Ulixacaltamide Medicine 03 June 2025 Extended indication Ulixacaltamide monotherapy for treatment of Essential tremor in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ulixacaltamide Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other Extended indication Ulixacaltamide monotherapy for treatment of Essential tremor in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Praxis Precision Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Propranolol Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn fase 2 trials geweest met positieve resultaten. De fase 3 trial loopt. Duration of treatment Frequency of administration 1 times a day Dosage per administration 60 mg References NCT06087276; Expertopinie Additional remarks Expected patient volume per year Patient volume < 5,700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Standpunt High intensity focused ultrasound bij volwassen patiënten met essentiële tremor. Zorginstituut. 2023 (1). Additional remarks De prevalentie in de algehele bevolking ligt rond de 0,5 tot 1%. De prevalentie van essentiële tremor neemt sterk toe met de leeftijd. Bij volwassenen ouder dan 60 jaar bedraagt dit ongeveer 5%. De huidige prevalentie van patiënten met matige tot ernstige essentiële tremor is circa 5.700 (1). 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 Indication extensions References Additional remarks Other information Additional remarks