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Brilacidin

Extended indication Mucositis in head and neck cancer
Therapeutic value No judgement yet
Registration phase Clinical trials

Product

Active substance Brilacidin
Domain Oncology and Hematology
Main indication Head and neck cancer
Extended indication Mucositis in head and neck cancer
Manufacturer Innovation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks First-in-class a synthetic, small-molecule defensin-mimetic, for treatment of bacterial infections.

Registration

Registration route Centralised (EMA)
Particularity New medicine
Orphan drug No
Registration phase Clinical trials
Additional remarks Scrip pipeline watch 8 jan 2018: Delayed onset of severe oral symptoms. Updated Phase III Results.

Therapeutic value

Current treatment options Momenteel geen behandeling
Therapeutic value No judgement yet
Substantiation Beperkte informatie beschikbaar
Frequency of administration 3 times a day
Dosage per administration 3mg/ml
References NCT02324335
Additional remarks De studie NCT02324335 heeft een behandelduur van 7 weken.

Expected patient volume per year

References NKR; Oncoline
Additional remarks In 2015 werden 1899 patiënten met hoofd- en halstumoren behandeld met radiotherapie. Bij 80-100% van deze patiënten treedt mucositis op als bijwerking van deze behandeling, dit bedraagt dus 1519-1899 patiënten.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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 Yes
Indication extensions Skin Infection (Bacterial Infection)
References Clinicaltrials.gov

Other information

There is currently no futher information available.