Asundexian: a systematic review of safety, efficacy, and pharmacological insights in thrombosis.
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Authors
Aldeen, Ziad Sad
Patel, Ravi
Al-Hashemi, Nawaf
Kokori, Emmanuel
Aderinto, Nicholas
Olatunji, Gbolahan
Gaur, Aditya
Moradeyo, Abdulrahmon
Shaka, Hafeez
Issue Date
2025-11-22
Type
Journal Article
Review
Review
Language
en
Keywords
Anticoagulation , Asundexian , Factor XIa inhibitor , Thrombosis
Alternative Title
Abstract
Background: Asundexian, a novel oral Factor XIa (FXIa) inhibitor, targets the intrinsic coagulation pathway to prevent thrombosis while potentially reducing bleeding risk compared to direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs). This systematic review synthesizes clinical evidence on its safety, efficacy, and pharmacological properties in managing arterial and venous thrombotic events.
Methods: Following PRISMA guidelines, we searched PubMed, Embase, Scopus, Cochrane Library, ClinicalTrials.gov, and Web of Science for clinical trials and observational studies on asundexian until January 2025. Inclusion criteria included studies reporting safety, efficacy, and pharmacokinetics/pharmacodynamics (PK/PD) outcomes. Two reviewers independently screened studies and extracted data, with quality assessed using the Cochrane Risk of Bias 2 tool.
Results: Eleven trials (n > 21,000, phases 1-3) were included. Asundexian suppressed FXIa activity, with phase 2 trials (e.g., PACIFIC-AF, PACIFIC-STROKE) showing reduced bleeding compared to apixaban. However, the phase 3 OCEANIC-AF trial was terminated early due to inferior efficacy in atrial fibrillation, with higher stroke/systemic embolism rates (2.5%) versus apixaban. PK/PD data support once-daily dosing with minimal drug interactions. Safety concerns include potential abnormal uterine bleeding, with limited data.
Conclusion: Asundexian shows promise in reducing bleeding but lacks efficacy in high-risk settings like atrial fibrillation. Ongoing trials are needed to define its role in specific thrombotic conditions.
Description
© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creati​​vecommons.org/licenses/by-nc-nd/4.0/
Citation
Aldeen, ZS. et al. (2025) 'Asundexian: a systematic review of safety, efficacy, and pharmacological insights in thrombosis', Thrombosis Journal 23(1) 114. Available At: https://doi.org/10.1186/s12959-025-00807-8
Publisher
Springer Nature
License
© 2025. The Author(s).
Journal
Thrombosis journal
Volume
23
Issue
1
PubMed ID
ISSN
1477-9560