Masupirdine Medicine 04 June 2026 Extended indication Masupirdine monotherapy for add-on treatment of agitation associated with Dementia Alzheimerʼs type in adults over 50 years of age and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Masupirdine Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Dementia Extended indication Masupirdine monotherapy for add-on treatment of agitation associated with Dementia Alzheimerʼs type in adults over 50 years of age and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Suven Portfolio holder Suven Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Masupirdine is an orally available, brain-penetrant, selective antagonist of the 5-HT6 serotonin receptor. This G protein-coupled receptor is expressed mostly in the brain, where it mediates neurotransmission for functions including cognition and memory. Blocking this receptor increases cholinergic and glutamatergic signaling. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten uit de fase 3 studie dienen nog afgewacht te worden om een uitspraak te doen over de effectiviteit. Als er effectiviteit wordt gevonden wordt er wel een plek voor geneesmiddelen met dit soort werkingsmechanisme verwacht. Duration of treatment Frequency of administration 1 times a day Dosage per administration 50 mg of 100 mg References NCT05397639 Additional remarks Expected patient volume per year Patient volume < 21,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References http://www.levenmetalzheimer.nl/content/alzheimer/feiten-cijfers.asp, https://www.sfk.nl/publicaties/PW/2016/inzet-medicijnen-bij-dementie-loopt-terug Additional remarks In Nederland zijn 270.000 mensen dement. Hiervan hebben 160.000 tot 190.000 mensen de ziekte van Alzheimer (maximaal 70%). In totaal waren er 30.000 geneesmiddelen gebruikers, die medicijnen kregen tegen dementie (SFK), uitgaande van 70% zal het maximaal gaan om 21.000 patiënten. Indien het geneesmiddel effectief blijkt wordt er verwacht dat ongeveer 5% van de AD patiënten in aanmerking zal komen (2). 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 Indication extensions References Additional remarks Other information Additional remarks