BRINSUPRI Film-coated tablet Ref.[116035] Active ingredients: Brensocatib

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands

Product name and form

Brinsupri 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Grey, approximately 9 mm diameter round tablet debossed with "25" on one side and "BRE" on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 25 mg of brensocatib (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient

Brensocatib is a competitive and reversible inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 activates pro-inflammatory neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow. Brensocatib reduces the activity of NSPs implicated in the pathogenesis of bronchiectasis, including neutrophil elastase, cathepsin G and proteinase 3.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Calcium hydrogen phosphate dihydrate
Sodium starch glycolate
Silica, colloidal hydrated
Glycerol dibehenate

Film-coating:

Poly(vinyl alcohol)
Titanium dioxide (E171)
Macrogol 4000 (MW 3350)
Talc
Black iron oxide (E172)

Pack sizes and marketing

PVC/PCTFE aluminium foil blister card containing 14 film-coated tablets.

Pack size of 28 tablets (2 blister cards of 14 tablets each) in a carton.

Marketing authorization holder

Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands

Marketing authorization dates and numbers

EU/1/25/1995/001

Drugs

Drug Countries
BRINSUPRI Lithuania, United States

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