BHV-7000 Medicine 04 June 2026 Extended indication Treatment of bipolar I disorder in adults and elderly with manic episodes with or without mixed features, monotherapy. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance BHV-7000 Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Schizophrenia, psychosis, bipolar disorder Extended indication Treatment of bipolar I disorder in adults and elderly with manic episodes with or without mixed features, monotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biohaven Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks BHV-7000 is een selectieve Kv7.2/7.3-activator. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De studie voldeed niet aan het primaire eindpunt en is uit de pijplijn van de fabrikant verwijderd. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Maximal 21 day / days Frequency of administration 1 times a day Dosage per administration 75 mg References NCT06419582 Additional remarks Expected patient volume per year Patient volume < 211,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Multidisciplinaire richtlijn bipolaire stoornissen. Trimbos-instituut. 2015. 2: Additional remarks Naar schatting heeft 1,3% van de Nederlanders een bipolaire stoornis. Dat zijn ongeveer 211.000 personen, waaronder vrijwel evenveel mannen en vrouwen (1). 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