Regulatory status

Status at a glance

503A compounding status

Removed from Category 2 (review pending)

FDA has moved this substance out of Category 2 while it is reviewed further. Removal from Category 2 does not authorize compounding. Its status remains unsettled until FDA completes its evaluation.

Listed by FDA · FDA source document

FDA approval
Not FDA-approved for any use
503B outsourcing
Not determined
Anti-doping (WADA)
On the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

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Status as of

Key takeaway

AOD-9604 is a modified fragment of the tail end of human growth hormone, developed as a fat-loss drug. Its human obesity trials failed to beat placebo, and development for obesity was halted. As of 2026 it is not FDA-approved and is banned in sport.

At a glance

FDA status
Non-FDA-approved peptide
What it is
Modified fragment of the growth hormone molecule, studied for fat loss
Research
Human obesity trials did not beat placebo, and development was discontinued
Sport
Prohibited by WADA at all times
Evidence strength
Low research

Summary

AOD-9604 is a growth hormone fragment studied for fat loss. Human obesity trials failed to beat placebo, and it is not FDA-approved. See what research shows.

What is AOD-9604?

AOD-9604 is a synthetic peptide based on the C-terminal (tail) region of human growth hormone, with an added amino acid to stabilize it. The name stands for "Advanced Obesity Drug," reflecting its original development by Metabolic Pharmaceuticals as a weight-loss candidate. It is sold on the wellness and "research peptide" market for fat loss, often under the broader "hGH fragment 176-191" label, though it is a modified version of that fragment rather than the bare fragment.

How does it work?

The proposed idea is that the tail region of growth hormone carries its fat-burning activity without the rest of the hormone's effects. In animal and cell studies, AOD-9604 increased both fat breakdown and fat oxidation while it reduced fat storage, reportedly without activating the growth hormone receptor or causing growth or insulin-resistance effects. In rodents, it also raised markers of fat metabolism (here and here). These are animal and laboratory findings; the human trials below tested whether they translate.

Is it FDA-approved?

Safety note

Status: Non-FDA-approved peptide

Category: Wellness and performance · Primary body area: Digestive & weight

No. AOD-9604's regulatory status covers several points:

  • Not approved by the FDA for any use, and never reached market as a drug
  • A history that includes an attempt to position it as a food/supplement ingredient
  • Not an approved compounding substance
  • Prohibited at all times in sport under the WADA list, which covers growth hormone fragments including AOD-9604

What does the research show?

Editor’s note

Evidence strength: Low research

Its human obesity trials failed to beat placebo and development was halted, so there is no sound human evidence that it works for fat loss, despite more human testing than most peptides in this category.

Unusually for a wellness peptide, AOD-9604 was tested in real human trials, and they were negative. A 24-week Phase 2b obesity trial of 536 participants did not produce significant weight loss versus placebo, and development for obesity was terminated in 2007; an earlier, smaller signal did not replicate. The supporting mechanism data remain animal and cell-based. So the best human evidence does not support the marketed fat-loss use; it argues against it.

Sources: animal studies of the growth hormone fragment's fat-metabolism effects (Ng et al., Hormone Research, 2000, DOI: 10.1159/000053183; Heffernan et al., International Journal of Obesity, 2001, DOI: 10.1038/sj.ijo.0801740), indexed on PubMed; reporting on the discontinued obesity program; and the WADA Prohibited List. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

Sources

  1. [1]
  2. [2]
  3. [3]
  4. [4]

    amino acids 177 to 191

    Primary PubMed

  5. [5]

    191 amino acids of full-length hGH

    Primary dailymed.nlm.nih.gov

  6. [6]
  7. [7]

    substances that may present significant safety risks

    Primary U.S. Food and Drug Administration

  8. [8]

    WADA Prohibited List (PDF)

    Primary World Anti-Doping Agency

  9. [9]

    Category 1

    Primary U.S. Food and Drug Administration

  10. [10]

    FDA approval

    Primary U.S. Food and Drug Administration

  11. [11]

    2007 NEJM study

    Primary PubMed

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