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Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Rationale for the milvexian dosing in the phase 3 LIBREXIA program.

Jeffrey I Weitz1, Robert A Harrington2,

  • 1Departments of Medicine and Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Ontario, Canada; Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada; Hamilton Health Sciences, Hamilton, Ontario, Canada.

Journal of Thrombosis and Haemostasis : JTH
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PubMed
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Milvexian, a novel factor XIa inhibitor, is being tested in Phase 3 trials. Dosing for atrial fibrillation, acute coronary syndrome, and stroke trials was informed by Phase 2 results, aiming for safer anticoagulation.

Keywords:
acute coronary syndromeatrial fibrillationfactor XImilvexianstroke

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Area of Science:

  • Cardiovascular medicine
  • Pharmacology
  • Clinical trials

Background:

  • Milvexian is an oral, small-molecule inhibitor targeting factor XIa (FXIa).
  • FXIa is being investigated as a potentially safer anticoagulant target compared to FXa.
  • Milvexian is currently in Phase 3 clinical development.

Purpose of the Study:

  • To outline the scientific rationale for targeting FXIa over FXa.
  • To detail the pharmacology of milvexian.
  • To review Phase 2 trial outcomes and inform Phase 3 dosing strategies.

Main Methods:

  • This narrative review synthesizes data on milvexian's development.
  • Focuses on the selection process for Phase 3 dosing regimens within the LIBREXIA program.
  • The LIBREXIA program includes trials in atrial fibrillation (AF), acute coronary syndrome (ACS), and stroke.

Main Results:

  • Phase 2 results guided the selection of milvexian's Phase 3 dosage.
  • Specific doses were chosen for different indications: 100 mg BID for AF, 25 mg BID for ACS and stroke.
  • These regimens will be evaluated in approximately 50,000 patients across the LIBREXIA trials.

Conclusions:

  • The selected milvexian doses aim to provide safe and effective anticoagulation.
  • Phase 3 trials (LIBREXIA AF, ACS, Stroke) will validate these regimens.
  • Milvexian represents a promising new oral anticoagulant targeting FXIa.