AOD-9604: where it stands with the FDA, and what it costs
No FDA-approved drug contains it.
Go to clinicLowest per monthAOD-9604 injection (10mg)
Pepti · $229/mo (≈ $245 per 30 days with its fees)
Where AOD-9604 stands today
No FDA-approved drug contains AOD-9604. FDA placed it in 503A Category 2 in September 2023 (it cites possible serious adverse events, causality unclear) and removed it in September 2024 after the nominations were withdrawn. On December 4, 2024 the advisory committee voted 0-12 against listing it. It is not on the 503A or 503B bulks list, not in any category, and not in HHS's October 2026 interim policy.
For pharmacies compounding one patient's prescription (section 503A)
Not in any 503A category and not on the 503A bulks list. Removed from Category 2 in September 2024 (nominations withdrawn); the advisory committee voted 0-12 against listing it (Dec 4, 2024); no final rule. Not in HHS's Oct 2026 interim policy.
“Bulk drug substances nominated but withdrawn ... AOD-9604 Compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has identified no, or only limited, safety-related information. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.”
““AOD-9604” has been removed from Category 2 because the nominations were withdrawn by the nominators.”
FDA interim 503A bulks policy: a substance outside Category 1 gets no interim enforcement discretion
“Drug products compounded using a bulk drug substance for which each of the above circumstances are not present are not within the scope of the policy described in this guidance.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The FDA's compounding advisory committee
4 December 2024: Should AOD-9604 (free base) and AOD-9604 acetate be placed on the 503A bulks list? (voted as a group). Vote: Yes 0, No 12, Abstain 0. Committee advised against listing; FDA has published no rule since
“a. VOTE: FDA is proposing that AOD-9604 (free base) and AOD-9604 acetate NOT be included on the 503A Bulks List. Should AOD-9604 (free base) and AOD-9604 acetate be placed on the list? Vote Result: Yes: 0 No: 12 Abstain: 0”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“growth hormone fragments, e.g. AOD-9604 and hGH 176-191”
Our reading
There is no current route to lawful 503A or 503B compounding of AOD-9604; a clinic offering it is relying on nothing in FDA's or HHS's enforcement policies.
Every source above was checked again on 14 November 2026.
What 5 clinics charge
- PeptiAOD-9604 injection (10mg)$229/mo≈ $245 per 30 days with its fees
- PeptiAOD-9604 injection (15mg)$259/mo≈ $278 per 30 days with its fees
What AOD-9604 is
- What it is
- Growth hormone fragment
- How it works
- A modified fragment of the end of human growth hormone, developed as a fat-loss drug that did not reach approval.
- How it is given
- Subcutaneous injection
- Also called
- hGH fragment 176-191
About AOD-9604
Is AOD-9604 FDA-approved?
No. No FDA-approved drug contains AOD-9604. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is AOD-9604 legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains AOD-9604. FDA placed it in 503A Category 2 in September 2023 (it cites possible serious adverse events, causality unclear) and removed it in September 2024 after the nominations were withdrawn. On December 4, 2024 the advisory committee voted 0-12 against listing it. It is not on the 503A or 503B bulks list, not in any category, and not in HHS's October 2026 interim policy.
How much does AOD-9604 cost?
5 clinics publish a price. The lowest that compares per month is $229/mo at Pepti. What a month buys differs by clinic, so each price lists what it includes. every AOD-9604 price
What forms does AOD-9604 come in?
Clinics sell it as injection (5 prices), other (1 price).