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AOD-9604 vs tesamorelin

D AOD-9604 Modified hGH C-terminal fragment; lipolytic, does not bind the GH receptor Not FDA-approved · FDA compounding nomination withdrawn A Tesamorelin GHRH (growth-hormone-releasing factor) analog FDA-approved — Egrifta (2010)

Residue Editorial Team · updated

In brief

Both are linked to fat loss, on very different evidence. Tesamorelin is an FDA-approved GHRH analog (Egrifta) that reduced visceral fat by 15.4% versus placebo in pooled phase 3 trials of people with HIV1PubMedEffects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. Falutz J et al. J Clin Endocrinol Metab. 2010.,2FDAEGRIFTA SV prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2026-07-29.. AOD-9604 is a modified fragment of growth hormone's C-terminal region; its published efficacy data come from obese rodents3PubMedIncrease of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Heffernan MA et al. Int J Obes Relat Metab Disord. 2001.,4PubMedMetabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Ng FM et al. Horm Res. 2000., and it is not FDA-approved5FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..

How do AOD-9604 and Tesamorelin compare at a glance?

Table 1. AOD-9604 and Tesamorelin on the dimensions that matter most; every entry is cited.
DimensionAOD-9604Tesamorelin
What it isModified hGH C-terminal fragment3GHRH analog2
MechanismLipolytic; does not bind the GH receptor; needs β3-adrenergic receptors in mice3,6PubMedThe effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Heffernan M et al. Endocrinology. 2001.Stimulates pituitary GH release; raises IGF-11
Best evidenceRodent studies4Two phase 3 RCTs, pooled1
Human resultsPhase IIa reported underway in 2002; no results indexed7PubMedAOD-9604 Metabolic. Wilding J Curr Opin Investig Drugs. 2004.Visceral fat −24 cm² vs +2 cm² at 26 wk1
FDAWithdrawn nomination; serious adverse events listed5Approved: Egrifta; not indicated for weight loss2
Evidence gradeDA

Written by Residue Editorial Team

Reviewed by Residue Editorial Team · source-by-source check,

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Registry data · How we grade · Markdown + sources

Figure 1. Size of the research record, from PubMed and ClinicalTrials.gov at the data edition. Bars are scaled to the larger value in each row; volume is not quality.
PubMed records 22 105
Trial publications 0 24
Registered studies 0 24
Phase 3 studies 0 2

AOD-9604 Tesamorelin

How are the two molecules different?

Tesamorelin works upstream of growth hormone: as a GHRH analog it prompts the pituitary to release GH, and in pooled phase 3 data mean IGF-1 rose 108 ng/mL versus a 7 ng/mL fall on placebo1. AOD-9604 works downstream: it is an analog of the lipolytic C-terminal region of human GH that does not bind the GH receptor3.

What did animal studies of AOD-9604 find?

In obese Zucker rats, oral AOD-9604 at 500 µg/kg for 19 days cut body-weight gain by more than half compared with controls without impairing insulin sensitivity4. In obese mice, both hGH and AOD-9604 reduced weight gain and raised fat oxidation, but only hGH caused hyperglycemia3. The effect failed in β3-adrenergic-receptor knockout mice6.

What did human trials of tesamorelin find?

Two phase 3 trials in people with HIV and abdominal fat accumulation, pooled, showed visceral adipose tissue falling 24 cm² versus a 2 cm² rise with placebo at 26 weeks — a −15.4% treatment effect — without significant change in subcutaneous fat1. The effect persisted to 52 weeks but reversed after stopping8PubMedLong-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. Falutz J et al. AIDS. 2008..

Are they FDA-approved?

Tesamorelin is approved as Egrifta9FDADrugs@FDA: EGRIFTA (BLA022505). THERATECHNOLOGIES; original approval 2010-11-10; Prescription.; its label notes long-term cardiovascular safety has not been established2. FDA lists AOD-9604 among withdrawn compounding nominations5.

Two identical glass beakers, one holding pale amber liquid and one clear, standing either side of a brass balance

Why do they get these evidence grades?

D AOD-9604
All peer-reviewed efficacy data we found are from rats and mice. A phase IIa program was reported underway in 2002, but no results are indexed in PubMed. Grade D: Preclinical only.
A Tesamorelin
FDA-approved (Egrifta) for excess abdominal fat in HIV-associated lipodystrophy, based on two phase 3 trials. Other uses are graded separately. Grade A: Approved / regulatory-grade.

Questions readers ask

Is tesamorelin a weight-loss drug?

No. Its label limits the indication to excess abdominal fat in HIV-infected adults with lipodystrophy and states it is not indicated for weight-loss management2.

Has AOD-9604 been tested in humans?

A 2004 development profile reported phase IIa trials underway by February 20027, but we found no published results in PubMed.

Does AOD-9604 act like growth hormone?

In obese mice it reduced weight gain and increased fat oxidation like hGH, but it did not cause hyperglycemia, did not compete for the hGH receptor and did not induce cell proliferation3.

Can you take AOD-9604 and tesamorelin together?

No published trial among the sources we cite tested them together. Tesamorelin is FDA-approved for a labeled HIV-lipodystrophy use2; AOD-9604 is not approved5.

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

  1. 1 PubMed Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab 2010. PMID 20554713; doi:10.1210/jc.2010-0490.
  2. 2 FDA EGRIFTA SV prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2026-07-29.
  3. 3 PubMed Heffernan MA, Thorburn AW, Fam B, et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Int J Obes Relat Metab Disord 2001. PMID 11673763; doi:10.1038/sj.ijo.0801740.
  4. 4 PubMed Ng FM, Sun J, Sharma L, et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res 2000. PMID 11146367; doi:10.1159/000053183.
  5. 5 FDA Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026.
  6. 6 PubMed Heffernan M, Summers RJ, Thorburn A, et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Endocrinology 2001. PMID 11713213; doi:10.1210/endo.142.12.8522.
  7. 7 PubMed Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs 2004. PMID 15134286.
  8. 8 PubMed Falutz J, Allas S, Mamputu JC, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS 2008. PMID 18690162; doi:10.1097/QAD.0b013e32830a5058.
  9. 9 FDA Drugs@FDA: EGRIFTA (BLA022505). THERATECHNOLOGIES; original approval 2010-11-10; Prescription.