Sources checked October 21, 2026. FDA archive dates and the regulation's currency are identified below. This guide describes records and study measurements, not a treatment recommendation.
What is the difference between AOD-9604 and HGH?
AOD-9604 contains the human growth hormone segment numbered 177 through 191 plus an added tyrosine, rather than the entire hormone.[1] The 2013 human-study report identifies its amino acid sequence as YLRIVQCRSVEGSCGF.[1] A description that simply calls it HGH leaves out that structural distinction.
A later Lateral Pharma protocol identifies LAT8881 as the same peptide previously developed under the name AOD9604.[5] Searching only the older name misses the later pain-study records. That identity link does not make every commercial vial the formulation tested in those studies.
What is AOD-9604's FDA and compounding status?
FDA's November 2024 evaluation states that neither AOD-9604 free base nor its acetate form is a component of an FDA-approved drug.[2] The document evaluates both forms for the 503A compounding list and recommends against inclusion; that evaluation is not itself a final regulation.[2] The retrieved copy was archived October 5, 2026.
The codified inclusion list in 21 CFR 216.23, checked in the version current through October 19, 2026, does not list AOD-9604.[4] The regulation also says inclusion on that list is not FDA approval or endorsement of a compounded product.[4] Approval, a compounding-list entry and a committee evaluation are separate records.
FDA's separate table, archived October 11, 2026, places AOD-9604 among substances whose nominations were withdrawn after previously appearing in Category 2.[3] Calling that table entry a new approval, or describing it as an unchanged active Category 2 nomination, misses the table's stated status.[3] This dated record is not a determination about an individual pharmacy's current practice.
What have human AOD-9604 studies measured?
The following records separate the original obesity program from later LAT8881 pain studies. They are not a pooled estimate or a prediction for a patient. The later results are sponsor-submitted registry records, not independent reanalysis.
Earlier obesity studies: oral and intravenous routes
Stier and colleagues' 2013 report describes six placebo-controlled studies, including a 300-person, 12-week oral trial and a 502-person, 24-week oral trial.[1] Earlier intravenous studies involved single-dose exposures.[1] The report focused on safety measurements, including IGF-1, glucose tests and adverse-event collection, rather than a full weight-loss results report.[1] The authors disclosed company funding and financial or consulting relationships.[1]
OPTIONS: randomized enrollment is not screened enrollment
FDA's 2024 evaluation describes OPTIONS as a 24-week oral study with 502 randomized adults, alongside a diet and exercise program.[2] It reports no statistically significant weight-loss difference from placebo at the 12-week primary endpoint.[2] FDA cites the sponsor's February 21, 2007 announcement ending obesity development.[2] These findings are attributed to FDA's review; the original sponsor filing was not recovered for this guide.
The earlier report gives 534 enrolled, while FDA's account gives 536; both identify 502 randomized.[1][2] Those enrollment figures should not be silently substituted for the randomized population.
Oral LAT8881: a four-week crossover pain study
NCT03865953 enrolled 53 adults with diabetic peripheral neuropathy or postherpetic neuralgia.[6] Participants crossed between oral LAT8881 and placebo in four-week treatment periods separated by a three-week washout.[6] The posted primary analysis lists 50 participants per treatment period, not 100 distinct people.[6]
Mean pain-score changes were -0.87 with LAT8881 and -0.74 with placebo on a 0-to-10 scale.[6] The model-estimated difference was -0.14 points, with a 95% confidence interval from -0.76 to 0.49 and P=0.67.[6] These are pain measurements, not weight-loss outcomes.
Intravenous LAT8881: short-term lumbar pain measurements
NCT05298306 records 26 enrolled participants across two parts.[7] Its lumbar radicular pain crossover portion included 17 participants and measured pain through six hours after infusion started.[7] Enrollment in that portion closed after a planned interim analysis.[7]
At six hours, mean changes on the 0-to-10 visual analog scale were -1.2 with LAT8881 and -0.8 with placebo.[7] The adjusted difference was -0.15, with a 95% confidence interval from -0.92 to 0.61 and P=0.6892.[7] The adjusted estimate is not simple subtraction of those raw means. The 17 people are counted under both treatments because this was a crossover, not two independent groups.[7]
Do these studies describe injections offered by clinics?
The original program used oral and intravenous preparations.[1] FDA's 2024 evaluation reported that it had not identified human exposure data for the nominated subcutaneous or topical routes.[2] That is a dated finding about specific routes, not a claim that there have been no human AOD-9604 studies.
The later LAT8881 protocol describes intravenous administration and identifies the earlier AOD9604 development name.[5] Neither that protocol nor an oral study establishes the identity, dose or clinical outcome of a different product sold by a clinic. This guide does not supply a dosing chart or self-injection instructions.
What should you ask a peptide clinic?
Ask for the exact substance name and formulation, the proposed route, the prescriber's identity and license, and the dispensing pharmacy's name. Ask which study supports the specific proposal, rather than accepting a reference to peptide research in general.
Ask the provider to distinguish an FDA-approved product from a compounded preparation and to explain the applicable basis for offering it. Request a written description of consultation, laboratory, medication and follow-up charges. These are documentation questions, not a recommendation to use AOD-9604.
Where can you browse related clinic listings?
Regenerated.com's September 2026 export contains 2,743 Peptide Therapy records in a sample of 9,042 published clinic records, across 49 states plus Washington, DC. Source: Regenerated.com clinic export, September 2026. This is historical directory coverage, not a count of AOD-9604 prescribers, a product-availability check or the size of the US market.
Browse Peptide Therapy clinics, or compare listings in Florida Peptide Therapy clinics and Texas Peptide Therapy clinics. Confirm the named provider, service and location directly. Inclusion in the directory is not an endorsement.