Asundexian Medicine 04 December 2025 Extended indication Asundexian monotherapy for preventive treatment of ischaemic stroke in adults and elderly without atrial fibrillation following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Asundexian Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Antithrombotic medications Extended indication Asundexian monotherapy for preventive treatment of ischaemic stroke in adults and elderly without atrial fibrillation following a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Bayer Portfolio holder Bayer Mechanism of action Anticoagulant Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date May 2026 Expected Registration February 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Bij herseninfarcten in Nederland is de meerderheid van de infarcten niet bij patiënten met AF en non-cardio-embolisch. De inzet van dit middel gaat dus om een groot indicatiegebied. De positionering van dit middel in richtlijnen is nog onbekend. Duration of treatment Frequency of administration Dosage per administration References NCT05686070 (OCEANIC-STROKE); Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.vzinfo.nl/beroerte/leeftijd-en-geslacht/naar-type Additional remarks In Nederland krijgen jaarlijks 30.000 tot 40.000 mensen een ischemische beroerte, waarvan een deel zonder atriumfibrillatie en met een non-cardio-embolische oorzaak mogelijk in aanmerking komt voor asundexian‑monotherapie. Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks