Soclenicant Medicine 04 December 2025 Extended indication Soclenicant monotherapy for acute treatment of social anxiety disorder in adults and older adults. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Soclenicant Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Other psychiatry Extended indication Soclenicant monotherapy for acute treatment of social anxiety disorder in adults and older adults. Current proprietary name Already available biosimilars / generics Proprietary name BNC210 Manufacturer Neurophoria Portfolio holder Neurophoria Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Selectieve allosterische modulator. Fabrikant: Neuphoria Therapeutics Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date Expected Registration Orphan drug Registration phase No registration expected Reimbursement Medicine sluice Additional remarks AFFIRM-1 heeft primaire eindpunten niet gehaald. Therapeutic value Current treatment options Psychotherapie is de eerste behandeloptie. Beperkt deel van de patiënten wordt behandeld met medicatie (bijvoorbeeld SSRI's). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten uit de studie dienen afgewacht te worden. Duration of treatment Frequency of administration Dosage per administration References NCT06510504 (AFFIRM-1) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Trimbos. Sociale fobie. 2025. Additional remarks Volgens het Trimbos Instituut heeft 13,1% van de bevolking ooit last gehad van sociale fobie. Het gedeelte van deze patiënten dat hiervoor medicatie krijgt komt mogelijk in aanmerking. 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