Ibuzatrelvir Medicine 04 June 2026 Extended indication Treatment of COVID-19 in adults who are severely immunocomprimised or adults and adolescents who are not hospitalised but are at risk for severe disease. Therapeutic value Total cost Registration phase Clinical trials Product Active substance Ibuzatrelvir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Treatment of COVID-19 in adults who are severely immunocomprimised or adults and adolescents who are not hospitalised but are at risk for severe disease. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Proteasome inhibitor 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 March 2027 Expected Registration April 2028 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT06679140; NCT07013474 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