Eprenetapopt Medicine 08 June 2021 Extended indication Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Eprenetapopt Domain Hematology Reason of inclusion New medicine (specialité) Main indication AML / MDS Extended indication Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Aprea Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Apoptosis stimulant; Thioredoxin reductase inhibitor; Tumour suppressor protein p53 stimulant. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug Yes 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 NCT03745716 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Aantal diagnoses myelodysplastisch syndroom in 2016: 737. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Geen andere fase 3 studies die nu lopen (december 2020). Other information Additional remarks