Brensocatib: First Approval.

Brensocatib (BRINSUPRI™), an oral, small molecule, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), is being developed by Insmed Incorporated under license from AstraZeneca for the treatment of neutrophil-mediated diseases, including non-cystic fibrosis bronchiectasis (NCFB), chronic rhinosinusitis without nasal polyps (CRSsNP) and hidradenitis suppurativa (HS). Brensocatib received its first approval on 12 August 2025 in the USA for the treatment of NCFB in adult and paediatric patients 12 years of age and older. Brensocatib received a positive opinion in the EU on 17 Oct 2025 and is also under regulatory review in the UK for this indication. This article summarizes the milestones in the development of brensocatib leading to this first approval for the treatment of NCFB.