Extended indication Treatment of infections caused by Gram-negative organisms (in combination with imipenem and cilastatin).
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Funobactam
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Treatment of infections caused by Gram-negative organisms (in combination with imipenem and cilastatin).
Manufacturer Evopoint
Portfolio holder Evopoint
Route of administration Intravenous
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date March 2026
Expected Registration April 2027
Orphan drug No
Registration phase Clinical trials
Additional remarks Tijdslijn op basis van IHSI-inschatting.

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

References NCT05204368; NCT05204563 (REITAB-2)
Additional remarks Imipenem/cilastatine 500mg/500mg in combinatie met funobactam 250mg intraveneus elke zes uur toegediend over 30 minuten.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information