Brensocatib FDA Approval Status
Last updated by Judith Stewart, BPharm on Feb 19, 2025.
FDA Approved: No
Generic name: brensocatib
Company: Insmed Incorporated
Treatment for: Bronchiectasis
Brensocatib is a dipeptidyl peptidase 1 inhibitor in development for the treatment of patients with bronchiectasis.
- Bronchiectasis is chronic lung disease characterized by permanent dilation of the bronchi due to a cycle of infection, inflammation, and lung tissue damage. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition.
- Brensocatib 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.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for brensocatib for use in patients with non-cystic fibrosis bronchiectasis. The FDA has granted Priority Review to the NDA and has set a target action date of August 12, 2025.
- Brensocatib is also being developed for the treatment of patients with chronic rhinosinusitis without nasal polyps, hidradenitis suppurativa, and other neutrophil-mediated diseases.
Development timeline for brensocatib
Further information
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