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 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 July 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05686070 (OCEANIC-STROKE) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks 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