Thinking about trying AOD-9604 for weight loss? You’ve probably seen conflicting information about whether it’s FDA-approved. Let’s clear this up once and for all: AOD-9604 is not FDA-approved for any medical purpose. It never has been.
Despite what you might see on some websites claiming “GRAS status” or regulatory approval, AOD-9604 remains an investigational compound. Development was discontinued in 2007 after clinical trials failed to show significant weight loss benefits. Here’s the complete regulatory story.
What Is AOD-9604?
AOD-9604 stands for Anti-Obesity Drug compound 9604. It’s a synthetic peptide fragment derived from human growth hormone (specifically amino acids 177-191). Australian researchers developed it in the 1990s as a potential anti-obesity medication.
The peptide was designed to mimic growth hormone’s fat-burning effects without triggering the hormone’s other actions. The goal was creating a weight loss drug with fewer side effects than full-length growth hormone.
For a while, it looked promising. Early trials showed some potential. Pharmaceutical company Metabolic Pharmaceuticals invested heavily in its development. Then the larger trials happened.
The FDA Approval Process – What AOD-9604 Didn’t Pass
Understanding why AOD-9604 isn’t FDA-approved requires understanding what FDA approval actually means.
Clinical Trial Requirements
For FDA approval, a drug must pass through rigorous clinical testing:
Phase I trials test safety in small groups
Phase II trials test efficacy and dosing in larger groups
Phase III trials compare the drug to existing treatments in thousands of patients
If successful, the manufacturer submits a New Drug Application (NDA)
The FDA reviews all data and decides whether to approve
AOD-9604 made it through Phases I and II. Phase III is where it failed.
The Critical Phase III Failure
In 2007, development was terminated after the pivotal Phase III trial. This 24-week study enrolled 536 obese subjects and compared daily AOD-9604 injections to placebo.
The results? Disappointing. AOD-9604 did not induce significant weight loss compared to placebo. The difference existed but fell within statistical error margins. For a weight loss drug to get approval, it needs to demonstrate clear, clinically meaningful benefits. AOD-9604 didn’t meet that threshold.
After this failure, Metabolic Pharmaceuticals discontinued development. No NDA was ever submitted to the FDA. Without an NDA, there can be no approval.
Current FDA Status in 2025
Fast forward to today. Where does AOD-9604 stand with U.S. regulators?
Not Approved for Any Indication
AOD-9604 lacks FDA approval for weight loss, obesity treatment, or any other medical condition. It’s classified as an investigational new drug (IND) at best. More accurately, it’s a discontinued research peptide with relevance confined to academic exploration.
Not on the 503A Bulks List
In December 2024, the FDA made an important determination. They decided that AOD-9604 (both free base and acetate forms) should not be included on the 503A Bulks List for pharmaceutical compounding.
This matters because the 503A Bulks List determines which substances compounding pharmacies can legally use. The FDA cited several concerns:
Limited long-term safety data
Potential peptide impurities
Risk of immunogenicity (immune system reactions)
Lack of demonstrated efficacy in rigorous trials
This decision makes it harder for compounding pharmacies to legally provide AOD-9604, though some may still offer it under specific circumstances.
WADA Prohibited Status
The World Anti-Doping Agency (WADA) lists AOD-9604 as a prohibited substance under “S2 Peptide Hormones, Growth Factors, and Related Substances.” Competitive athletes cannot use it without facing sanctions.
This ban doesn’t make it illegal for general public use, but it signals that regulatory bodies view it as a performance-enhancing substance lacking proper approval.
International Regulatory Status
It’s not just the FDA. Other major regulatory bodies have also declined to approve AOD-9604.
European Medicines Agency (EMA)
The EMA, which regulates drugs in the European Union, has not approved AOD-9604. It remains unavailable as a prescription medication throughout Europe.
Therapeutic Goods Administration (TGA) – Australia
Ironically, even Australia – where AOD-9604 was developed – hasn’t approved it for therapeutic use. The TGA has issued warnings about unlicensed peptide products including AOD-9604.
Health Canada
Canada’s regulatory agency has not approved AOD-9604 for any indication. It’s not available through legitimate Canadian pharmacies.
Why the Confusion About FDA Approval?
If AOD-9604 clearly isn’t FDA-approved, why do some websites claim otherwise?
Misleading GRAS Claims
Some vendors claim AOD-9604 has “GRAS status” (Generally Recognized as Safe). This is misleading. GRAS status applies to food ingredients and dietary supplements, not pharmaceutical peptides. Even if it were GRAS (which it isn’t), that wouldn’t equal FDA approval as a drug.
Confusion with Other Peptides
Some FDA-approved medications contain peptides. Examples include insulin, exenatide (for diabetes), and teriparatide (for osteoporosis). People sometimes assume all peptides have similar approval status. They don’t.
Compounding Pharmacy Gray Area
Until December 2024’s ruling, some compounding pharmacies offered AOD-9604 under physician supervision. This created confusion – if my doctor prescribed it and a pharmacy filled it, surely it’s approved? Not necessarily. Compounding pharmacies can create medications from bulk substances that aren’t individually FDA-approved, though regulations have tightened considerably.
How People Access AOD-9604 in 2025
If it’s not approved, how are people getting it? Several routes exist, each with different legal and safety implications.
Research Chemical Vendors
Many online vendors sell AOD-9604 as a “research chemical” with disclaimers like “not for human use” and “research purposes only.” These products aren’t regulated for quality, purity, or sterility. You’re taking significant risks with unknown formulations.
Compounding Pharmacies (Limited)
Some compounding pharmacies may still offer AOD-9604 under specific circumstances, though the December 2024 FDA determination makes this more difficult. Doctors must justify compounding based on individual patient needs. This is becoming increasingly rare.
International Sources
Some people import AOD-9604 from countries with less stringent regulations. This carries legal risks (customs seizure) and safety risks (unknown product quality). The FDA can seize international shipments of unapproved drugs.
Safety Concerns Without FDA Oversight
The lack of FDA approval means several important safeguards don’t exist.
No Quality Standards
FDA-approved drugs must meet strict manufacturing standards (Good Manufacturing Practices or GMP). Without approval, there are no enforceable quality requirements. Purity, potency, and sterility vary wildly between vendors.
Limited Safety Monitoring
Approved drugs have post-market surveillance systems that track adverse events. If problems emerge, the FDA can require label changes or even pull the drug from the market. With AOD-9604, no such system exists. You’re on your own if something goes wrong.
No Dosing Guidance
FDA approval comes with detailed dosing information based on clinical trials. Without approval, dosing recommendations for AOD-9604 are based on discontinued research protocols and anecdotal reports. There’s no authoritative guidance.
Frequently Asked Questions
Will AOD-9604 ever be FDA-approved?
Unlikely. The compound failed Phase III trials and development was discontinued in 2007. For approval to happen, a pharmaceutical company would need to invest millions in new clinical trials. Given the previous failure and availability of better weight loss drugs, this seems improbable.
Can my doctor prescribe AOD-9604?
Doctors can prescribe unapproved medications in some circumstances (off-label use). However, with the December 2024 FDA determination removing it from compounding pharmacy lists, finding a pharmacy to fill such a prescription is increasingly difficult.
Is it illegal to buy or use AOD-9604?
It’s a gray area. Possessing AOD-9604 for personal use isn’t explicitly illegal in most jurisdictions. However, selling it for human use without FDA approval violates federal law. Vendors get around this by marketing it “for research only.”
What does “research purposes only” actually mean?
It’s a legal disclaimer that theoretically protects vendors from FDA enforcement. The implication is you’re buying it for laboratory research, not personal use. In practice, most buyers use it personally. This creates legal ambiguity that protects neither party effectively.
How is AOD-9604 different from FDA-approved weight loss drugs?
FDA-approved weight loss medications have proven efficacy in large trials, established safety profiles, quality controls, and clear dosing guidelines. AOD-9604 has none of these advantages. It’s an interesting research compound that failed clinical development.
Are there any FDA-approved alternatives to AOD-9604?
Yes. Several weight loss medications have FDA approval including GLP-1 receptor agonists (like GLP1-S), phentermine, orlistat, and naltrexone/bupropion combinations. These offer proven efficacy with regulatory oversight.
What happens if I have a bad reaction to AOD-9604?
You’re largely on your own. There’s no manufacturer to report to, no FDA adverse event system, and no recourse for product liability. Healthcare providers may be unfamiliar with treating complications from unapproved peptides.
Why did the FDA specifically exclude AOD-9604 from compounding?
The December 2024 decision cited safety concerns including limited long-term data, potential impurities, and immunogenicity risks. The FDA essentially determined the risk-benefit ratio doesn’t support making it widely available through compounding.
If it’s not approved, why do some doctors recommend it?
Some practitioners operate in the “anti-aging” or “wellness” space where unapproved peptides are common. They may believe clinical trial results don’t capture real-world benefits, or they may be financially incentivized to recommend these products. Use caution with such providers.
Could I use AOD-9604 if I’m a competitive athlete?
No. WADA prohibits it. Using AOD-9604 as a competitive athlete risks sanctions including bans and stripped titles. The prohibition exists regardless of whether you’re using it for performance enhancement or weight loss.
The Bottom Line
AOD-9604 is not FDA-approved and likely never will be. It failed Phase III clinical trials in 2007, leading to discontinued development. No major regulatory body worldwide has approved it for any medical use.
The December 2024 FDA determination further restricted access by excluding it from pharmaceutical compounding lists. While some vendors still sell it as a “research chemical,” you’re accepting significant risks: unknown product quality, no safety monitoring, and questionable legality.
If you’re serious about weight loss, work with your doctor to explore FDA-approved options. These offer proven efficacy, quality controls, and legal protections that AOD-9604 simply doesn’t have. The regulatory system exists for good reasons – mainly to protect you from ineffective or dangerous products.
For research purposes only, AOD-9604 and FDA-monitored alternatives like GLP1-S, GLP2-T, and GLP3-R are available at OathPeptides.com.
Disclaimer: All peptides, including AOD-9604, are strictly for research purposes and not for human consumption or use. This information is for educational purposes only and should not be considered medical advice. The use of GLP1-S, GLP2-T, and GLP3-R terminology refers to research compounds and not pharmaceutical medications. AOD-9604 is not FDA-approved for any use. Always consult healthcare professionals before pursuing any peptide research protocol.
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Is AOD-9604 FDA Approved? Current Status
Thinking about trying AOD-9604 for weight loss? You’ve probably seen conflicting information about whether it’s FDA-approved. Let’s clear this up once and for all: AOD-9604 is not FDA-approved for any medical purpose. It never has been.
Despite what you might see on some websites claiming “GRAS status” or regulatory approval, AOD-9604 remains an investigational compound. Development was discontinued in 2007 after clinical trials failed to show significant weight loss benefits. Here’s the complete regulatory story.
What Is AOD-9604?
AOD-9604 stands for Anti-Obesity Drug compound 9604. It’s a synthetic peptide fragment derived from human growth hormone (specifically amino acids 177-191). Australian researchers developed it in the 1990s as a potential anti-obesity medication.
The peptide was designed to mimic growth hormone’s fat-burning effects without triggering the hormone’s other actions. The goal was creating a weight loss drug with fewer side effects than full-length growth hormone.
For a while, it looked promising. Early trials showed some potential. Pharmaceutical company Metabolic Pharmaceuticals invested heavily in its development. Then the larger trials happened.
The FDA Approval Process – What AOD-9604 Didn’t Pass
Understanding why AOD-9604 isn’t FDA-approved requires understanding what FDA approval actually means.
Clinical Trial Requirements
For FDA approval, a drug must pass through rigorous clinical testing:
AOD-9604 made it through Phases I and II. Phase III is where it failed.
The Critical Phase III Failure
In 2007, development was terminated after the pivotal Phase III trial. This 24-week study enrolled 536 obese subjects and compared daily AOD-9604 injections to placebo.
The results? Disappointing. AOD-9604 did not induce significant weight loss compared to placebo. The difference existed but fell within statistical error margins. For a weight loss drug to get approval, it needs to demonstrate clear, clinically meaningful benefits. AOD-9604 didn’t meet that threshold.
After this failure, Metabolic Pharmaceuticals discontinued development. No NDA was ever submitted to the FDA. Without an NDA, there can be no approval.
Current FDA Status in 2025
Fast forward to today. Where does AOD-9604 stand with U.S. regulators?
Not Approved for Any Indication
AOD-9604 lacks FDA approval for weight loss, obesity treatment, or any other medical condition. It’s classified as an investigational new drug (IND) at best. More accurately, it’s a discontinued research peptide with relevance confined to academic exploration.
Not on the 503A Bulks List
In December 2024, the FDA made an important determination. They decided that AOD-9604 (both free base and acetate forms) should not be included on the 503A Bulks List for pharmaceutical compounding.
This matters because the 503A Bulks List determines which substances compounding pharmacies can legally use. The FDA cited several concerns:
This decision makes it harder for compounding pharmacies to legally provide AOD-9604, though some may still offer it under specific circumstances.
WADA Prohibited Status
The World Anti-Doping Agency (WADA) lists AOD-9604 as a prohibited substance under “S2 Peptide Hormones, Growth Factors, and Related Substances.” Competitive athletes cannot use it without facing sanctions.
This ban doesn’t make it illegal for general public use, but it signals that regulatory bodies view it as a performance-enhancing substance lacking proper approval.
International Regulatory Status
It’s not just the FDA. Other major regulatory bodies have also declined to approve AOD-9604.
European Medicines Agency (EMA)
The EMA, which regulates drugs in the European Union, has not approved AOD-9604. It remains unavailable as a prescription medication throughout Europe.
Therapeutic Goods Administration (TGA) – Australia
Ironically, even Australia – where AOD-9604 was developed – hasn’t approved it for therapeutic use. The TGA has issued warnings about unlicensed peptide products including AOD-9604.
Health Canada
Canada’s regulatory agency has not approved AOD-9604 for any indication. It’s not available through legitimate Canadian pharmacies.
Why the Confusion About FDA Approval?
If AOD-9604 clearly isn’t FDA-approved, why do some websites claim otherwise?
Misleading GRAS Claims
Some vendors claim AOD-9604 has “GRAS status” (Generally Recognized as Safe). This is misleading. GRAS status applies to food ingredients and dietary supplements, not pharmaceutical peptides. Even if it were GRAS (which it isn’t), that wouldn’t equal FDA approval as a drug.
Confusion with Other Peptides
Some FDA-approved medications contain peptides. Examples include insulin, exenatide (for diabetes), and teriparatide (for osteoporosis). People sometimes assume all peptides have similar approval status. They don’t.
Compounding Pharmacy Gray Area
Until December 2024’s ruling, some compounding pharmacies offered AOD-9604 under physician supervision. This created confusion – if my doctor prescribed it and a pharmacy filled it, surely it’s approved? Not necessarily. Compounding pharmacies can create medications from bulk substances that aren’t individually FDA-approved, though regulations have tightened considerably.
How People Access AOD-9604 in 2025
If it’s not approved, how are people getting it? Several routes exist, each with different legal and safety implications.
Research Chemical Vendors
Many online vendors sell AOD-9604 as a “research chemical” with disclaimers like “not for human use” and “research purposes only.” These products aren’t regulated for quality, purity, or sterility. You’re taking significant risks with unknown formulations.
Compounding Pharmacies (Limited)
Some compounding pharmacies may still offer AOD-9604 under specific circumstances, though the December 2024 FDA determination makes this more difficult. Doctors must justify compounding based on individual patient needs. This is becoming increasingly rare.
International Sources
Some people import AOD-9604 from countries with less stringent regulations. This carries legal risks (customs seizure) and safety risks (unknown product quality). The FDA can seize international shipments of unapproved drugs.
Safety Concerns Without FDA Oversight
The lack of FDA approval means several important safeguards don’t exist.
No Quality Standards
FDA-approved drugs must meet strict manufacturing standards (Good Manufacturing Practices or GMP). Without approval, there are no enforceable quality requirements. Purity, potency, and sterility vary wildly between vendors.
Limited Safety Monitoring
Approved drugs have post-market surveillance systems that track adverse events. If problems emerge, the FDA can require label changes or even pull the drug from the market. With AOD-9604, no such system exists. You’re on your own if something goes wrong.
No Dosing Guidance
FDA approval comes with detailed dosing information based on clinical trials. Without approval, dosing recommendations for AOD-9604 are based on discontinued research protocols and anecdotal reports. There’s no authoritative guidance.
Frequently Asked Questions
Will AOD-9604 ever be FDA-approved?
Unlikely. The compound failed Phase III trials and development was discontinued in 2007. For approval to happen, a pharmaceutical company would need to invest millions in new clinical trials. Given the previous failure and availability of better weight loss drugs, this seems improbable.
Can my doctor prescribe AOD-9604?
Doctors can prescribe unapproved medications in some circumstances (off-label use). However, with the December 2024 FDA determination removing it from compounding pharmacy lists, finding a pharmacy to fill such a prescription is increasingly difficult.
Is it illegal to buy or use AOD-9604?
It’s a gray area. Possessing AOD-9604 for personal use isn’t explicitly illegal in most jurisdictions. However, selling it for human use without FDA approval violates federal law. Vendors get around this by marketing it “for research only.”
What does “research purposes only” actually mean?
It’s a legal disclaimer that theoretically protects vendors from FDA enforcement. The implication is you’re buying it for laboratory research, not personal use. In practice, most buyers use it personally. This creates legal ambiguity that protects neither party effectively.
How is AOD-9604 different from FDA-approved weight loss drugs?
FDA-approved weight loss medications have proven efficacy in large trials, established safety profiles, quality controls, and clear dosing guidelines. AOD-9604 has none of these advantages. It’s an interesting research compound that failed clinical development.
Are there any FDA-approved alternatives to AOD-9604?
Yes. Several weight loss medications have FDA approval including GLP-1 receptor agonists (like GLP1-S), phentermine, orlistat, and naltrexone/bupropion combinations. These offer proven efficacy with regulatory oversight.
What happens if I have a bad reaction to AOD-9604?
You’re largely on your own. There’s no manufacturer to report to, no FDA adverse event system, and no recourse for product liability. Healthcare providers may be unfamiliar with treating complications from unapproved peptides.
Why did the FDA specifically exclude AOD-9604 from compounding?
The December 2024 decision cited safety concerns including limited long-term data, potential impurities, and immunogenicity risks. The FDA essentially determined the risk-benefit ratio doesn’t support making it widely available through compounding.
If it’s not approved, why do some doctors recommend it?
Some practitioners operate in the “anti-aging” or “wellness” space where unapproved peptides are common. They may believe clinical trial results don’t capture real-world benefits, or they may be financially incentivized to recommend these products. Use caution with such providers.
Could I use AOD-9604 if I’m a competitive athlete?
No. WADA prohibits it. Using AOD-9604 as a competitive athlete risks sanctions including bans and stripped titles. The prohibition exists regardless of whether you’re using it for performance enhancement or weight loss.
The Bottom Line
AOD-9604 is not FDA-approved and likely never will be. It failed Phase III clinical trials in 2007, leading to discontinued development. No major regulatory body worldwide has approved it for any medical use.
The December 2024 FDA determination further restricted access by excluding it from pharmaceutical compounding lists. While some vendors still sell it as a “research chemical,” you’re accepting significant risks: unknown product quality, no safety monitoring, and questionable legality.
If you’re serious about weight loss, work with your doctor to explore FDA-approved options. These offer proven efficacy, quality controls, and legal protections that AOD-9604 simply doesn’t have. The regulatory system exists for good reasons – mainly to protect you from ineffective or dangerous products.
For research purposes only, AOD-9604 and FDA-monitored alternatives like GLP1-S, GLP2-T, and GLP3-R are available at OathPeptides.com.
Disclaimer: All peptides, including AOD-9604, are strictly for research purposes and not for human consumption or use. This information is for educational purposes only and should not be considered medical advice. The use of GLP1-S, GLP2-T, and GLP3-R terminology refers to research compounds and not pharmaceutical medications. AOD-9604 is not FDA-approved for any use. Always consult healthcare professionals before pursuing any peptide research protocol.
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