Ensitrelvir Medicine 03 June 2025 Extended indication Ensitrelvir monotherapy for the preventive treatment of symptomatic SARS-CoV-2 infection in children, adolescents, adults and the elderly who are household contacts of a person with symptomatic COVID-19. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ensitrelvir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Ensitrelvir monotherapy for the preventive treatment of symptomatic SARS-CoV-2 infection in children, adolescents, adults and the elderly who are household contacts of a person with symptomatic COVID-19. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Shionogi Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks fabrikant: Shionogi Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration March 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT05897541 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Lijkt op paxlovid (enige orale middel tegen COVID) wat veel interacties heeft in toevoeging donavir. Als dit nieuwe product die nieuwe interacties niet heeft dan van meerwaarde maar dat lijkt niet het geval. Duration of treatment Average 5 day / days Frequency of administration Dosage per administration References NCT05897541 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks De verwachting is dat er zeer weinig patiënten in aanmerking zullen komen. 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 Other information Additional remarks