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FDA Medication Tracker

← All approvals · Kidney, liver & lung · 2025

Brinsupri (brensocatib)

The FDA approved Brinsupri (brensocatib) on August 12, 2025 to treat non-cystic fibrosis bronchiectasis.
Brand name
Brinsupri
Generic name
brensocatib
FDA approval date
August 12, 2025
Approved use (FDA wording)
To treat non-cystic fibrosis bronchiectasis
Company
Insmed Inc.
Application
NDA217673
Dosage form / route
TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Kidney, liver & lung

Indications and usage, from the FDA label

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.