AOD-9604 vs Tesamorelin: differences, evidence and safety
Answer first
AOD-9604 is a piece of growth hormone that releases nothing. Its largest trial and three pain trials missed their targets, and no approval could be found. Tesamorelin copies the brain hormone that makes the pituitary gland release growth hormone. It is a US prescription medicine for belly fat in adults with HIV and lipodystrophy. No direct comparison could be found.
At a glance
How they work
Both substances are linked to growth hormone, and both are often filed under fat loss. They sit at opposite ends of the same hormone chain.
AOD-9604
- It is a chain of sixteen building blocks cut from the tail end of human growth hormone. A small ring joins its two cysteines. An extra tyrosine at the front was added for stability [1], [2].
- The idea was to keep the fat-breaking part of the hormone and drop the rest. The proposal is that it speeds up the breakdown of stored fat, but that evidence comes from obese mice and rats [3], [4].
- It does not switch on the growth hormone receptor. In laboratory tests it neither competed with growth hormone for that receptor nor made cells divide [3].
Tesamorelin
- It is a chain of 44 building blocks, a full copy of growth hormone releasing hormone. A small six-carbon group (a hexenoyl group) at the front end slows its breakdown [5].
- It binds to the docking points for that hormone on the pituitary gland, which then releases growth hormone in its normal pulses [5].
- Growth hormone acts partly through IGF-1, a messenger made mainly in the liver. In patients, the treatment raised IGF-1 and its carrier protein IGFBP-3 [5].
The core difference is the step in the chain. Tesamorelin works one step before growth hormone and makes the body release its own. AOD-9604 is a piece of the hormone itself and releases nothing [6].
What the studies show
No study that compares AOD-9604 and tesamorelin directly could be found in the published record reviewed for this page. The results below come from separate studies, in different people.
Fat: what each programme set out to change
Phase 2b RCT AOD-9604 was developed for obesity. The decisive trial enrolled 534 adults with obesity and randomised 502 of them at sixteen Australian hospitals and centres, for 24 weeks [2].
It missed its weight target. In 2007 the sponsor told the Australian stock exchange that the results did not support the commercial viability of the project. It then terminated the programme [7].
Phase 2b RCT The exact weight figures could not be found in any published report. The 2013 safety paper deliberately reports none of them [2]. A 2026 review notes that the negative verdict therefore rests on the sponsor's own announcement, not on a peer-reviewed efficacy report [6].
Phase 3 RCT Tesamorelin was tested on deep belly fat in adults with HIV and lipodystrophy. In this condition, body fat is redistributed in an unusual way. The first approval trial randomised 412 adults for 26 weeks.
Measured by scan, the deep fat around the organs (visceral fat) fell by 15.2 per cent on treatment. It rose by 5.0 per cent on placebo (p < 0.001) [8]. The label reports the difference as 31 square centimetres, or 20 per cent [5].
Phase 3 RCT The second trial followed 404 adults for six months. The deep fat fell by 10.9 per cent, against 0.6 per cent on placebo. Fat on the arms and legs did not change, and neither did the fat just under the skin of the belly [9].
Body weight
Phase 3 RCT Tesamorelin changed where fat sits, not how much a person weighs. Average body weight moved by −0.4 kg in the first approval trial and +0.5 kg in the second, neither different from placebo [5].
Its label states that it is not indicated for weight-loss management, because its effect on weight is neutral [5]. In the trials reviewed for this page, neither substance lowered body weight in people. AOD-9604 missed its target, and tesamorelin left weight unchanged.
IGF-1: the clearest difference in the trials
Phase 3 RCT In the first tesamorelin approval trial, IGF-1 rose by 81 per cent. It fell by 5 per cent on placebo (p < 0.001) [8].
Phase 2b RCT In the 24-week AOD-9604 trial, IGF-1 did not move. The average change was 1.76 nanomoles per litre at twelve weeks and 1.24 at 24 weeks. The groups did not differ (p = 0.50844 and p = 0.75754) [2].
Blood sugar
Phase 2b RCT In the same AOD-9604 trial, fasting glucose held steady. It changed by −0.02 units at twelve weeks (p = 0.73488) and by 0.04 units at 24 weeks (p = 0.62787) [2].
Phase 3 RCT For tesamorelin, the label records a rise. By week 26, long-term blood sugar had reached 6.5 per cent or more in 5 per cent of those treated. On placebo it was 1 per cent [5].
Other questions each was tested on
Phase 2 RCT AOD-9604 was later tested for pain, under the code LAT-8881. Nerve pain in 53 adults missed by a wide margin (p = 0.67) [10]. Migraine in 21 adults came closest at two hours (p = 0.1488) [11]. Back and leg pain in 26 people missed at all twelve time points (best p = 0.3983) [12].
RCT Tesamorelin was tested on liver fat in 61 people with HIV whose liver fat was at least 5 per cent. Twelve months lowered that fraction by 4.1 percentage points more than placebo, a relative fall of 37 per cent [13].
Phase 2 RCT An academic trial gave tesamorelin to 152 adults aged 55 to 87, average age 68, for 20 weeks. It found a favourable overall effect on thinking (p = 0.03), mainly in planning and mental flexibility [14].
Phase 2 RCT A later trial in 73 people with HIV found no difference between the groups (p = 0.673) [15]. None of these uses is approved.
Animal results for AOD-9604
Animal data Obese Zucker rats given AOD-9604 by mouth for nineteen days gained 15.8 grams, against 35.6 grams in the controls [4]. These results did not carry over to the human trial.
What happens after stopping tesamorelin
Phase 3 RCT In the extension phase, 263 participants were randomised again for a further 26 weeks. Those who stayed on tesamorelin held the reduction at 18 per cent below their starting point. Those switched to placebo lost the gains, and the deep fat accumulated again [16].
How long each stays in the body
Phase 1 For AOD-9604, the only published human pharmacokinetics come from infusions into a vein. Across three dose groups, peak blood levels averaged 12.6, 10.2 and 13.8 nanograms per millilitre, and higher doses did not produce higher peaks [12].
Peaks came after 0.08 hours, roughly five minutes. The half-life could not be calculated, because fewer than three measurable samples remained as levels fell [12].
Tesamorelin, injected under the skin, has a half-life of about 11 minutes in healthy adults. Its peak level comes after a median of 0.15 hours, roughly 9 minutes [5].
Why the numbers cannot be lined up
The two sets of results come from different populations, routes, endpoints and trial lengths. All nine controlled AOD-9604 trials in people used the mouth or a vein [2], [6], [10]. Tesamorelin was injected under the skin in adults with HIV. A per cent of belly fat cannot be set against a missed weight target.
Safety
The two safety records rest on different foundations. Tesamorelin has an official American label drawn from its approval trials. AOD-9604 has a pooled safety report from six sponsor trials with 893 participants, plus three registered pain trials. It has no official label, so no contraindications or interaction warnings are on file [2], [17].
AOD-9604, from the trial reports:
- Headache was the most common event nearly everywhere. After infusion into a vein it affected 16 of 23 volunteers, or 69.6 per cent. Over 24 weeks of tablets it reached 25.9 per cent, with no pattern by group [2].
- Stomach and bowel complaints affected 22.9 per cent in the 24-week trial, and diarrhoea 7.8 per cent [2].
- No antibodies against AOD-9604 were found in the 12-week and 24-week trials. That applies to swallowed doses only and says nothing about repeated injections [2], [18].
- Cancers as adverse events. Five participants in the twelve-week trial developed cancers, three of them skin cancers. The investigator classed none as treatment-related. No independent check of that judgement could be found in the sources reviewed for this page [2].
- The FDA's position. The agency lists AOD-9604 among bulk substances nominated but withdrawn for compounding. It warns of possible immune reactions for certain routes and says it has identified serious adverse events whose cause is not clear [18].
Tesamorelin, from the American label:
- Injection-site reactions in 17 per cent against 6 per cent on placebo over the first 26 weeks, including redness, itching, pain and swelling [5].
- Joint pain in 13 per cent against 11 per cent. Muscle pain affected 6 per cent against 2 per cent. Swelling of the ankles and feet affected 6 per cent against 2 per cent [5].
- Higher odds of diabetes (odds ratio 3.3; 1.4 to 9.6) [5].
- Raised IGF-1. At 26 weeks, 47 per cent of participants were more than two standard deviations above normal. The label calls the long-term consequences unknown [5].
- Antibodies in about half of those treated, 50 per cent at 26 weeks. None of this visibly changed how well the drug worked [5].
- Situations that rule it out entirely: an active cancer, a disrupted link between the hypothalamus and the pituitary gland, a known allergy, and pregnancy [5].
Products sold as research peptides raise a separate problem for both. Reviews from 2026 place this whole group of peptides, tesamorelin included, in the unregulated market for research compounds. There, composition and purity are unverified [6], [19].
Why this page lists no doses. Tesamorelin is a prescription medicine. Choosing an amount is a matter for the official product information and the prescribing doctor. Because the stricter rule applies to the whole comparison, this page reports what the studies measured for both substances without repeating the amounts they used.
Legal status
Since 10 November 2010 tesamorelin has been a US prescription medicine approved only for excess belly fat in adults with HIV and lipodystrophy [20]. Its European application was withdrawn on 21 June 2012, and the Canadian product was cancelled on 30 September 2022 [21], [22]. No approval for AOD-9604 could be found; register searches in Europe, Canada and the United Kingdom came back empty [23], [24], [25]. Australia lists it as prescription-only and makes possession without authority an offence [26]. Both are banned in sport at all times, AOD-9604 under section S2.2.3 and tesamorelin under S2.2.4 of the 2026 list [27]. German anti-doping law names both [28], [29]. Status: 7 and 10 September 2026.
Used together?
The blend directory lists no product that combines AOD-9604 and tesamorelin. AOD-9604 appears there in one mixture, AOD-9604 + CJC-1295 + Ipamorelin, which the directory describes as not studied clinically. Tesamorelin appears in mixtures with growth hormone peptides, such as Tesamorelin + Ipamorelin, which holds no approval. The full list is under blends.
No study of AOD-9604 and tesamorelin given together could be found in the sources reviewed for this page. The effect and safety of the combination are therefore unknown.
More on both substances is in the monographs on AOD-9604 and tesamorelin. The rules of sport for both classes are set out under peptides banned in sport.
Frequently asked questions
Which is better, AOD-9604 or tesamorelin?
Neither can be ranked, because no study comparing them could be found. In 412 adults with HIV and lipodystrophy, deep belly fat fell by 15.2 per cent on tesamorelin over 26 weeks. It rose by 5.0 per cent on placebo. In 502 randomised adults with obesity, AOD-9604 missed its weight target. The people and endpoints differ too much for a verdict.
Which is better for fat loss, AOD-9604 or tesamorelin?
The trials cannot answer that. Tesamorelin is approved only to reduce excess belly fat in adults with HIV and lipodystrophy. Its label states that it is not for weight loss. AOD-9604 was developed for obesity, but its largest trial missed its weight target and the programme was terminated in 2007.
What is the difference between AOD-9604 and tesamorelin?
Tesamorelin is a copy of the brain hormone that tells the pituitary gland to release growth hormone, and it raises IGF-1. AOD-9604 is a small piece cut from growth hormone itself. It releases nothing, and in its 24-week trial IGF-1 did not move. Tesamorelin is a US prescription medicine, while register searches in six markets found no approval for AOD-9604.
Is AOD-9604 or tesamorelin safer?
No study weighing their safety side by side could be found, so no ranking is possible. Tesamorelin has an official label, with injection-site reactions in 17 per cent against 6 per cent on placebo. AOD-9604 has no label, and headache was the most common complaint in its trials. The FDA says it has identified serious adverse events whose cause is not clear.
Can AOD-9604 and tesamorelin be taken together?
No study of the two given together could be found in the sources reviewed for this page. The effect and safety of the combination are therefore unknown. The blend directory lists no product that contains both. It lists AOD-9604 with CJC-1295 and ipamorelin, described as not studied clinically, and tesamorelin with ipamorelin, which holds no approval.
Does AOD-9604 release growth hormone like tesamorelin?
No. Tesamorelin binds to the pituitary gland and prompts it to release the body's own growth hormone. In its first approval trial, IGF-1 rose by 81 per cent. AOD-9604 is a fragment of the hormone that does not switch on the growth hormone receptor. Over 24 weeks, IGF-1 showed no difference between AOD-9604 and placebo (p = 0.75754).
How long do AOD-9604 and tesamorelin last in the body?
Tesamorelin has a half-life of about 11 minutes in healthy adults. For AOD-9604 the half-life could not be calculated in the only published human pharmacokinetic study, because too few blood samples stayed measurable. After infusion into a vein, its peak level came after roughly five minutes.
Are AOD-9604 and tesamorelin approved?
Tesamorelin has been approved in the United States since 10 November 2010 for belly fat in adults with HIV and lipodystrophy. The Canadian product was cancelled in 2022. Its European application was withdrawn in 2012. Register searches for AOD-9604 in six markets found no approval on 10 September 2026. Australia lists it as prescription-only and makes possession without authority an offence.
Are AOD-9604 and tesamorelin banned in sport?
Yes, both at all times, in competition and out of it, but in different sections. The 2026 prohibited list names AOD-9604 in section S2.2.3 among growth hormone fragments, and tesamorelin in section S2.2.4 among the releasing factors. Both count as non-specified substances, and German anti-doping law names both.
Sources
Two original titles below name a brand. They are replaced by a neutral description based on the generic name; this concerns entries 5 and 21. Authors, journal, year, volume, pages, PMID, DOI and web address are unchanged.
- FDA/NCATS Global Substance Registration System, UNII 7UP768IP4M; preferred name LAT-8881, substance class protein, sequence YLRIVQCRSVEGSCGF with a cyclic (7→14) disulfide, CAS 221231-10-3. Retrieved 10 September 2026. https://gsrs.ncats.nih.gov
- Stier H, Vos E, Kenley D (2013). Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. Journal of Endocrinology and Metabolism 3(1-2):7-15. DOI 10.4021/jem157w. Pooled safety report of the six Metabolic Pharmaceuticals trials METAOD001 to METAOD006, 893 participants, 2001 to 2006. All three authors declared financial ties to the sponsor. https://jofem.org/index.php/jofem/article/view/157
- Heffernan MA, Thorburn AW, Fam B, Summers R, Conway-Campbell B, Waters MJ, Ng FM (2001). Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. International Journal of Obesity 25(10):1442-1449. PMID 11673763. DOI 10.1038/sj.ijo.0801740
- Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R (2000). Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Hormone Research 53(6):274-278. PMID 11146367
- Tesamorelin for injection — US Prescribing Information. Theratechnologies Inc., revision 03/2025. DailyMed setid 839334d3-8c1d-4c26-9036-2ab524a6ea75. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
- Dominikowski J et al. (2026). The emerging landscape of performance-enhancing peptides modulating the GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Frontiers in Endocrinology. PMID 42395176. PMC13322892. Section 3.4.2 on AOD9604, including the note that the negative verdict rests on sponsor-reported outcomes, and the documented grey-market regimens.
- Metabolic Pharmaceuticals Limited (2007). Metabolic's obesity drug — phase 2B clinical trial results: trial results do not support commercial viability of obesity project: programme is terminated. ASX announcement, Melbourne. Cited and quoted as reference 85 in source [2]; 534 enrolled, 502 randomised.
- Falutz J, Allas S, Blot K et al. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 357(23):2359-2370. PMID 18057338. DOI 10.1056/NEJMoa072375
- Falutz J, Potvin D, Mamputu JC et al. (2010). Effects of tesamorelin in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. Journal of Acquired Immune Deficiency Syndromes 53(3):311-322. PMID 20101189. DOI 10.1097/QAI.0b013e3181cbdaff
- ClinicalTrials.gov. NCT03865953, a phase 2a study of the efficacy and safety of oral LAT8881 in neuropathic pain; sponsor Lateral Pharma Pty Ltd; n = 53; April 2019 to May 2020; results posted. Retrieved 10 September 2026. https://clinicaltrials.gov/study/NCT03865953
- ClinicalTrials.gov. NCT04153409, a proof-of-concept study of the efficacy and safety of oral LAT8881 in acute migraine; sponsor Lateral Pharma Pty Ltd; n = 21; September 2019 to April 2020; results posted. Retrieved 10 September 2026. https://clinicaltrials.gov/study/NCT04153409
- ClinicalTrials.gov. NCT05298306, a two-part proof-of-concept study assessing the safety and efficacy of LAT8881 in lumbar radicular pain; sponsor Lateral Pharma Pty Ltd; n = 26; May 2022 to June 2023; results posted, including the pharmacokinetic endpoints. Retrieved 10 September 2026. https://clinicaltrials.gov/study/NCT05298306
- Stanley TL, Fourman LT, Feldpausch MN et al. (2019). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV 6(12):e821-e830. PMID 31611038. DOI 10.1016/S2352-3018(19)30338-8
- Baker LD, Barsness SM, Borson S et al. (2012). Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults. Archives of Neurology 69(11):1420-1429. PMID 22869065. DOI 10.1001/archneurol.2012.1970
- Ellis RJ, Vaida F, Hu K et al. (2025). Effects of tesamorelin on neurocognitive impairment in persons with HIV and abdominal obesity. Journal of Infectious Diseases 231(5):1230-1238. PMID 39813152. DOI 10.1093/infdis/jiaf012
- Falutz J, Allas S, Mamputu JC et al. (2008). Long-term safety and effects of tesamorelin in HIV patients with abdominal fat accumulation. AIDS 22(14):1719-1728. PMID 18690162. DOI 10.1097/QAD.0b013e32830a5058
- U.S. Food and Drug Administration. GRAS Notice Inventory, search for "AOD9604"; no records found. Retrieved 10 September 2026. https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices
- U.S. Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks; page updated 22 April 2026; AOD-9604 listed under substances nominated but withdrawn. Retrieved 10 September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- Mendias CL, Awan TM et al. (2026). Safety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance. Sports Medicine 56(8):1921-1935. PMID 41966639. DOI 10.1007/s40279-026-02437-0
- Drugs@FDA / openFDA, application 022505, approval and supplement history. Retrieved 7 September 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22tesamorelin%22
- European Medicines Agency. Withdrawn application for tesamorelin. Withdrawal 21 June 2012, applicant Ferrer Internacional S.A. https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/egrifta
- Health Canada, Drug Product Database, DIN 02438712. Status "Cancelled Post Market" since 30 September 2022. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92311
- European Medicines Agency. Full-text and medicines search for "AOD-9604"; no result. Retrieved 10 September 2026. https://www.ema.europa.eu/en/medicines
- Health Canada. Drug Product Database, active ingredient API query "AOD"; empty result, with a control query for tesamorelin returning entries in the same call. Retrieved 10 September 2026. https://health-products.canada.ca/api/drug/activeingredient/
- MHRA. products.mhra.gov.uk, search for "AOD-9604"; no product entry. Retrieved 10 September 2026.
- Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026, F2026L00633, registered 28 May 2026. Schedule 4 entry "AOD-9604 (CAS No. 221231-10-3)"; Appendix D, clause 5, item 3. https://www.legislation.gov.au/F2026L00633/asmade
- World Anti-Doping Agency. The 2026 Prohibited List, in force from 1 January 2026; section S2.2.3 for growth hormone fragments and section S2.2.4 for releasing factors; official text as annex to BGBl. III No. 219 of 30 December 2025. Retrieved 10 September 2026.
- Annex to the German Anti-Doping Act (AntiDopG), to section 2 subsection 3; BGBl. 2023 I No. 67, pages 1-5, part II.2.3, "Wachstumshormon-Fragmente / Zum Beispiel: AOD-9604 / hGH-Fragment 176-191". gesetze-im-internet.de. Retrieved 10 September 2026.
- Schedule to the German Anti-Doping Act (AntiDopG), section 2.4, growth hormone releasing factors. https://www.gesetze-im-internet.de/antidopg/anlage.html