinical trials supporting its efficacy for any indication. The pivotal Phase 2b obesity trial sponsored by Metabolic Pharmaceuticals ("OPTIONS," n≈536, oral formulation) failed its primary endpoint of statistically significant weight loss versus placebo, and the development program was discontinued in March 2007.[⁶] The cited literature consists primarily of preclinical animal studies, a small body of human safety/tolerability data, and recent in-vitro and animal work on cartilage/chondrogenic effects. Recent third-party reviews of performance-enhancing and musculoskeletal peptides reach the same conclusion — that rigorous human data for AOD-9604 is scarce and that these compounds span a wide evidence range, from regulatory-grade trial data down to a complete absence of human studies.[⁷][⁸] The mechanisms of action, efficacy claims, and dose-response relationships described in this entry should be read with that limitation in mind.

AOD-9604 (Anti-Obesity Drug 9604) is a synthetic 16-amino-acid peptide developed by Metabolic Pharmaceuticals (Australia) starting in the late 1990s. The molecule consists of the C-terminal 15 amino acids of human growth hormone (residues 177-191) with a tyrosine residue added at the N-terminus.[¹] The design rationale was to retain the lipolytic activity of full hGH while eliminating the receptor-binding portions responsible for hGH's hyperglycemic, IGF-1-elevating, and growth-promoting effects. In rodent models, AOD-9604 has been reported to induce body-fat reduction comparable to full hGH without elevating IGF-1, without producing insulin resistance, and without stimulating linear growth — distinguishing it pharmacologically from full hGH despite the structural overlap.[¹]

Mechanism. AOD-9604's lipolytic activity is mediated through upregulation of β3-adrenergic receptor (β3-AR) expression in adipocytes, with downstream effects on cAMP and lipase activation. Importantly, the lipolytic effect is not mediated by direct β3-AR binding — both AOD-9604 and full hGH increase β3-AR expression, which subsequently contributes to enhanced lipolytic sensitivity, but the upstream mechanism by which they upregulate β3-AR remains incompletely characterized.[¹] AOD-9604 does not bind the GH receptor with measurable affinity, which is why it does not produce the hyperglycemic, IGF-1-elevating, and proliferative effects of full hGH.

Clinical development history. Metabolic Pharmaceuticals advanced AOD-9604 through Phase 1, Phase 2a, and Phase 2b clinical trials in obesity in the 2000s. These were two distinct trials and their results are frequently conflated in secondary sources — the encouraging weight-loss number belongs to the earlier, smaller Phase 2a study, not to the pivotal trial that failed.

- Phase 2a (the earlier study, ~300 obese adults, ~12 weeks, oral formulation): treated groups were reported to lose more weight than placebo (~2.6 kg vs ~0.8 kg). This was an encouraging but small effect in a study not powered or designed as a registrational trial. - Phase 2b ("OPTIONS," the pivotal trial, n≈536, 2006–2007, oral formulation): the trial failed its primary endpoint — no statistically significant weight loss versus placebo was reported at any dose. The Phase 2a weight-loss figures above do not carry over to this trial and should not be quoted as its result. The trial did report a favorable safety profile, with adverse-event rates comparable to placebo across dose groups.

Metabolic Pharmaceuticals discontinued pharmaceutical development of AOD-9604 in March 2007 following the Phase 2b result.[⁶] AOD-9604 has not subsequently been advanced through any registrational clinical program; a 2026-07-18 ClinicalTrials.gov search returned zero registered trials for AOD-9604 (the original Metabolic Pharmaceuticals trials predate mandatory registration, so their absence there is expected).

Regulatory status. AOD-9604 has never received FDA approval as a pharmaceutical drug for any indication. A GRAS (Generally Recognized As Safe) status for food-ingredient use is commonly cited for AOD-9604 — but note that a specific FDA gras Notice Inventory number for the compound has not been located, and GRAS self-affirmation is in any case a regulatory category distinct from pharmaceutical drug approval that does not constitute FDA approval for therapeutic use. Some research-community marketing materials conflate GRAS food-ingredient status with pharmaceutical approval; this conflation is incorrect. On US compounding, AOD-9604 is not on the FDA's permitted 503A bulks list — it was placed in Category 2 of the interim 503A list (substances raising significant safety risks or difficult to evaluate), and that nomination was withdrawn, with AOD-9604 removed from Category 2 effective 27 September 2024, so 503A/503B compounding of AOD-9604 is not FDA-sanctioned.[¹¹] In Australia, the TGA listed AOD-9604 in Appendix D in 2015 for use in compounded/listed complementary medicines — this is a relatively low regulatory bar (TGA listed products are not routinely evaluated before marketing) and is not equivalent to TGA pharmaceutical registration. The 2026 WADA Prohibited List explicitly names AOD-9604 under Section S2.2.3 (Growth hormone, its analogues and fragments), prohibited at all times in regulated sport.[⁵] *(WADA publishes annually — re-check this entry against the 2027 Prohibited List when it publishes around October 2026.)*

Common research interests. Despite the discontinued pharmaceutical program, AOD-9604 is one of the most widely used research peptides in body-composition contexts. Common areas of research-community use include: - Fat loss / body composition during cutting cycles (the original development rationale) - Joint and cartilage support (driven by recent preclinical cartilage-regeneration data — see below) - Adjunct to GH-secretagogue stacks (CJC-1295 / Ipamorelin) on the rationale that AOD-9604 provides direct lipolytic effects while the GH peptides drive systemic GH/IGF-1 elevation - Adjunct to GLP-1 / GIP / glucagon agonist protocols during weight-loss cycles, on the rationale of preserving lean mass and accelerating fat loss

These uses are based on extrapolation from preclinical data plus accumulated researcher experience. None are FDA-approved indications.

Recent preclinical interest in cartilage / chondrogenic effects. Beginning in the mid-2010s, animal studies have explored intra-articular AOD-9604 for osteoarthritis, with reports that intra-articular injection of AOD-9604 (alone or combined with hyaluronic acid) enhances cartilage regeneration in rabbit OA models, and that AOD-9604 promotes proteoglycan and collagen production in isolated bovine chondrocytes in vitro.[³] AOD-9604 does not stimulate IGF-1 production, distinguishing the cartilage mechanism from GH-axis interventions. A 2024 third-party review specifically addressing peptides for chondrogenic induction and cartilage regeneration in osteoarthritis discusses AOD-9604 in the broader landscape of research peptides being explored for joint and cartilage applications,[⁴] and a 2026 orthopedic review likewise covers AOD-9604 among therapeutic peptides now appearing in orthopedic practice.[¹⁰] Caveat on that 2026 review: it groups AOD-9604 with growth-hormone secretagogues described as acting via IGF-1 signaling, which conflicts with the primary mechanism literature showing AOD-9604 does not elevate IGF-1;[¹] it is cited here as evidence of AOD-9604's growing presence in orthopedic reviews, not as a source for the IGF-1 mechanism. No peer-reviewed Phase 3 (or even pivotal Phase 2) human trials for cartilage / OA indications have been published as of this entry's last-updated date.

Commonly reported

• Injection site reactions (local redness, soreness)
• Mild transient flushing or warmth in the minutes after injection (uncommon)
• Headache (uncommon, typically transient)
• Fatigue or lethargy in the first 1–2 weeks of a cycle (uncommon)
• Long-term safety in humans for the injectable formulation is essentially unknown. No multi-year human safety dataset exists for the subcutaneous research-community use pattern. The Phase 2b trial's safety data is from oral administration over a matter of months and is not directly transferable. Recent independent reviews of peptides used for musculoskeletal and performance purposes reach the same conclusion — that rigorous human safety data for compounds in this group is scarce.[⁸]
• Unlike full hGH, AOD-9604 is not reported to elevate IGF-1, produce hyperglycemia, or stimulate linear growth.[¹] The theoretical IGF-1-mediated cancer concern that applies to GH and GH-secretagogue interventions is therefore less directly applicable to AOD-9604, though the absence of long-term safety data means this should not be treated as a definitive absence-of-risk claim.

Pregnancy and lactation: no data; default to contraindicated — no published reproductive toxicology in humans

Pediatric use: no data — should not be used in researchers under 18; AOD-9604's parent molecule (hGH) is heavily regulated in pediatric populations and the fragment has not been studied in children

Active anti-coagulation, immunosuppressive, or chemotherapeutic regimens — no published interaction data

WADA-banned in regulated sport. AOD-9604 is explicitly named under Section S2.2.3 ("growth hormone fragments, e.g. AOD-9604 and hGH 176-191") in the WADA 2026 Prohibited List.[⁵] Researchers competing in any WADA-tested sport, or in regulated equine racing, will test positive. This is a regulatory compliance issue, not a safety issue, but is the most common reason a researcher would need to disclose use.

Regulatory note (US): A GRAS food-ingredient status is commonly cited for AOD-9604, but it is not FDA-approved as a pharmaceutical drug, and the two are different regulatory categories. On compounding specifically: AOD-9604 was nominated for the FDA's 503A bulk drug substances list and placed in Category 2 (substances raising significant safety risks or that are difficult to evaluate); that nomination was withdrawn and AOD-9604 was removed from Category 2 effective 27 September 2024. AOD-9604 is therefore not on the permitted 503A bulks list, and compounding it under section 503A/503B is not FDA-sanctioned.[¹¹] Researchers should be aware of the regulatory environment in their jurisdiction.

Regulatory note (Australia): Listed in TGA Appendix D in 2015 for use in compounded/listed complementary medicines. This is a low regulatory bar and is not equivalent to TGA pharmaceutical registration.

Peptide

A short chain of amino acids, the building blocks of proteins. Many compounds in this library are peptides.

Growth hormone fragment

A peptide made from a portion of the growth hormone molecule rather than the whole hormone.

Preclinical

Research done in cells or animals, before human clinical trials. Promising preclinical results don't always hold up in people.

Subcutaneous

An injection into the fatty layer just under the skin, rather than into a muscle or vein.

WADA Prohibited List

The list of substances banned in regulated sport by the World Anti-Doping Agency.

1. Heffernan M, Summers RJ, Thorburn A, Ogru E, Gianello R, Jiang WJ, Ng FM. (2001). 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. Endocrinology, 142(12):5182–5189.(PMID 11713213)
2. Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. (2000). Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Hormone Research, 53(6):274–278.(PMID 11146367)
3. Kwon DR, Park GY. (2015). Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model. Annals of Clinical and Laboratory Science, 45(4):426–432.(PMID 26275694)
4. Liao HJ, Chen HT, Chang CH. (2024). Peptides for Targeting Chondrogenic Induction and Cartilage Regeneration in Osteoarthritis. Cartilage (online ahead of print, 2024 Sep 18).(PMID 39291443)
5. World Anti-Doping Agency. The 2026 Prohibited List, International Standard (effective 1 January 2026). Canonical PDF: wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf (linked from the WADA landing page at wada-ama.org/en/prohibited-list; local archival copy in `docs/legal/wada-2026-prohibited-list.pdf`). AOD-9604 is named explicitly under Section S2.2.3 (Growth hormone, its analogues and fragments). Verbatim wording from the canonical PDF, page 8: "Growth hormone fragments, e.g. AOD-9604 and hGH 176-191" — listed as one bullet under S2.2.3, alongside the bullet for "growth hormone analogues, e.g. lonapegsomatropin, somapacitan and somatrogon." Prohibited at all times.
6. Metabolic Pharmaceuticals (Australia). AOD-9604 development program — Phase 2b obesity trial reporting and program-discontinuation history. Contemporaneous coverage available at news-medical.net/news/2004/12/16/6878.aspx (initial Phase 2b enrollment update, December 2004) and BioSpace's "Metabolic Pharmaceuticals's Obesity Trial Update: First 100 Subjects Complete The Phase 2B Trial Of AOD9604" (2005 timeframe).. Background reading on the Phase 2a and Phase 2b trial designs and on Metabolic Pharmaceuticals' subsequent decision to discontinue pharmaceutical development. ⚠️ Phase-conflation warning locked here 2026-07-18: secondary sources routinely attach the encouraging Phase 2a figures (~2.6 kg treated vs ~0.8 kg placebo, ~300 participants, ~12 weeks) to the pivotal Phase 2b "OPTIONS" trial (n≈536, 2006–2007), which actually reported no statistically significant weight loss versus placebo. This entry keeps the two separate; any future edit to these numbers must preserve that separation. The March 2007 discontinuation date follows the same pattern as CJC-1295's program-halt history — non-PubMed contemporaneous sources are required for accurate reporting and the second-pass discipline applies.
7. Dominikowski A, et al. (2026). The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Frontiers in Endocrinology (Lausanne), 17:1822475.(PMID 42395176)
8. Mendias CL, Awan TM. (2026). Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Medicine.(PMID 41966639)
9. Cox HD, et al. (2014). Detection and in vitro metabolism of AOD9604. Drug Testing and Analysis, 7(1):31–38.(PMID 25208511)
10. Rahman OF, Lee SJ, Seeds WA. (2026). Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions. JAAOS Global Research and Reviews, 10(1).(PMID 41490200)
11. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — interim policy category lists and associated briefing materials. fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act. The regulatory source that resolves this entry's former flag. Per FDA, AOD-9604 was placed in Category 2 of the interim 503A bulks list (bulk drug substances that raise significant safety risks or are otherwise difficult to evaluate); the nomination was subsequently withdrawn and AOD-9604 removed from Category 2 effective 27 September 2024, with peptide substances routed to Pharmacy Compounding Advisory Committee review. Net effect: AOD-9604 is not on the permitted 503A bulks list, so compounding it under section 503A/503B is not FDA-sanctioned.

• CJC-1295 / Ipamorelin Blend — discussed together in this entry's stacks section
• Tesamorelin — discussed together in this entry's stacks section
• BPC-157 / TB-500 Blend — discussed together in this entry's stacks section
• HGH (Human Growth Hormone) / Somatropin — same mechanism class
• IGF-1 LR3 — same mechanism class
• MGF — same mechanism class