What Was Approved?
On August 12, 2025, the U.S. Food and Drug Administration approved Brinsupri (brensocatib) for the treatment of non-cystic fibrosis bronchiectasis in adults and pediatric patients 12 years of age and older.
How Does Brinsupri Work?
Brinsupri is a dipeptidyl peptidase 1, or DPP1, inhibitor.
DPP1 is involved in activating certain neutrophil enzymes that can contribute to airway inflammation and lung damage.
How Is Brinsupri Taken?
The FDA-approved dosage is either:
10 mg or 25 mg by mouth once daily, with or without food.
What Did the Clinical Trials Show?
FDA approval was supported mainly by the ASPEN trial, with additional evidence from the WILLOW study.
The trials evaluated whether Brinsupri could reduce pulmonary exacerbations, which are periods of worsening respiratory symptoms requiring antibiotic treatment.
What Are the Main Safety Considerations?
The FDA label includes warnings for:
- Skin reactions
- Gingival and periodontal problems
- Use of live attenuated vaccines
Regular dental hygiene and appropriate dental follow-up are recommended during treatment.
Common adverse reactions included:
- Upper respiratory tract infection
- Headache
- Rash
- Dry skin
- Hyperkeratosis
- High blood pressure
Bottom Line
Brinsupri (brensocatib) is an FDA-approved once-daily oral treatment for non-cystic fibrosis bronchiectasis in patients age 12 and older.
It provides a new treatment option aimed at reducing pulmonary exacerbations, but skin, dental, and vaccination considerations should be reviewed during therapy.
Sources
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Brinsupri.
- U.S. Food and Drug Administration (FDA) — Brinsupri Prescribing Information, August 2025.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.