Is AOD-9604 approved or legal?

AOD-9604 is not approved as a drug anywhere in the world. Its pivotal obesity trial failed in 2007 and no Phase 3 trial was conducted. It has FDA GRAS status as a food ingredient at up to 1 mg/day oral — this is a safety designation, not a drug approval. It cannot be legally compounded in the US and is a prescription-only substance in Australia. It is prohibited in competitive sport by WADA under S2 (growth hormone fragments) at all times. Products are sold for research use only.

Did the clinical trials show weight loss?

Small early Phase 2a trials showed a modest signal (~1.8–2.6 kg more weight loss than placebo). However, the pivotal Phase 2b OPTIONS trial — 536 subjects, 24 weeks, three oral doses — found no statistically significant weight loss vs placebo at 12 or 24 weeks. The obesity drug programme was discontinued after this result.

What is AOD-9604's half-life?

Approximately 3 minutes by IV in pig pharmacokinetic studies — very short, reflecting rapid peptidase degradation. No peer-reviewed human pharmacokinetic data for subcutaneous dosing has been published. A serum metabolite (CRSVEGSCG) is more persistent and is used for anti-doping detection. Community figures of ~30 minutes for SC half-life are not sourced from peer-reviewed human PK studies.

How does AOD-9604 differ from regular growth hormone?

AOD-9604 does not bind the growth hormone receptor, does not raise IGF-1, and has no effect on blood glucose or insulin — confirmed across all clinical trials. This means it does not produce the growth-promoting or anti-insulin effects of full-length hGH. The trade-off is that it also failed to produce meaningful weight loss in humans at the doses tested.

What is the GRAS designation and does it mean AOD-9604 is safe?

GRAS (Generally Recognized as Safe) status was granted circa 2014 for oral use as a food ingredient at up to 1 mg/person/day. It reflects the acceptable short-term safety profile demonstrated in ~893 clinical trial subjects. It does NOT indicate efficacy and says nothing about the safety of subcutaneous injection, higher doses, or chronic long-term use. Research-grade material is unregulated.

Is AOD-9604 good for fat loss based on the evidence?

Not conclusively. Preclinical data in animals support lipolytic mechanisms, but the compound failed its pivotal human obesity trial. Community use of subcutaneous injections at 300 mcg/day is anecdotal and uses a route not systematically tested in the human trials. Claims of fat-loss efficacy in humans should be regarded as unproven.

Metabolic

AOD-9604

Also known as: Anti-Obesity Drug 9604, AOD9604, hGH fragment 177-191, Tyr-hGH(177-191)

A synthetic C-terminal fragment of human growth hormone studied for fat metabolism; failed its pivotal obesity trial but has human safety data and FDA food-ingredient GRAS...

Last updated July 18, 2026

Reconstitute this peptide Buy AOD-9604

Overview

AOD-9604 is a synthetic 16-amino-acid peptide corresponding to residues 177–191 of the C-terminal region of human growth hormone (hGH), with a tyrosine residue added at the N-terminus (sequence: Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe). The two cysteine residues form an intramolecular disulfide bridge. It was developed in the 1990s by researchers at Monash University, Australia, on the hypothesis that the lipolytic activity of hGH could be isolated to its C-terminal region, separated from the growth-promoting and glucose-metabolising effects of the intact hormone. AOD-9604 underwent six randomised, double-blind, placebo-controlled clinical trials between the late 1990s and 2007, conducted primarily in Australia by Metabolic Pharmaceuticals Pty Ltd (a Monash University spin-out). These trials enrolled a total of approximately 893 subjects. While small Phase 2a oral studies showed a modest signal (~1.8–2.6 kg more weight loss vs placebo), the pivotal Phase 2b OPTIONS study — a 536-subject, 24-week randomised trial across 16 Australian sites — failed to meet its primary endpoint of weight loss at 12 weeks at any oral dose tested (0.25 mg, 0.5 mg, or 1.0 mg daily). The obesity drug programme was discontinued in 2007 and no Phase 3 trial was conducted. Following the clinical programme, Metabolic Pharmaceuticals pursued FDA GRAS (Generally Recognized as Safe) designation for AOD-9604 as a food ingredient, which was granted circa 2014 at up to 1 mg per person per day by oral route. This GRAS status pertains to oral food use and says nothing about efficacy or the safety of other routes. AOD-9604 is not approved as a drug anywhere in the world. It is explicitly named on the WADA Prohibited List under Section S2 (growth hormone fragments) and is prohibited at all times in competitive sport. Products are sold as research-use-only material.

How it works

AOD-9604 was designed to retain the lipolytic (fat-mobilising) domain of hGH while shedding the portions responsible for growth and metabolic side effects. The compound has been confirmed to NOT bind the growth hormone receptor — it cannot displace hGH from its receptor in binding assays and does not dimerize the receptor — and does NOT elevate circulating IGF-1. It also does not affect blood glucose or insulin sensitivity, which distinguished it from full-length hGH. AOD-9604 stimulates lipolysis and inhibits lipogenesis in adipose tissue. In preclinical studies, it inhibits acetyl-CoA carboxylase, the rate-limiting enzyme in de novo fatty acid synthesis, and activates hormone-sensitive lipase, promoting triglyceride breakdown. In obese mice, it upregulates beta-3 adrenergic receptor (beta-3 AR) mRNA expression in adipose tissue; however, Heffernan et al. (2001) demonstrated using beta-3 AR knockout mice that acute lipolytic effects persist in the absence of beta-3 AR, indicating that beta-3 AR upregulation is a downstream consequence rather than the primary signalling mechanism. The upstream receptor or intracellular signalling cascade directly activated by AOD-9604 has not been fully characterised in published literature. These mechanisms are established in vitro and in animal models. The failure of the pivotal human trial to demonstrate statistically significant weight loss at the oral doses tested means that extrapolation of preclinical fat-loss findings to human outcomes cannot be made.

Researched effects

Preclinical Stimulates lipolysis and inhibits lipogenesis in adipocytes without activating the growth hormone receptor or raising IGF-1
Preclinical Reduces fat mass in diet-induced obese mouse models
Preclinical Upregulates beta-3 adrenergic receptor expression in adipose tissue of obese mice
Clinical Modest weight loss signal in small Phase 2a oral trials (~1.8–2.6 kg vs placebo)
Clinical Does not affect blood glucose, insulin, IGF-1, or bone density markers in human studies
Preclinical May support cartilage regeneration in intra-articular injection models (rabbit OA)
Anecdotal Reduces body fat and improves body composition (community-reported with SC dosing)

Evidence levels: Clinical (human trials) · Preclinical (animal/lab) · Anecdotal (community-reported).

Dosing reference

For research reference only — not a recommendation.

Clinical / studied dosing

No approved clinical dosing exists. In Phase 1 single-dose studies, IV/SC doses of 25–400 mcg/kg were evaluated. Phase 2a oral studies tested 1, 5, 10, 20, and 30 mg/day. The pivotal Phase 2b OPTIONS trial used 0.25 mg, 0.5 mg, and 1.0 mg orally daily — none of which demonstrated statistically significant weight loss vs placebo. The GRAS designation covers oral use as a food ingredient at up to 1 mg/person/day. No dose has been established as therapeutically effective.

Community-reported dosing (anecdotal)

Anecdotal and research-reference only; not medical advice. Community protocols (r/Peptides, vendor guides) most commonly describe subcutaneous injections of approximately 300 mcg (0.3 mg) per day, typically administered in a fasted state in the morning, in cycles of 8–12 weeks. Note: this route was not the primary route tested in human trials (which used oral dosing), so no published human pharmacokinetic data directly supports community SC dose selection. Oral use at the GRAS-permitted level (≤1 mg/day) has also been discussed, but the failed oral trial at these doses reduces enthusiasm for this route. These protocols are entirely anecdotal and represent unverified self-experimentation, not evidence-based dosing.

Half-life: Intravenous half-life is approximately 3 minutes in pig models — consistent with rapid peptidase degradation. No peer-reviewed human pharmacokinetic study with specific half-life values for subcutaneous dosing has been published. A stable serum metabolite (the fragment CRSVEGSCG) is more persistent than the parent compound and is the target for anti-doping detection (Cox et al., 2015). A widely cited community figure of ~30 minutes for SC half-life appears unsourced from any peer-reviewed human PK study.
Routes: subcutaneous, oral

Safety & side effects

AOD-9604 has one of the more characterised short-term human safety profiles among research peptides, by virtue of having been through six controlled clinical trials in ~893 subjects. Across all trials, no serious adverse events were attributed to the drug, no dose-dependent adverse effects were identified, and the rate of common mild adverse events (headache, GI symptoms) was statistically indistinguishable from placebo. No subjects developed anti-AOD-9604 antibodies. No effects on IGF-1, insulin, blood glucose, or bone density markers were observed. However, long-term safety beyond the trial durations (up to 24 weeks) has not been evaluated. Subcutaneous injection risks (infection, injection-site reactions) apply to any injectable research compound, and product quality of unregulated material is an inherent risk. AOD-9604 is NOT approved as a drug. The FDA has reviewed it and it does not appear on the list of bulk drug substances eligible for compounding (Category 1); compounding pharmacies have received warning letters for dispensing it. In Australia it is a TGA prescription-only substance. AOD-9604 is explicitly named on the WADA Prohibited List under S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics — specifically as a growth hormone fragment) and is prohibited at all times in competitive sport, with no therapeutic use exemption pathway available. Products are for research use only and not for human consumption.

Research summary

The AOD-9604 research story has an unusually clear arc for a research peptide: genuine preclinical promise, a serious clinical development programme, a definitive negative pivotal trial result, and residual GRAS status for oral food use. The preclinical evidence — lipolysis promotion without IGF-1 elevation, fat mass reduction in obese animals, and identification of a partial beta-3 AR mechanism — was real and reasonably compelling. Phase 2a oral human data produced a modest signal. But the 536-subject, 24-week OPTIONS trial, the most rigorous test of the oral obesity hypothesis, found no statistically significant weight loss at any dose. Post-programme, a single published rabbit model (Yoo et al., 2015) suggests potential for cartilage regeneration via intra-articular injection, but no human trials in this indication have been reported. The anti-doping literature (Cox et al., 2015) confirms that a metabolite is detectable in serum and that anti-doping agencies actively monitor for it — consistent with its WADA S2 prohibition. For practitioners of evidence-based medicine, the honest summary is that AOD-9604 does not have proven efficacy in humans for any indication. Its preclinical fat-loss mechanisms are real but did not translate to the tested oral doses in a controlled human trial. The GRAS designation confirms acceptable short-term oral safety, not efficacy. The subcutaneous dosing popular in research peptide communities bypasses the tested route entirely and has no published human trial support.

FAQ

Is AOD-9604 approved or legal?: AOD-9604 is not approved as a drug anywhere in the world. Its pivotal obesity trial failed in 2007 and no Phase 3 trial was conducted. It has FDA GRAS status as a food ingredient at up to 1 mg/day oral — this is a safety designation, not a drug approval. It cannot be legally compounded in the US and is a prescription-only substance in Australia. It is prohibited in competitive sport by WADA under S2 (growth hormone fragments) at all times. Products are sold for research use only.
Did the clinical trials show weight loss?: Small early Phase 2a trials showed a modest signal (~1.8–2.6 kg more weight loss than placebo). However, the pivotal Phase 2b OPTIONS trial — 536 subjects, 24 weeks, three oral doses — found no statistically significant weight loss vs placebo at 12 or 24 weeks. The obesity drug programme was discontinued after this result.
What is AOD-9604's half-life?: Approximately 3 minutes by IV in pig pharmacokinetic studies — very short, reflecting rapid peptidase degradation. No peer-reviewed human pharmacokinetic data for subcutaneous dosing has been published. A serum metabolite (CRSVEGSCG) is more persistent and is used for anti-doping detection. Community figures of ~30 minutes for SC half-life are not sourced from peer-reviewed human PK studies.
How does AOD-9604 differ from regular growth hormone?: AOD-9604 does not bind the growth hormone receptor, does not raise IGF-1, and has no effect on blood glucose or insulin — confirmed across all clinical trials. This means it does not produce the growth-promoting or anti-insulin effects of full-length hGH. The trade-off is that it also failed to produce meaningful weight loss in humans at the doses tested.
What is the GRAS designation and does it mean AOD-9604 is safe?: GRAS (Generally Recognized as Safe) status was granted circa 2014 for oral use as a food ingredient at up to 1 mg/person/day. It reflects the acceptable short-term safety profile demonstrated in ~893 clinical trial subjects. It does NOT indicate efficacy and says nothing about the safety of subcutaneous injection, higher doses, or chronic long-term use. Research-grade material is unregulated.
Is AOD-9604 good for fat loss based on the evidence?: Not conclusively. Preclinical data in animals support lipolytic mechanisms, but the compound failed its pivotal human obesity trial. Community use of subcutaneous injections at 300 mcg/day is anecdotal and uses a route not systematically tested in the human trials. Claims of fat-loss efficacy in humans should be regarded as unproven.

References

All content is for research and educational use only and is not medical advice. Products are sold for laboratory research only and are not for human consumption.