Ulotaront Medicine 06 June 2023 Extended indication Schizofrenie Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ulotaront Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Schizophrenia, psychosis, bipolar disorder Extended indication Schizofrenie Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Otsuka Portfolio holder Otsuka Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Serotonin 1A receptor agonists; Trace amine-associated receptor 1 agonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2024 Expected Registration 2024 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 Mogelijk is dit een interessante nieuwe ontwikkeling. Er is echter nog te weinig informatie om een inschatting te maken. Duration of treatment Frequency of administration 1 times a day Dosage per administration 50 mg / 75 mg / 100 mg References NCT04109950, NCT04072354, NCT04092686, NCT04115319, NCT04825860 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References De Nederlandse Multidisciplinaire richtlijn Schizofrenie Additional remarks De Nederlandse Multidisciplinaire richtlijn Schizofrenie gaat uit van 1 op de 125 mensen, oftewel 0,8% 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions fase 3: Generalised anxiety disorder; Major depressive disorder. References Adis Insight Additional remarks Other information Additional remarks