Ensitrelvir Medicine 03 June 2025 Extended indication Treatment of coronavirus disease 2019 (COVID-19). Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registration application pending Product Active substance Ensitrelvir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Treatment of coronavirus disease 2019 (COVID-19). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Shionogi Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration August 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks NCT05897541; NCT05305547 Therapeutic value Current treatment options Paxlovid Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Paxlovid (ritonavir-boosted nirmatrelvir) is een proteaseremmer die werkzaam is tegen SARS-CoV-2. Ensitrelvir is een nieuwe proteaseremmer die ook werkzaam is tegen SARS-CoV-2. Een belangrijk nadeel van Paxlovid is dat de ritonavir component een sterke remmer is van CYP3A4 en daardoor veel drug-drug interacties geeft. Ensitrelvir wordt niet geboost door ritonavir maar is zelf ook een sterke remmer van CYP3A4. De verwachting is dus dat het middel ensitrelvir ook significante drug-drug interacties heeft. Duration of treatment Average 5 day / days Frequency of administration Dosage per administration References NCT05897541; Expertopinie 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks