Trial reportJournal of thrombosis and haemostasis : JTH2021
First evaluation of the safety, pharmacokinetics, and pharmacodynamics of BAY 2433334, a small molecule targeting coagulation factor XIa.
Trial report in Journal of thrombosis and haemostasis : JTH, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 79 citations in OpenAlex.
- Effect of Age, Sex, Renal Impairment and Hepatic Impairment on the Safety, Pharmacokinetics and Pharmacodynamics of Asundexian.Clinical pharmacokinetics · 2024Trial
- Pharmacokinetics, pharmacodynamics, and safety of asundexian in healthy Chinese and Japanese volunteers, and comparison with Caucasian data.Clinical and translational science · 2024Trial
- Pharmacokinetics, pharmacodynamics, and safety of frunexian in healthy Chinese volunteer adults: A randomized dose-escalation phase I study.Clinical and translational science · 2024Trial
- The Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, an Oral Small Molecule Factor XIa Inhibitor, in Healthy Chinese Volunteers.Clinical drug investigation · 2023Trial
- First randomized evaluation of safety, pharmacodynamics, and pharmacokinetics of BAY 1831865, an antibody targeting coagulation factor XI and factor XIa, in healthy men.Journal of thrombosis and haemostasis : JTH · 2022Trial
- First evaluation of the safety, pharmacokinetics, and pharmacodynamics of BAY 2433334, a small molecule targeting coagulation factor XIa.Journal of thrombosis and haemostasis : JTH · 2021Trial
- FXI and FXII in experimental stroke and FXI in clinical stroke trials.Neurological research and practice · 2026Review
- A comprehensive multicenter study assessing the impact of abelacimab, asundexian, and milvexian on coagulation assays.Blood advances · 2026Article
- Translational Development of Oral FXIa Inhibitors: A Systematic Review of Molecular Design, Pharmacology, and Indication-Specific Clinical Evidence.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Emerging strategies in venous thromboembolism: a narrative review of pharmacological innovations.Thrombosis journal · 2026Review
- Developing Safer Anticoagulant Candidates: Structure-Activity Relationship Studies of 5-Amino-Triazole-Based FXIIa Inhibitors.Medicinal chemistry (Shariqah (United Arab Emirates)) · 2026Article
- An Overview of Anticoagulant Drugs Pharmacology, Therapeutic Approaches, Limitations and Perspectives.Pharmaceutics · 2026Review
- Asundexian: a systematic review of safety, efficacy, and pharmacological insights in thrombosis.Thrombosis journal · 2025Review
- Population Pharmacokinetics of Asundexian in People at Risk for Thromboembolic/Cardiovascular Events.CPT: pharmacometrics & systems pharmacology · 2025Article
- Factor XI inhibitors for the prevention and treatment of venous and arterial thromboembolism.Nature reviews. Cardiology · 2025Review
- Structure-based design and synthesis of novel FXIa inhibitors targeting the S2' subsite for enhanced antithrombotic efficacy.Molecular diversity · 2025Article
- The Discovery of a Novel Anticoagulant Mechanism: Factor XI Activation Inhibitors.ACS pharmacology & translational science · 2025Article
- Impact of asundexian on a panel of coagulation assays.Research and practice in thrombosis and haemostasis · 2025Article
- Inhibition of Factor XI Using RBD4059: A Novel GalNAc-siRNA With Potent and Durable Antithrombotic Effects.JACC. Basic to translational science · 2025Article
- Factor XI Inhibition for Atrial Fibrillation: Where Do We Stand?Circulation · 2025Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCoagulation factor XI (FXI) contributes to the development of thrombosis but appears to play a minor role in hemostasis and is, therefore, an attractive anticoagulant drug target.
objectivesTo evaluate the safety, pharmacokinetic, and pharmacodynamic properties of BAY 2433334, an orally administered small molecule targeting activated FXI (FXIa), in healthy men. PATIENTS/
methodsThis phase 1 study was conducted in two parts. In part 1, 70 volunteers were randomized 4:1 to receive a single oral dose of BAY 2433334 (5-150 mg as oral solution or immediate-release tablets) or placebo. In part 2, 16 volunteers received a single oral dose of five BAY 2433334 5-mg tablets with or without a high-calorie breakfast in a randomized crossover study design. Adverse events, pharmacokinetic parameters, and pharmacodynamic parameters were assessed up to 72 h after drug administration. Volunteers were followed up after 7 to 14 days.
resultsBAY 2433334 demonstrated favorable safety and tolerability with a dose-dependent increase in exposure and a terminal half-life of 14.2 to 17.4 h. A high-calorie breakfast reduced mean maximum plasma concentration and exposure by 31% and 12.4%, respectively. AY 2433334 was associated with a dose-dependent inhibition of FXIa activity and an increase in activated partial thromboplastin time. Bleeding times in volunteers who had received BAY 2433334 were similar to those in volunteers who had received placebo.
conclusionsThese data indicate that BAY 2433334 is a promising development candidate for once-daily oral anticoagulation; it is being evaluated in phase 2 dose-finding studies in patients at risk of thrombosis.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.