MedeliX
Start asking

brensocatib

Brinsupri · ATC code R03

Also known as: Brensokatib

Key facts
Active substance
brensocatib
ATC code
R03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Brinsupri 25 mg film-coated tablets
Marketing authorisation holder
Insmed Netherlands B.V.
Information as of
2026-10-28

Key facts

Brensocatib is a dipeptidyl peptidase 1 (DPP1) inhibitor used to treat non-cystic fibrosis bronchiectasis in patients aged 12 years and older (Brinsupri, film-coated tablets).

What it is used for

  • Treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

Dosing

  • Brinsupri: 25 mg orally once daily, with or without food.
  • Missed dose: take the next dose at the regular time the next day; do not double the dose.
  • No dose adjustment in elderly patients or in renal or hepatic impairment.
  • Safety and efficacy in children under 12 years have not been established.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Fungal infections (mainly candida-related) and isolated Aspergillus infections were more frequent with brensocatib 25 mg than placebo (1.5% vs 1.1%).
  • Safety not established in immunocompromised patients; caution with moderate to severe neutropenia (absolute neutrophil count < 1,000/mm³).
  • Live attenuated vaccines should be avoided during treatment.

Side effects

  • Most frequent: headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%) and dry skin (3.0%).
  • Other common reactions: gastroenteritis, gingival disorder, periodontal disease, skin exfoliation, alopecia.

Interactions

  • CYP3A4 induction cannot be excluded; CYP3A4 substrates used in bronchiectasis (e.g. inhaled corticosteroids, macrolide antibiotics, salmeterol, vilanterol) may have lower concentrations and reduced effect.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Breast-feeding: decide between stopping breast-feeding or therapy based on benefit and risk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • BrinsupriInsmed Netherlands B.V. · EMEA/H/C/005820

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Brinsupri
Liechtenstein
Brinsupri
Norway
Brinsupri

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Brinsupri – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/brinsupri-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.