Osilodrostat Medicine 04 June 2026 Extended indication Treatment of endogenous Cushing’s syndrome in adolescents and children aged 6 years and older. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Osilodrostat Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Treatment of endogenous Cushing’s syndrome in adolescents and children aged 6 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Isturisa Manufacturer Recordati Portfolio holder Recordati Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: cortisol synthese remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP No Submission date December 2025 Expected Registration July 2026 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03708900 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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