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AOD9604

Quick Summary Points

  • AOD9604 is a peptide developed by Australian company, Metabolic Pharmaceuticals, mimicking the lipolytic region of human growth hormone
  • It's been marketed as a weight loss supplement, aid for muscle & cartilage repair, & potential osteoarthritis treatment
  • Legally, AOD9604 is a prescription-only medicine in Australia & is deemed illegal for athlete usage by WADA
  • Despite being unapproved by the TGA, it's available through a doctor's prescription & from a compounding pharmacy
  • The peptide's developers claim it's safe & free of side effects
  • AOD9604 showed initial promise in weight loss when tested on obese mice
  • Six human clinical trials, however, revealed no weight loss or changes in body composition
  • Despite its failure, Metabolic tried to compete against knock-off versions by licensing manufacturing rights to other companies
  • AOD9604 was also incorporated into an anti-cellulite cream but later dropped due to high costs & ineffectiveness
  • The compound is approved for use as a food additive in the US at levels up to 1mg per day, but trial doses were typically much higher
  • There is no scientific backing for the peptide's effectiveness, especially given its lack of efficacy when taken orally
  • Although popular due to press coverage & word of mouth, the safety & impact of injecting AOD9604 remains unstudied
  • Legal alternatives to AOD9604 include natural-type fat burners & testosterone boosters

Introduction

AOD9604, a peptide developed & patented by Metabolic Pharmaceuticals in the late 1990s, has gained considerable attention over the years. Marketed as a weight loss supplement, potential aid for muscle & cartilage repair, & a potential osteoarthritis treatment, AOD9604 has had a controversial history. Despite claims of safety & efficacy, rigorous scientific testing has revealed a different story. This article provides a comprehensive review of the development, trials, legal status, & current standing of AOD9604 in the health & fitness market.

AOD9604: What is it?

AOD9604 is a type of peptide, essentially a chain of amino acids, developed and patented by Metabolic Pharmaceuticals, an Australian company, in the late 1990s. The term "AOD" is an abbreviation for "Anti Obesity Drug". The peptide has an amino acid sequence that mimics the lipolytic (fat-burning) region of human growth hormone. Over the years, it has been marketed as a weight loss supplement, a potential aid to muscle and cartilage repair, and even as a treatment for osteoarthritis. Other names for AOD9604 include lipotropin and Tyr-hGH fragment. Today, this peptide is typically available as a transdermal cream or an injectable.

AOD9604: Legal Status

In Australia, AOD9604 is classified as a Schedule 4 drug under the Poisons Standard, as per the Therapeutic Goods Administration (TGA) regulations. This categorization implies that the drug is a prescription-only medicine and can only be obtained legally if prescribed by a licensed medical practitioner. It is important to underline that possession of a Schedule 4 drug without a valid prescription is illegal in Australia. Thus, while AOD9604 can be lawfully accessed with a prescription, any possession without one is considered a contravention of the law.

It has not been approved by any pharmaceutical authority worldwide, except for the previously mentioned "Generally Regarded As Safe" designation by the FDA (this approval now is quite dated).

AOD9604 is currently classed by the World Anti-Doping Agency (WADA) as a non-approved substance, which means it is illegal for use by athletes in competition. WADA policy is to ban all substances that are suspected of being performance-enhancing, even in the absence of clinical proof (1,2).

AOD9604: Why do people use it?

AOD9604 is widely promoted by numerous manufacturers as a product capable of burning fat & aiding in the repair of muscle and cartilage. The fact that this peptide is derived from & reportedly imitates the effects of a potent, anabolic substance that's banned adds a psychological appeal to many potential users. The attention brought about by the Australian Football League's "peptides" scandal in early 2013 & the subsequent report by the Australian Crime Commission(1) only heightened this interest.

While AOD9604 is not approved by the Australian Therapeutic Goods Administration (TGA), & thus is technically illegal to the public, it can be legally acquired through a doctor's prescription & dispensed by a compounding pharmacy(2). This is the case for many experimental substances and it significantly aids the reputation of AOD9604. It gives an impression that, like other medically prescribed drugs, AOD9604 is effective & of high quality. All these reasons, collectively, perpetuate the perception that peptides, such as AOD9604, are highly effective. After all, they wouldn't be banned without reason, would they?

Metabolic Pharmaceuticals, the company that developed AOD9604, has reported in vitro trials indicated the peptide might stimulate the growth of bone, muscle, & cartilage cells. However, these results are yet to be replicated in animals or humans(4). Despite speculation that Metabolic was supplying AOD9604 to players at the Essendon Football Club as part of a clandestine clinical trial, & Essendon players were found to have taken AOD9604, the company has emphatically denied this accusation, maintaining that it has not conducted any human trials since 2007(2). According to Metabolic Pharmaceuticals, AOD9604 has been scientifically demonstrated to be safe and free of side effects(2), & is reportedly very difficult to detect in the blood.

AOD9604: The Negatives

Despite its initial promise, the most significant downside of AOD9604 is that it has been subjected to rigorous scientific testing & found to be ineffective in humans(3). When AOD9604 was initially developed, it showed considerable potential as a weight loss aid. Obese mice given the peptide showed weight reduction, increased fat oxidation, and elevated plasma glycerol, indicating fat burning(5). However, subsequent studies in obese mice and rats aimed at showing that the peptide burns fat like human growth hormone concluded otherwise. It turned out that the resemblance of this peptide to hGH was inconsequential, & scientists were unable to ascertain how this peptide worked in mice(6).

Metabolic subsequently shifted focus to human studies, conducting six clinical trials with 925 participants between 2001 & 2007. None of these trials demonstrated that AOD9604 led to weight loss or changes in body composition(3). In 2007, Calzada, Metabolic's parent company, reported to its shareholders that AOD9604 showed no promise and was being discontinued as a weight loss drug(2,3). The failure was attributed to inefficient absorption of the peptide drug via oral administration, as used in the trials, even though rodent studies demonstrated this delivery method to be effective. At this point, Metabolic had invested a staggering $50 million in the development & trials of AOD9604.

In 2010, hearing that bodybuilders were importing knock-off versions of the patent-protected peptide from China, Metabolic began licensing manufacturing rights to other companies in an attempt to compete(7, 8). Desperate to recover this investment, they invested a little more in developing technology that allowed the peptide to be absorbed through the skin, collaborating with a company called Phosphagenics(4). The peptide was then licensed for use in BodyShaper, an anti-cellulite cream. However, Phosphagenics eventually dropped AOD9604 from BodyShaper, citing high cost & ineffectiveness(3).

When the AFL Peptides scandal broke, Calzada was compelled to clarify the facts about AOD9604, issuing a carefully worded press release aimed at potential investors. The press release emphasized that AOD9604 had been deemed safe in large-scale clinical trials but conveniently ignored its lack of effectiveness(2,4). It also highlighted AOD9604's success in stimulating bone growth & repairing cartilage and muscle cells in in-vitro trials. The black market uses of this peptide for muscle repair & obesity treatment were also mentioned in the release, & it was clear from media coverage that Calzada capitalized on this exposure(8).

If there is one consensus in the scientific community about AOD9604, it's that it is safe and devoid of side effects. Calzada, after testing the peptide as an anti-obesity & anti-arthritic agent, managed to get the peptide declared "Generally regarded as safe" by the FDA, allowing its legal use as a food additive in the United States. Calzada is now attempting to penetrate the US over-the-counter supplement & "Nutraceutical" market with AOD9604(2,4). Interestingly, the compound has only been approved for use at levels of up to 1mg per day(2), whereas trial doses were typically around 500ug/kg(5,6), implying a 100kg person received 50mg of the peptide daily.

There is no science behind the peptide or the dosage, especially since Calzada themselves previously stated that AOD9604 is not effective orally(2). While press coverage and word of mouth have created a buzz around AOD9604, there is no research on the safety & effect of injecting

AOD9604: Alternatives

If you're seeking AOD9604 alternatives, consider fat burners or testosterone boosters. Fat burners from aid in weight loss by enhancing fat metabolism. Testosterone boosters can increase muscle growth & energy, potentially aiding fat loss. We offer a range of best-selling testosterone boosters to cater to various fitness goals. Always consult a healthcare professional before starting new supplements.

In Conclusion

Despite its initial promise & the buzz it has generated over the years, AOD9604's journey from a hopeful weight-loss aid to an ineffective supplement is a testament to the rigorous scientific processes required for a drug's approval. Despite the peptide being deemed safe, its lack of proven efficacy in weight loss & body composition alteration has cast a shadow over its potential. The lack of science behind the peptide & its dosage calls into question its effectiveness. It's critical to consult a healthcare professional before starting any new peptide-type use or treatment.

References

(1) Performance and Image-enhancing substances. Australian Crime Commission. http://www.crimecommission.gov.au/publications/other-publications/organised-crime-drugs-sport/performance-image-enhancing-substances Accessed 3rd December 2013
(2) "AOD9604 – Important Clarifications" Calzada, 26th April 2013. http://www.asx.com.au/asxpdf/20130426/pdf/42fh15rvm7p65t.pdf Accessed 4th December 2013
(3) Much ado about nothing: The peptide they say never worked. Natasha Wallace. http://www.smh.com.au/sport/much-ado-about-nothing-the-peptide-they-say-never-worked-20130802-2r4ug.html Accessed 3rd December 2013
(4) Calzada Limited – Metabolic. http://calzada.com.au/metabolic-pharmaceuticals-pty-ltd/ Accessed 4th December 2013
(5) Heffernan MA, Thorburn AW, Fam B, Summers R, Conway-Campbell B, Waters MJ and NG FM. 2001a. International Journal of Obesity. 25: 1442-1449. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment.
(6) Heffernan M, Summers R, Thorburn A, Ogru E, Gianello R, Jiang W-J and Ng FM. 2001b. Endocrinology. 142(12): 5182-5189. The effects of human GH and its lipolytic fragment (A)D9604) on lipid metabolism following chronic treatment in obese mice and β3-AR knock-out mice.
(7) Boreham T. Bulk up on this fat fighting firm (Calzada). March 2 2010. http://www.theaustralian.com.au/business/opinion/bulk-up-on-this-fat-fighting-firm-calzada-czd-35c/story-e6frg9lo-1225835816678 Accessed 4th December 2013
(8) Fat fighting firm worth a guernsey. April 12 2013. http://www.theaustralian.com.au/business/opinion/fat-fighting-firm-worth-a-guernsey/story-e6frg9lo-1226618621089# Accessed 4th December 2013

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