Brinsupri FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 12, 2025.
FDA Approved: Yes (First approved August 12, 2025)
Brand name: Brinsupri
Generic name: brensocatib
Dosage form: Tablets
Company: Insmed Incorporated
Treatment for: Bronchiectasis
Brinsupri (brensocatib) is a dipeptidyl peptidase 1 inhibitor for the treatment of patients with bronchiectasis.
- Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.
- Bronchiectasis is chronic lung disease characterized by permanent dilation of the bronchi due to a cycle of infection, inflammation, and lung tissue damage. A distinctive characteristic of bronchiectasis is frequent exacerbations, or flares, when symptoms worsen, such as coughing, increased mucus, shortness of breath and fatigue.
- Brinsupri contains brensocatib, which is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. Neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation in chronic inflammatory lung diseases. Brensocatib is thought to work to decrease the damaging effects of bronchiectasis and other neutrophil-driven inflammatory conditions by inhibiting DPP1 and its activation of NSPs.
- FDA approval of Brinsupri was based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies. In the ASPEN study, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in annual rate of exacerbations respectively, as compared to placebo.
- Brinsupri tablets are administered orally once daily with or without food.
- Warnings and precautions associated with Brinsupri include dermatologic adverse reactions, and gingival and periodontal adverse reactions.
- Common adverse reactions (incidence >2%) include upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension.
- Brensocatib is also being studied for use in the treatment of patients with chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases.
Development timeline for Brinsupri
Further information
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