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Ibrexafungerp

Extended indication Invasive Candidiasis
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Ibrexafungerp
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Infectious diseases other
Extended indication Invasive Candidiasis
Manufacturer Scynexis
Mechanism of action Enzyme inhibitor
Route of administration Oral
Budgetting framework Extramural (GVS)
Additional remarks SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Registration phase Clinical trials

Therapeutic value

Current treatment options echinocandinen
Therapeutic value No judgement
Substantiation Scynexis: SCY-078 has shown activity against Aspergillus and Candida, including against multidrug-resistant (MDR) species Candida auris as well as Pneumocystis. Orale toediening kan mogelijk ook voordelen opleveren t.o.v. bestaande behandelmethoden.
References Scynexis en de klinische studies: CARES, FURI.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional remarks Huidige behandelopties kosten rond de €400,00 per 100 mg poeder voor oplossing.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References clinicaltrials.gov
Additional remarks Op dit moment niet voor andere indicaties in fase III van het klinisch onderzoek.

Other information

There is currently no futher information available.