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Ulotaront

Extended indication Schizofrenie
Therapeutic value No estimate possible yet
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
Manufacturer Otsuka
Portfolio holder Otsuka
Mechanism of action Receptor agonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Serotonin 1A receptor agonists; Trace amine-associated receptor 1 agonists

Registration

Registration route Centralised (EMA)
ATMP No
Submission date 2024
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Mogelijk is dit een interessante nieuwe ontwikkeling. Er is echter nog te weinig informatie om een inschatting te maken.
Frequency of administration 1 times a day
Dosage per administration 50 mg / 75 mg / 100 mg
References NCT04109950, NCT04072354, NCT04092686, NCT04115319, NCT04825860

Expected patient volume per year

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

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions fase 3: Generalised anxiety disorder; Major depressive disorder.
References Adis Insight

Other information

There is currently no futher information available.