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PEPLUX

Modified growth hormone fragment

AOD-9604

Illustrative PEPLUX product vial in a purple-lit studio
Product illustration

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Subcutaneous injection

The process

Licensed provider review

AOD-9604 cost

$229 per month

*If medically eligible.
Medication
Included
Clinician visit
Included
Baseline labs
Included
Lab retests
Included when ordered by your provider
Shipping
Included
Patient portal access
Included
Care-team chat support
Included

Considering more than one product?

  • Two products prescribed together: $349 per month
  • Three products prescribed together: $479 per month
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Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

FDA status, checked on October 13, 2026

AOD-9604 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Order now

No compounding pathway today.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.

Prescription products require an online evaluation with a licensed provider. Not all patients qualify.

States served: not yet confirmed. How state availability works

What is AOD-9604?

AOD-9604, a modified fragment of human growth hormone. A different substance from hGH fragment 176-191; WADA lists them separately.

Adults who want to discuss AOD-9604 with a licensed provider and who understand that it is not FDA-approved and that the evidence in people is limited. Whether it is appropriate is a decision made with the prescriber after an evaluation, not a choice made from this page.

Key risks

  • AOD-9604 is not FDA-approved, and its safety in people has not been established.
  • FDA's safety page says compounded AOD-9604 may pose a significant risk of immunogenicity, an immune reaction to the peptide, and that little safety information is available.
All risks and who should not use it

FDA status

FDA status for AOD-9604.

Rendered from our regulatory records, which cite FDA, Federal Register and label documents directly. Each record shows the date we last checked it.

No compounding pathway today.

AOD-9604 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

AOD-9604

No compounding pathway today.

AOD-9604 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 on September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on December 4, 2024. Nothing favorable is pending.

Basis
FDA's 503A categories document of September 27, 2024 removed AOD-9604 from Category 2 after its nominations were withdrawn. At its December 4, 2024 meeting, FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against it, in one vote covering the free base and the acetate, according to the final minutes. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded AOD-9604 may pose a significant risk of immunogenicity, that FDA has identified no, or only limited, safety-related information, and that FDA has identified serious adverse events that may be associated with it, though causality is not clear.
Checked on
October 13, 2026

How it works

AOD-9604 mechanism.

AOD-9604 is a synthetic peptide modeled on the final stretch of the human growth hormone molecule, with one amino acid added at its start. Laboratory and animal research has studied its effects on fat-cell (lipid) metabolism, the activity attributed to that region of growth hormone.

That describes what the molecule does in the body. It is not a claim about what it will do for you.

What the evidence supports

AOD-9604: evidence and limitations.

The evidence comes mainly from laboratory and animal studies and from a limited number of human trials run during its development, and FDA has never approved it as a medicine. Its safety and effectiveness in people have not been established. In 2024 FDA's Pharmacy Compounding Advisory Committee voted against adding it to the 503A bulks list.

Risks

AOD-9604 risks and side effects.

  • AOD-9604 is not FDA-approved, and its safety in people has not been established.
  • FDA's safety page says compounded AOD-9604 may pose a significant risk of immunogenicity, an immune reaction to the peptide, and that little safety information is available.
  • FDA has also identified serious adverse events that may be associated with AOD-9604, although it says a causal link is not clear.
  • Reactions at the injection site are possible, as with any injected peptide.
  • There is no FDA label, so there is no formal list of contraindications. It should not be used after an allergic reaction to it, or during pregnancy or breastfeeding, where there are no safety data.

This information is educational and is not medical advice. It does not establish a provider–patient relationship.

Clinical review

What your prescriber will consider.

These are decision factors a licensed provider weighs when deciding whether this product is appropriate for you. They are not instructions, and there is no dosing protocol on this page.

  • Whether the reason for the request has had a standard medical evaluation, and which approved options have been considered

  • Prior allergic or immune reactions to peptide products, given FDA’s note on immunogenicity

  • Current medicines and any hormone treatment

  • Pregnancy, breastfeeding or plans to conceive

PEPLUX does not publish self-administration protocols. Dose, frequency and duration are set by your prescriber against your own history and reviewed over time.

Lot documents

What a certificate of analysis should cover.

When a pharmacy is named, each lot's certificate of analysis is expected to cover the tests below. No certificate exists or is published yet.

  • Potency
  • Sterility
  • Endotoxin
  • pH

Sport and anti-doping

Prohibited under the WADA code.

  • Prohibited at all times under WADA class S2.2.3 (growth hormone, its analogues and fragments).

If you compete under an anti-doping authority, or are tested through your employer or federation, tell your prescriber before you start. Sanctions can follow from possession or purchase records alone, without a positive test.

Straight answers

Common questions about AOD-9604.

What is the FDA status of AOD-9604?
No compounding pathway today. AOD-9604 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 on September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on December 4, 2024. Nothing favorable is pending. Checked against primary sources on October 13, 2026.
Is compounded AOD-9604 an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. AOD-9604 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
What does the evidence support for AOD-9604, and what does it not?
The evidence comes mainly from laboratory and animal studies and from a limited number of human trials run during its development, and FDA has never approved it as a medicine. Its safety and effectiveness in people have not been established. In 2024 FDA's Pharmacy Compounding Advisory Committee voted against adding it to the 503A bulks list.
What are the risks of AOD-9604?
AOD-9604 is not FDA-approved, and its safety in people has not been established. The full list of side effects, and of who should not use AOD-9604, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Does AOD-9604 require baseline labs?
No. AOD-9604 does not require baseline labs, though your prescriber may order them based on your history. Baseline labs are included in the price.
What does AOD-9604 cost?
$229 per month. Medication: included. Clinician visit: included. Baseline labs: included. Lab retests: included when ordered by your provider. Shipping: included. Patient portal access: included. Care-team chat support: included. *If medically eligible.
Is AOD-9604 prohibited in sport?
Prohibited at all times under WADA class S2.2.3 (growth hormone, its analogues and fragments). If you are subject to anti-doping testing, tell your prescriber before you start. Sanctions can follow from possession or purchase records alone, without a positive test.
How is AOD-9604 given?
Subcutaneous injection. Your prescriber decides whether it is appropriate for you and sets the regimen. PEPLUX does not publish dosing.

Next step

A licensed provider reviews every request.

AOD-9604 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Order now

No compounding pathway today.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

Also offered

Other products.

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