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AUG 12 2025
APPROVED · 295 DAYS AGO

Insmed Brinsupri (brensocatib) $INSM

for non-cystic fibrosis bronchiectasis

NDA · Priority Review · Breakthrough · Orphan

FDA approved Brinsupri as the first targeted therapy for non-CF bronchiectasis, addressing a population of ~350,000 US patients previously managed with macrolide antibiotics and supportive care.

About

Non-cystic fibrosis bronchiectasis permanently damages the lungs' airways, causing chronic mucus buildup, infections, and breathing difficulties. Brinsupri (brensocatib) is an oral drug that temporarily blocks DPP-1, an enzyme white blood cells use to activate infection-fighting proteins that can also inflame lung tissue. By dialing down this immune overreaction, the treatment may reduce how often flare-ups occur — potentially helping patients breathe easier between infections.

Pivotal trial

ASPEN Phase 3 completed NCT04594369

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

Source: ClinicalTrials.gov

Also in development