CASE REPORT article
Front. Med.
Sec. Precision Medicine
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1634101
Analysis of Alarelin acetate hepatotoxicity from pharmacogenomic analysis: A case report and literature review
Provisionally accepted
- The Third Hospital of Changsha, Changsha, China
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Background: Alarelin acetate, a synthetic gonadotropin-releasing hormone (GnRH) analogue, is widely used to manage endometriosis and hormone-sensitive malignancies. Although its safety profile is generally favorable, we report the first documented case of severe hepatotoxicity associated with Alarelin acetate administration. Case summary: A 37-year-old female participant in a phase I clinical trial developed acute hepatocellular injury following subcutaneous administration of Alarelin acetate (150 μg/day). RUCAM causality assessment yielded a score of 6, indicating a "highly probable" causal relationship between the drug and liver injury. Hepatic enzymes levels normalized within 18 days after drug discontinuation and initiation of hepatoprotective therapy (glycyrrhizin, polyene phosphatidylcholine). Pharmacogenomic profiling identified specific genetic variations that may be associated with alarelin acetate hepatotoxicity, including a homozygous NUDT15 variant (*3/*3 diplotype) and Human leukocyte antigen (HLA) risk alleles (HLA-DRB1*15:01, HLA-DQB1*06:01). Conclusion: This novel case highlights the risk of Alarelin acetate-related hepatotoxicity. Pharmacogenomic profiling indicates its hepatotoxicity may be related to gene polymorphisms, but further research or larger-scale studies are needed to validate these associations.
Keywords: Alarelin Acetate, Drug-induced liver injury (DILI), pharmacogenomics, human leukocyte antigen (HLA), single nucleotide polymorphism (SNP)
Received: 23 May 2025; Accepted: 02 Sep 2025.
Copyright: © 2025 Yuan, Zhang, Liu, Li, Xu and Xin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Li Xin, The Third Hospital of Changsha, Changsha, China
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