Extended indication Adult Patients With Negative Symptoms of Schizophrenia
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Roluperidon
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Schizophrenia, psychosis, bipolar disorder
Extended indication Adult Patients With Negative Symptoms of Schizophrenia
Manufacturer Minerva
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials
Additional comments Indiening bij de FDA verwacht in het derde kwartaal van 2022.

Therapeutic value

Current treatment options Risperidon
Therapeutic value No estimate possible yet
Substantiation Het is nog te vroeg om iets over de mogelijke meerwaarde te zeggen. Ook is het de vraag of dit geneesmiddel echt iets nieuws brengt ten opzichte van risperidon.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 32-64 mg
References NCT03397134

Expected patient volume per year

References Expertopinie(1);
Additional comments Er wordt indien dit geneesmiddel registratie zal halen een klein pati√ęntvolume verwacht.

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 No
References Adis insight
Additional comments Nieuwe indicaties bevinden zich nog in de preklinische fases.

Other information

There is currently no futher information available.