Contezolid Medicine 03 June 2025 Extended indication Contezolid monotherapy for the treatment of moderate or severe diabetic foot infection in adults and the elderly without concomitant osteomyelitis. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Contezolid Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Contezolid monotherapy for the treatment of moderate or severe diabetic foot infection in adults and the elderly without concomitant osteomyelitis. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Micurx Portfolio holder Mechanism of action Antihistamine 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 September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT05369052 Therapeutic value Current treatment options Tedizolid, linezolid Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit middel is vergelijkbaar met linezolid. Er zijn mogelijk minder bijwerkingen, maar dit moet nog blijken uit onderzoek. Mogelijk is er een plaats voor (langdurige) behandeling van mycobacteriële (MDR) infecties. Duration of treatment Frequency of administration Dosage per administration Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses) References NCT05369052; Expertopinie Additional remarks Expected patient volume per year Patient volume < 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Het patiëntvolume wordt ingeschat op ongeveer 300. Expected cost per patient per year Cost References Additional remarks Er is nog niets bekend over de mogelijke prijs. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Expertopinie Additional remarks Er is een grote kans op off-label gebruik. Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks