Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health

Margret I. Moré, David Kenley


Background: AOD9604 is the C-terminal fragment (Tyr-hGH177-191) of human growth hormone (hGH). Early stage studies with AOD9604 have shown positive activities on fat metabolism. As a result the use of AOD9604 to improve metabolic profiles may be plausible. For these uses, the safety of AOD9604 needs to be clearly demonstrated. Here we report the findings from studies involving the genotoxicological, toxicological and pharmacokinetic testing of AOD9604.

Methods: In an Ames test, the mutagenic potential of AOD9604 was assessed. A chromosomal aberration assay in CHO cells was used to test the mutagenic activity of AOD9604 by its ability to cause structural damage to chromosomes. A bone micronucleus assay incorporated in a 4-week rat intravenous (IV) toxicity study was used to test potential micronucleus formation. In chronic toxicology studies in rats (6 months) and cynomolgus monkeys (9 months), the potential toxicity of AOD9604 was assessed after daily oral gavage. Pharmacokinetic properties of AOD9604 were examined in a study with pigs after oral and IV administration, and rat whole-body radiography after IV and oral 14C-AOD9604 application.

Results: AOD9604 was found to be generally safe after chronic oral application in rats and cynomolgus monkeys. There was no evidence of any genotoxic activities of AOD9604, as examined in an Ames test, a chromosomal aberration assay, or a bone micronucleus assay. Rat whole-body radiography revealed similar organ distribution after IV or oral application. Orally administered AOD9604 in pigs was well absorbed and results revealed rapid degradation kinetics.

Conclusion: Multiple non-clinical studies revealed no evidence of genotoxicological or toxicological concerns regarding the safety of AOD9604.

J Endocrinol Metab. 2014;4(3):64-77


AOD9604; hGH; C-terminus of human growth hormone; Non-clinical studies; Pharmacokinetics; Toxicology; Metabolism; Obesity

Full Text: HTML PDF

Browse  Journals  


Journal of Clinical Medicine Research

Journal of Endocrinology and Metabolism

Journal of Clinical Gynecology and Obstetrics


World Journal of Oncology

Gastroenterology Research

Journal of Hematology


Journal of Medical Cases

Journal of Current Surgery

Clinical Infection and Immunity


Cardiology Research

World Journal of Nephrology and Urology

Cellular and Molecular Medicine Research


Journal of Neurology Research

International Journal of Clinical Pediatrics



Journal of Endocrinology and Metabolism, bimonthly, ISSN 1923-2861 (print), 1923-287X (online), published by Elmer Press Inc.                     
The content of this site is intended for health care professionals.
This is an open-access journal distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits unrestricted
non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Creative Commons Attribution license (Attribution-NonCommercial 4.0 International CC-BY-NC 4.0)

This journal follows the International Committee of Medical Journal Editors (ICMJE) recommendations for manuscripts submitted to biomedical journals,
the Committee on Publication Ethics (COPE) guidelines, and the Principles of Transparency and Best Practice in Scholarly Publishing.

website:   editorial contact:
Address: 9225 Leslie Street, Suite 201, Richmond Hill, Ontario, L4B 3H6, Canada

© Elmer Press Inc. All Rights Reserved.

Disclaimer: The views and opinions expressed in the published articles are those of the authors and do not necessarily reflect the views or opinions of the editors and Elmer Press Inc. This website is provided for medical research and informational purposes only and does not constitute any medical advice or professional services. The information provided in this journal should not be used for diagnosis and treatment, those seeking medical advice should always consult with a licensed physician.