Treprostinil Medicine 04 December 2025 Extended indication Treprostinil monotherapy for treatment of idiopathic pulmonary fibrosis in adults over 40 years of age and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Treprostinil Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Lung diseases other Extended indication Treprostinil monotherapy for treatment of idiopathic pulmonary fibrosis in adults over 40 years of age and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Tyvaso Manufacturer United Therapeutics Corporation Portfolio holder Mechanism of action Other, see general comments Route of administration Inhalation Therapeutical formulation Aerosol Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Prostacycline-analoog Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date April 2026 Expected Registration May 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 NCT04708782 (TETON-1); NCT05255991 (TETON-2) 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