Evidence map›Paper›PMID 41222225›Full record

ArticleCPT: pharmacometrics & systems pharmacology2025

Population Pharmacokinetics of Asundexian in People at Risk for Thromboembolic/Cardiovascular Events.

Ashraf Yassen, Friederike Kanefendt, Jochen Zisowsky, Astrid Broeker, Hardi Mundl, Peter Vis, Dirk Garmann, Jan Berkhout

Registry-linked trialAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05686070 (A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT05686070 phase3completednot on this map

A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA

TypeinterventionalSponsorBayerRan2023 to 2025Enrolled12,327ConditionsPrevention of Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, High-risk Transient Ischemic AttackArmsAsundexian (BAY2433334), Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ashraf YassenBayer AG, Model-Informed Drug Development, Wuppertal, Germany.
Friederike KanefendtBayer AG, Clinical Pharmacology, Wuppertal, Germany.ORCID https://orcid.org/0009-0006-1346-9336
Jochen ZisowskyBayer AG, Pharmacometrics, Berlin, Germany.
Astrid BroekerBayer AG, Pharmacometrics, Wuppertal, Germany.
Hardi MundlBayer AG, Research & Development, Wuppertal, Germany.
Peter VisLAP&P Consultants BV, Leiden, the Netherlands.ORCID https://orcid.org/0000-0001-8726-2692
Dirk GarmannBayer AG, Pharmacometrics, Wuppertal, Germany.ORCID https://orcid.org/0009-0003-5926-3980
Jan BerkhoutLAP&P Consultants BV, Leiden, the Netherlands.ORCID https://orcid.org/0009-0003-2448-7829

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Asundexian is a potent, selective, and reversible inhibitor of activated clotting Factor XI currently under development for secondary prevention of recurrent ischemic stroke in the ongoing Phase III OCEANIC-STROKE study (NCT05686070). Here, we report the development of a population pharmacokinetic (popPK) model for asundexian. Plasma concentration data were available from 2914 participants enrolled in nine Phase I and II studies of asundexian. The pharmacokinetics (PK) of asundexian were well described by the popPK model. Within the investigated dose range of asundexian 10-100 mg once daily, the PK of asundexian was dose-proportional. The systemic apparent clearance (CL/F) of asundexian was estimated to be 2.25 L/h and the central volume of distribution (V

Indexed as

cardiovascular diseaseclinical trialscovariatesphase Iphase IIpopulation pharmacokinetics

Identifiers

PMID41222225
PMCPMC12823300

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Registered trials

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.