Oveporexton Medicine 04 June 2026 Extended indication Narcolepsy with cataplexy (Narcolepsy Type 1) Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Oveporexton Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Sleep disorders Extended indication Narcolepsy with cataplexy (Narcolepsy Type 1) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Takeda Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise SEIN Expertisecentrum voor epilepsie en slaapgeneeskunde Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijnen op basis van ISHI inschatting. Therapeutic value Current treatment options pitolisant, solriamfetol, sodium oxybate (Hydroxyboterzuur) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog weinig onderzoek gedaan, maar het lijkt effectief. Hoe de effectiviteit en bijwerkingen zich verhouden tot de huidige behandelopties is nog niet bekend. Duration of treatment Frequency of administration Dosage per administration References NCT06470828 (FirstLight); NCT06505031(RadiantLight); Expertopinie Additional remarks Expected patient volume per year Patient volume 550 - 1,100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Narcolepsie.nl (1); GIPdatabank.nl (N07XX11: Pitolisant. N06BA14: Solriamfetol. N07XX04: Hydroxyboterzuur) (2). Additional remarks In Nederland hebben naar schatting tussen de 6.000 en 8.000 mensen symptomen van narcolepsie, terwijl bij ongeveer 1.500 patiënten de diagnose is gesteld (1). Op basis van declaratiedata ligt het volume van gebruikers van middelen voor narcolepsie tussen de 550 en 1.100 (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