Milvexian for the Prevention of Venous Thromboembolism.

  title={Milvexian for the Prevention of Venous Thromboembolism.},
  author={Jeffrey I. Weitz and John Strony and Walter Ageno and David Gailani and Elaine Hylek and Michael Rud Lassen and Kenneth W. Mahaffey and Ravi S Notani and Robin S Roberts and Annelise Segers and Gary E. Raskob},
  journal={The New England journal of medicine},
BACKGROUND Factor XIa inhibitors for the prevention and treatment of venous and arterial thromboembolism may be more effective and result in less bleeding than conventional anticoagulants. Additional data are needed regarding the efficacy and safety of milvexian, an oral factor XIa inhibitor. METHODS In this parallel-group, phase 2 trial, we randomly assigned 1242 patients undergoing knee arthroplasty to receive one of seven postoperative regimens of milvexian (25 mg, 50 mg, 100 mg, or 200 mg… 
Factor XI as a target for preventing venous thromboembolism
  • D. Gailani
  • Medicine, Biology
    Journal of thrombosis and haemostasis : JTH
  • 2022
Cumulatively, this work provides strong evidence that FXI contributes to DVT in patients undergoing TKA, and justifies further investigation of FXI and FXIa as antithrombotic targets.
Factor XI Inhibition for the Prevention of Venous Thromboembolism: An Update on Current Evidence and Future perspectives
A narrative review of the key data published to date with compounds targeting factor XI to prevent thrombosis as well as the main ongoing clinical studies is proposed, opening up prospects for improving the care of patients requiring thromBosis prevention.
Factor XI Inhibitors for Prevention and Treatment of Venous Thromboembolism: A Review on the Rationale and Update on Current Evidence
Unmet clinical needs of anticoagulation therapy are highlighted, the rationale and evidence for inhibiting FXI is outlay, and several promising approaches to reduce the bleeding risk involve targeting the intrinsic pathway of coagulation, with the ultimate goal of preventing thrombosis without impairing hemostasis.
Safety, pharmacokinetics, and pharmacodynamics of milvexian in healthy Japanese participants
The pharmacokinetic and pharmacodynamic profile of milvexian demonstrates suitability for further clinical development in Japanese participants and shows safety, tolerability, pharmacokinetics, and pharmacodynamics well tolerated.
Single-Dose Pharmacokinetics of Milvexian in Participants with Mild or Moderate Hepatic Impairment Compared with Healthy Participants
Observed pharmacokinetic changes suggest it is unlikely that dose adjustments will be necessary in patients with mild or moderate hepatic impairment, and milvexian was well tolerated in participants with normal, mildly impaired, and moderately impaired hepatic function.
Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment
A single dose of milvexian 60 mg was safe and well tolerated in participants with normal renal function and moderate or severe renal impairment, and there was a similar increase in milveXian exposure between the moderate and severe renal groups.
Direct Oral Anticoagulants and Coronary Artery Disease
The clinical data regarding the use of direct oral anticoagulants in different patient populations with coronary disease and the balance between protection against ischemia and bleeding are summarized.
A Factor XIa Inhibitor Engineered from Banded Krait Venom Toxin: Efficacy and Safety in Rodent Models of Arterial and Venous Thrombosis
RFasxiatorN17R,L19E represents a promising molecule for the development of FXIa-targeting anticoagulants and bleeding risk assessment in pre-clinical animal models.