Insulin icodec / semaglutide Medicine 04 June 2026 Extended indication Extension of indication to include treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Insulin icodec / semaglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Diabetes Extended indication Extension of indication to include treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. Current proprietary name Already available biosimilars / generics Proprietary name Kyinsu Manufacturer Novo Nordisk Portfolio holder Novo Nordisk Mechanism of action Insulin preparation Route of administration Therapeutical formulation 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 2026 Expected Registration August 2026 Orphan drug No 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 NCT06269107 (COMBINE 4) 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