Is Brensocatib approved by the US FDA?

Drugs@FDA lists 1 application product line for Brensocatib, including BRINSUPRI (Prescription).

Is Brensocatib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Brensocatib: Brinsupri.

Active substance

Brensocatib

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BRINSUPRI	10MG; 25MG	tablet · oral	INSMED INC	Prescription	12 Aug 2025

EMA European Union — centrally authorised medicines

Brinsupri Insmed Netherlands B.V. · Authorised · authorised 18 Nov 2025 · ATC R03

Therapeutic indication (EMA)

Brinsupri is indicated for the 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.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.