Tirbanibuline Medicine 03 June 2025 Extended indication Tirbanibulin monotherapy for treatment of actinic keratosis in adults and elderly who have a treatment field on the face or balding scalp measuring up to approximately 100 cm^2. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tirbanibuline Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Tirbanibulin monotherapy for treatment of actinic keratosis in adults and elderly who have a treatment field on the face or balding scalp measuring up to approximately 100 cm^2. Current proprietary name Already available biosimilars / generics Proprietary name Klisyri Manufacturer Almirall Portfolio holder Mechanism of action Other Route of administration Cutaneous Therapeutical formulation Ointment Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Tubulinepolymerizatie- en src-fosforylatieremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2025 Expected Registration June 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in 2025. 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 Frequency of administration Dosage per administration References NCT05279131 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