Regulatory record
- April 2020
- FDA warns a Kentucky compounding pharmacy that drug products it compounded using AOD 9604 and twenty-one other substances are not eligible for the exemptions in section 503A(a).
- December 2024
- The Pharmacy Compounding Advisory Committee votes 0 in favor, 12 against, and 0 abstaining on whether AOD-9604 (free base) and AOD-9604 acetate should be placed on the 503A bulks list. FDA had proposed that neither be included; the committee took a single grouped vote by 12 to 0. The use evaluated was obesity.
- August 2026
- AOD-9604 appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding notes serious adverse events that may be associated with the substance, though causality is not clear.
Status verified for this index · August 2026
Definition
AOD-9604 is a synthetic fragment of human growth hormone corresponding to the C-terminal region of the molecule, prepared with an added tyrosine residue. It was developed on the hypothesis that the lipolytic activity of growth hormone could be separated from its effects on growth and glucose metabolism [1].
It reached commercial development as an anti-obesity candidate and is sold today as a fat-loss peptide. What separates it from most compounds in this index is that a sponsor once ran a program on it; what it shares with them is that almost none of that program reached the published literature.
Evidence
The foundational work is animal and mechanistic. A 2000 report described metabolic studies of the synthetic lipolytic domain in obese rodent models [1], and the compound subsequently became familiar to anti-doping laboratories, which developed methods to detect it and characterized its in vitro metabolism [2].
The published human record is empty in an unusual way. Across four name variants PubMed returns 27 indexed records in total, of which 21 carry the Humans subject heading, 0 the clinical-trial publication type, and 0 the randomized-controlled-trial type [3]. Twenty-seven records is small enough to read in full, and it was read in full: the set consists of rodent and cell work, doping-detection analytical chemistry, obesity-pipeline review articles, and three entries in a serial feature that lists development programs rather than reporting them. No primary report of a human trial of this compound is indexed [3].
The Humans heading on twenty-one of twenty-seven records is the reason this census had to be read rather than counted. It marks human tissue, human assays, and human doping-control samples. It does not mark a person who received the compound in a study whose results were published.
Lawful access
There is no lawful United States supply route. On December 4, 2024 the Pharmacy Compounding Advisory Committee voted 0 in favor, 12 against, and 0 abstaining on whether AOD-9604 (free base) and AOD-9604 acetate should be placed on the section 503A bulks list; FDA had proposed that neither be included, and the committee agreed by 12 votes to 0 to decide both substances in one vote. The use FDA evaluated was obesity [4].
The nomination was subsequently withdrawn. AOD-9604 now appears in FDA's table of substances nominated but withdrawn, and in no category of the 503A bulks list published on May 14, 2026 [5][6]. FDA's published finding is that compounded drugs containing it may pose a significant risk for immunogenicity, that the agency has identified no or only limited safety-related information, and that it has identified serious adverse events that may be associated with the substance, though causality is not clear [6].
In April 2020 FDA also warned a compounding pharmacy that products it compounded using AOD 9604 and twenty-one other substances were not eligible for the exemptions in section 503A(a) [7]. Material sold under this name is research-use-only chemical supply; the research-only page sets out what that position means.
Elsewhere in this index
Filed under
- Research-onlyNomination withdrawn
- Growth factor fragments2 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Reference tables
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- The human trial recordHow many human clinical trials exist for each peptide in this index?
Same class
- PEG-MGFNo lawful route
References
- Ng FM, Sun J, Sharma L, et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274–278. PMID 11146367
- Cox HD, Smeal SJ, Hughes CM, et al. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31–38. PMID 25208511
- PubMed, National Library of Medicine. Census run 2026-08-31 across four name variants — "AOD9604" OR "AOD-9604" OR "hGH fragment 176-191" OR "growth hormone fragment 176-191" — returning 27 indexed records in total, 21 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. All 27 records were retrieved and read individually: rodent and cell work, doping-detection analytical chemistry, obesity-pipeline review articles, and three entries in the serial feature "Gateways to clinical trials", which lists development programs rather than reporting results. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. Source
- US Food and Drug Administration. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024, questions 2, 2a and the accompanying table of uses evaluated. Read 2026-08-31. Source
- US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full 2026-08-31: AOD-9604 appears in none of Category 1, Category 2, or Category 3. Source
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for AOD-9604 in the table of substances nominated but withdrawn. Read 2026-08-31. Source
- US Food and Drug Administration. Warning letter, Tailor Made Compounding LLC, case 594743, April 1, 2020. Read 2026-08-31. Source