Skip to main content
Top

Open Access 17-08-2024 | Acute Coronary Syndrome | Review

Milvexian: An Oral, Bioavailable Factor XIa Inhibitor

Authors: Shyon Parsa, Sneha S. Jain, Olu Akinrimisi, Carolyn S. P. Lam, Kenneth W. Mahaffey

Published in: Cardiology and Therapy

Login to get access

Abstract

Direct oral anticoagulants have a dose-dependent increased bleeding risk which limits use in certain populations. Studies in both animals and humans with inherited variations in factor XI levels provide a theoretical basis for a drug target capable of addressing current unmet needs. Milvexian is an oral factor XIa inhibitor that has the potential to provide robust anticoagulant effect without increased bleeding compared with current standard of care. Several key studies in the preclinical, phase I, and phase II stages have reported promising safety data in venous thromboembolism and stroke prevention without compromising hemostasis. The planned phase III trials will examine the efficacy of milvexian for prevention of thrombotic events in patients with acute stroke, acute coronary syndrome, and atrial fibrillation.
Literature
13.
go back to reference Periayah MH, Halim AS, Mat Saad AZ. Mechanism action of platelets and crucial blood coagulation pathways in hemostasis. Int J Hematol Oncol Stem Cell Res. 2017;11(4):319–27.PubMedPubMedCentral Periayah MH, Halim AS, Mat Saad AZ. Mechanism action of platelets and crucial blood coagulation pathways in hemostasis. Int J Hematol Oncol Stem Cell Res. 2017;11(4):319–27.PubMedPubMedCentral
25.
go back to reference Rosen ED, Gailani D, Castellino FJ. FXI is essential for thrombus formation following FeCl3-induced injury of the carotid artery in the mouse. Thrombosis Haemostasis. 2002;87(4):774–6.CrossRefPubMed Rosen ED, Gailani D, Castellino FJ. FXI is essential for thrombus formation following FeCl3-induced injury of the carotid artery in the mouse. Thrombosis Haemostasis. 2002;87(4):774–6.CrossRefPubMed
30.
go back to reference Janssen Research & Development, LLC. An Open-Label, Randomized, Crossover Study to Evaluate the Relative Oral Bioavailability, Pharmacokinetics, and Food Effect After Single Dose (for Part 1, Part 3, Part 4 and Part 5) or Multiple-Dose (for Part 2) Administration of JNJ-70033093 (Milvexian) in Healthy Adult Participants Using Tablet, Capsule and Dispersed Tablet Formulations. clinicaltrials.gov; 2022. Accessed September 1, 2023. https://clinicaltrials.gov/study/NCT04844424. Accessed 1 Sep 2023. Janssen Research & Development, LLC. An Open-Label, Randomized, Crossover Study to Evaluate the Relative Oral Bioavailability, Pharmacokinetics, and Food Effect After Single Dose (for Part 1, Part 3, Part 4 and Part 5) or Multiple-Dose (for Part 2) Administration of JNJ-70033093 (Milvexian) in Healthy Adult Participants Using Tablet, Capsule and Dispersed Tablet Formulations. clinicaltrials.gov; 2022. Accessed September 1, 2023. https://​clinicaltrials.​gov/​study/​NCT04844424. Accessed 1 Sep 2023.
40.
go back to reference Janssen Research & Development, LLC. A phase 3, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of Milvexian, an oral factor XIa inhibitor, for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack. clinicaltrials.gov; 2023. Accessed September 1, 2023. https://clinicaltrials.gov/study/NCT05702034. Accessed 1 Sep 2023. Janssen Research & Development, LLC. A phase 3, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of Milvexian, an oral factor XIa inhibitor, for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack. clinicaltrials.gov; 2023. Accessed September 1, 2023. https://​clinicaltrials.​gov/​study/​NCT05702034. Accessed 1 Sep 2023.
41.
go back to reference Janssen Research & Development, LLC. A phase 3, randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian, an oral factor XIa inhibitor, after a recent acute coronary syndrome. clinicaltrials.gov; 2023. Accessed September 1, 2023. https://clinicaltrials.gov/study/NCT05754957. Accessed 1 Sep 2023. Janssen Research & Development, LLC. A phase 3, randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian, an oral factor XIa inhibitor, after a recent acute coronary syndrome. clinicaltrials.gov; 2023. Accessed September 1, 2023. https://​clinicaltrials.​gov/​study/​NCT05754957. Accessed 1 Sep 2023.
42.
go back to reference Janssen Research & Development, LLC. A phase 3, randomized, double-blind, double-dummy, parallel group, active-controlled study to evaluate the efficacy and safety of milvexian, an oral factor XIa inhibitor, versus apixaban in participants with atrial fibrillation. clinicaltrials.gov; 2023. https://clinicaltrials.gov/study/NCT05757869. Accessed 1 Sep 2023. Janssen Research & Development, LLC. A phase 3, randomized, double-blind, double-dummy, parallel group, active-controlled study to evaluate the efficacy and safety of milvexian, an oral factor XIa inhibitor, versus apixaban in participants with atrial fibrillation. clinicaltrials.gov; 2023. https://​clinicaltrials.​gov/​study/​NCT05757869. Accessed 1 Sep 2023.
44.
go back to reference Piccini JP, Caso V, Connolly SJ, et al. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. The Lancet. 2022;399(10333):1383–90. https://doi.org/10.1016/S0140-6736(22)00456-1.CrossRef Piccini JP, Caso V, Connolly SJ, et al. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. The Lancet. 2022;399(10333):1383–90. https://​doi.​org/​10.​1016/​S0140-6736(22)00456-1.CrossRef
Metadata
Title
Milvexian: An Oral, Bioavailable Factor XIa Inhibitor
Authors
Shyon Parsa
Sneha S. Jain
Olu Akinrimisi
Carolyn S. P. Lam
Kenneth W. Mahaffey
Publication date
17-08-2024
Publisher
Springer Healthcare
Published in
Cardiology and Therapy
Print ISSN: 2193-8261
Electronic ISSN: 2193-6544
DOI
https://doi.org/10.1007/s40119-024-00379-0

A quick guide to ECGs

Improve your ECG interpretation skills with this comprehensive, rapid, interactive course. Expert advice provides detailed feedback as you work through 50 ECGs covering the most common cardiac presentations to ensure your practice stays up to date. 

PD Dr. Carsten W. Israel
Developed by: Springer Medizin
Start the cases

Keynote webinar | Spotlight on medication adherence

  • Webinar | 27-06-2024 | 18:00 (CEST)

Medication non-adherence is a major barrier to effective healthcare delivery; half of all patients do not follow their doctor’s recommendations or treatment plan.

Our experts explain the fundamentals with a practical discussion of how to manage non-adherence in two common scenarios: hypertension and asthma control.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Watch now