AOD9604

It’s now obvious that peptides and peptide fragments caused a real bodybuilding and sport doping revolution. Because pharmaceutical companies where unable to bring their products to the market, clever China based companies marketed the peptides. Many people where bashing these peptides and repeated the words of "scientists" that just like the days of early steroid usage.

On the message and discussion boards people reported mixed results. I recently found out that one of the biggest suppliers of Blue Top growth hormone, sold his vials dosed as 2-4-6-8 and 10 iu´s . Most people buy their peptides domestic, via online shops or "pharmacies" or via Chinese middle-men. And the fact that you pay for a 10 iu vial doesn´t mean that you get a 10 iu vial. And the fact that all the different peptides bear different colored tops and most of them just blue tops, doesn´t tell you anything about its content. Analyses often showed us surprising results. Just like it gave us laughs when someone mailed me that his " IGF-LR3" gave him erections and that he felt that he was tanning. “Do you think it’s real? “ Its therefore not surprising that not everyone is enthusiastic.

AOD9604 is a peptide (a chain of amino acids) which was developed and patented by a company called Metabolic Pharmaceuticals in Australia in the late 1990s. AOD stands for "Anti-Obesity Drug". This peptide is has an amino acid sequence that mimics the lipolytic region of human growth hormone (the region of this hormone thought to be responsible for burning fat) and it has been promoted variously as a weight loss supplement, as an aid to muscle and cartilage repair, and a treatment for osteoarthritis by its manufacturers. It is also known as lipotropin and Tyr-hGH fragment as an injectable, and it is also available in Australia these days as a transdermal cream. Personally I’m convinced that you should inject it. I also don’t believe that it works orally as a tablet.

AOD9604 is promoted heavily by various manufacturers as a substance that is able to burn fat and assist in the repair of muscle and cartilage. The fact that this product derives from, and claims to mimic the effects of a powerfully anabolic banned substance provides a psychological incentive to many potential users, as does the attention drawn by the AFL "peptides" scandal of early 2013 and the subsequent report by the Australian Crime Commission .

The news that doping with custom peptides (such as AOD9604, CJC-1295, Sermorelin and Tesamorelin) is widespread in Australian sport has been all over the web. Cyclist, football league, Rugby league

Recently it has been widely reported that Essendon Football club players often nicked “The Essendon Bombers” were prescribed the anti-obesity drug AOD-9604 in the 2012 AFL season.  In the 2013 season the AFL claimed substances players may have taken in 2012 could still be aiding performance this year.

And the AFL also released circumstantial evidence alleging some Essendon players were given Thymosin Beta-4. The summary of charges against Essendon for bringing the game into disrepute said potential effects could last "many months or even up to a year or longer".Thymosin Beta-4 is listed as banned for use by all athletes under the strict S2 provisions of the WADA code.

The charges makes it clear substances like Thymosin Beta-4 can have long-lasting effects. It makes the same claim of Hexarelin, a substance allegedly brought into Essendon's Windy Hill headquarters by sports scientist Stephen Dank.

Whilst AOD9604 is not approved by the Australian TGA, it can be legally obtained on a doctor's prescription and dispensed by a compounding pharmacy. This is true of many experimental substances, but it does big favours for the reputation of AOD9604, giving the impression that, like other drugs issued by the medical profession, it is an efficacious and high quality product. These reasons, when considered together, give a powerful impression that peptides are highly effective

Metabolic Pharmaceuticals have reported that recent in vitro trials have shown that AOD9604 may stimulate the growth of bone cells, and muscle and cartilage cells. These results have not yet been reproduced in animals or humans .

Metabolic Pharmaceuticals' dreams came crashing down in 2007, when the company terminated development of the anti-obesity drug AOD9604 after spending about $60 million on development. At its peak, Metabolic ( renamed Calzada) captured the market's imagination and was capitalised at $500 million.

The company abandoned its weight-loss tablet after failing to establish efficacy in a large clinical trial. However, former Metabolic investors still lamenting lost fortunes may be interested in new anecdotal evidence that investors were let down not by the drug's lack of potential but by a management decision to focus exclusively on oral delivery in the belief that this was the only blockbuster market.

There was a lot of speculation that Metabolic was providing AOD9604 to players at the Essendon Football Club as part of a secret clinical trial, but the company has flatly denied this claim, claiming it has not run any human trials since 2007. AOD9604 has been scientifically proven safe and side-effect free, and is apparently very difficult to detect in the blood.

In 2010, the company heard word that bodybuilders were importing knock-off versions of the patent-protected peptide from China, and started licensing the manufacturing rights out to other companies in an attempt to compete, as this was determined to be a better course of action than attempting to sue the Chinese company for patent breach. Desperate to recoup this investment, they invested a small additional amount into developing a technology that allowed the peptide to be absorbed through the skin, in collaboration with a company called Phosphagenics. The peptide was then licensed for use in BodyShaper, an anti-cellulite cream. Phosphagenics later dropped AOD9604 from BodyShaper, citing excessive expense and ineffectiveness.

When the AFL Peptides scandal hit, Calzada was forced to clarify the facts about AOD9604, and put out a cleverly worded press statement aimed at potential investors, concentrating on the fact that AOD9604 had been proven safe in large scale clinical trials and spoke of the success of AOD9604 on stimulating bone growth, and on cartilage and muscle cell repair in in-vitro trials. The black market uses for this peptide in muscle repair and treatment of obesity were also mentioned in the release, and it is clear through media reports on this scandal that Calzada gained traction from the profile boost.

If there's one thing that science has definitively said about AOD9604, it is that it is safe and has no side effects. Calzada, after trying the peptide out as an anti-obesity and anti-arthritic, has succeeded in having the peptide declared "Generally regarded as safe" (GRAS) by the FDA, which makes it legal to use as a food additive in America. Calzada, seemingly under no pretense that their product has pharmaceutical properties, is now trying to break into the US over the counter supplement and "Nutraceutical" market with AOD9604. Interestingly, the compound has only been approved for use in levels of up to 1mg per day, whereas the doses used in trials generally hovered around 500ug/kg, which means a 100kg person was receiving 50mg of the peptide daily. There is no science behind the peptide, or the dosage, and Calzada themselves have previously said AOD9604 is not effective orally.

Biochemists are unsurprised that bodybuilders are achieving results where Metabolic's clinical studies failed. When taken as a tablet the AOD9604 peptide, like all peptides, is prone to being broken down in the stomach and intestine before it can be absorbed into the bloodstream.

It seems increasing numbers of bodybuilders are turning to blackmarket AOD9604, attracted by its fat-busting capabilities when injected directly into the abdomen.

Press coverage and word of mouth has generated quite a bit of hype around AOD9604. Despite its popularity on the black market, there is no research into the safety and effect of injecting this peptide at high doses. Intriguingly, it is not currently in Calzada's interest to fight the black market production of AOD9604, even though it is a patented product. Calzada lack the funds to legitimately boost the reputation of this peptide through clinical trials, and there is a strong chance these would once again prove that AOD9604 has no effect. The good reputation this peptide currently enjoys is likely to provide strong leverage to its marketing as a food supplement in the United States.

Whilst not illegal to buy AOD9604 in Australia, AOD9604 does not have approval by the TGA, which means it is not allowed to be sold on the basis of it having any pharmaceutical or performance enhancing benefits. It has not been approved by any pharmaceutical authority worldwide, except for the previously mentioned "Generally Regarded As Safe" designation by the FDA. AOD9604 is currently classed by the World Anti-Doping Agency (WADA) as a non-approved substance, which means it is not legal 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.

News of results achieved by body-builders comes after a recent announcement from Calzada that, after three years of inaction, it would once again be dedicating resources to generating value from the AOD9604 patents.

Calzada has about $11 million in the bank and trades at around cash backing. It may be a long-shot from here, but new management's challenge is to efficiently gather data on the efficacy of injectible AOD9604 before pursuing a licensing deal with a pharmaceutical company.