Iloperidon Medicine 04 December 2025 Extended indication Treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Negative CHMP opinion Product Active substance Iloperidon Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Schizophrenia, psychosis, bipolar disorder Extended indication Treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Vanda Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date January 2025 Expected Registration Orphan drug No Registration phase Negative CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve CHMP-opinie in februari 2026 Therapeutic value Current treatment options Klassieke (typische) en atypische antipsychotica Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Er bestaan hart gerelateerde veiligheidsrisicoʼs (QT-verlenging en mogelijke cardiotoxiciteit) bij het gebruik van dit middel, op basis waarop een registratieaanvraag in 2017 was geweigerd. Omdat deze risico’s blijven bestaan en de voordelen ten opzichte van bestaande middelen beperkt lijken, is de meerwaarde onzeker. Daarom is het niet waarschijnlijk dat dit middel breed ingezet zal worden. Duration of treatment Frequency of administration Dosage per administration References NCT04819776 (VP-VYV-683-3201); Expertopinie Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Het geneesmiddel zal zijn plaats via substitutie moeten vinden. Clustering verwacht met andere atypische antipsychotica. Aantallen patiënten verwacht: minder dan 500. 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