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AOD-9604 and Clopidogrel Interaction: What Patients and Clinicians Need to Know

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At a glance

  • AOD-9604 status / Not FDA-approved; a 16-amino-acid fragment of human growth hormone [2][4]
  • Clopidogrel / Antiplatelet prodrug bioactivated by CYP2C19 [1]
  • AOD-9604 dose / No approved dose [3]
  • FDA safety note / Serious adverse events possibly associated, causality not clear [5]

How clopidogrel depends on CYP2C19

Clopidogrel does nothing until the liver converts it. CYP2C19 catalyzes that bioactivation; intermediate and poor metabolizers form less active metabolite, get reduced platelet inhibition, and carry a higher risk of major cardiovascular and cerebrovascular events [1]. Clopidogrel's activation through CYP2C19 is one possible interaction pathway, but the available evidence does not show whether AOD-9604 affects that enzyme or platelet function [1].

What is known about AOD-9604

AOD-9604 is a modified fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, 16 amino acids in total. It is not full-length growth hormone [4]. It was developed as an anti-obesity drug candidate, and phase IIa trials were underway by February 2002 [2]. It never reached approval. A 2026 review describes a sponsor-reported 24-week oral obesity trial that failed its primary weight-loss endpoint, and the obesity program was later dropped [3].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in its nominated-but-withdrawn table. It cites possible immunogenicity from peptide impurities, no or only limited safety information, and serious adverse events that may be associated with it, though causality is not clear [5].

What remains unknown

No published human data on whether AOD-9604 inhibits or induces CYP2C19 or any other CYP enzyme have been identified. The same is true of data on its effect on platelet aggregation or bleeding. That gap is the answer to the interaction question, not a reassurance.

Bottom line

Clopidogrel's antiplatelet effect depends on CYP2C19 activation, and genotype alone produces measurable differences in platelet inhibition [1]. AOD-9604 is an unapproved peptide with no approved dose and limited, largely short-term human evidence [3].

Frequently asked questions

What is AOD-9604?
It is a modified fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, 16 amino acids in total, which is why it is also called hGH fragment 176-191. It is not full-length growth hormone [4].
Is AOD-9604 FDA-approved?
No. It was developed as an anti-obesity candidate, phase IIa trials were underway by February 2002, and it never reached approval [2][3]. FDA lists it in the nominated-but-withdrawn table for bulk substances that may present significant safety risks [5].
Does AOD-9604 have an approved dose?
No. The human obesity trial described in a 2026 review tested an oral drug candidate, and that review concludes human evidence for AOD-9604 is limited and largely short-term [3].
Why does CYP2C19 genotype matter for clopidogrel?
Intermediate and poor metabolizers form less active metabolite and get reduced platelet inhibition, with higher risk of major cardiovascular and cerebrovascular events [1]. In TAILOR-PCI (5,302 patients after PCI), genotype-guided ticagrelor in loss-of-function carriers gave a 12-month primary endpoint rate of 4.0% versus 5.9% on clopidogrel (HR 0.66, 95% CI 0.43-1.02), not statistically significant [7].

References

  1. Lee CR, Luzum JA, Sangkuhl K, Gammal RS, Sabatine MS, Stein CM, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update. Clin Pharmacol Ther. 2022;112(5):959-967. Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update
  2. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  3. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, RuchaŁa M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration
  4. Cox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-8. Detection and in vitro metabolism of AOD9604
  5. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  6. Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010;363(20):1909-17. Clopidogrel with or without omeprazole in coronary artery disease
  7. Pereira NL, Farkouh ME, So D, Lennon R, Geller N, Mathew V, et al. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial. JAMA. 2020;324(8):761-771. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial
Evidence overview for AOD-9604 and Clopidogrel Interaction: What Patients and Clinicians Need to Know