What Is the New Medicine for Bronchiectasis? A Look at Brinsupri (brensocatib)

October 12, 2025 •

3 min read

In a major advancement for respiratory medicine, the U.S. Food and Drug Administration (FDA) officially approved the first-ever treatment specifically for bronchiectasis in August 2025. This groundbreaking new medicine for bronchiectasis is called Brinsupri (brensocatib), an oral medication that represents a significant shift from previous symptom-focused management strategies by directly addressing a root cause of inflammation.

Quick Summary

The new FDA-approved oral medicine for non-cystic fibrosis bronchiectasis is Brinsupri (brensocatib). It works by inhibiting the DPP1 enzyme, which reduces harmful neutrophilic inflammation and significantly lowers the frequency of pulmonary flare-ups. Clinical trial data support its efficacy in reducing exacerbations and slowing lung function decline in eligible adult and adolescent patients.

Key Points

First FDA-Approved Drug: Brinsupri (brensocatib) is the first medication specifically approved by the FDA for the treatment of non-cystic fibrosis bronchiectasis in adults and adolescents aged 12 and older.
Targets Inflammation: The drug works by inhibiting the DPP1 enzyme, which reduces the activity of neutrophil serine proteases that drive the harmful inflammatory cycle in the lungs.
Reduces Exacerbations: In clinical trials, brensocatib significantly lowered the annual rate of pulmonary exacerbations (flare-ups) compared to a placebo.
Slows Lung Decline: The 25 mg dose of brensocatib demonstrated a slower rate of lung function decline (measured by FEV1) in trial participants.
Complements Traditional Care: Brensocatib is expected to be integrated with current treatment strategies, including airway clearance and antibiotics, to provide a more targeted therapeutic approach.
Associated Side Effects: Common adverse effects noted in trials include mild skin thickening (hyperkeratosis) and dental issues like periodontitis.
Considerable Cost: With a high annual list price, the accessibility and insurance coverage of brensocatib will be a significant factor for patients.

The Breakthrough: Brinsupri (brensocatib)

Before the recent approval, individuals with non-cystic fibrosis bronchiectasis (NCFB) relied on supportive care, including antibiotics and airway clearance, as no specific treatment existed for the condition itself. Brinsupri (brensocatib) has changed this landscape, receiving FDA approval as the first oral medication for NCFB in August 2025. This development is a significant step forward for the hundreds of thousands affected by NCFB in the U.S..

How Brensocatib Works: Targeting the Inflammatory Cycle

Bronchiectasis is characterized by a cycle of infection, inflammation, and lung damage. Neutrophils, a type of white blood cell, release neutrophil serine proteases (NSPs) that contribute to this damage. Brensocatib works by inhibiting dipeptidyl peptidase 1 (DPP1), an enzyme essential for activating NSPs. By blocking DPP1, brensocatib reduces NSP activity and subsequent inflammation, helping to decrease pulmonary exacerbations.

Key Clinical Trial Results: The ASPEN Study

The FDA's decision was largely based on the Phase 3 ASPEN trial, which involved over 1,700 NCFB patients. The trial compared daily doses of 10 mg and 25 mg of brensocatib to a placebo over 52 weeks. Key findings published in the New England Journal of Medicine include a lower rate of exacerbations requiring antibiotics and a longer time before the first exacerbation in patients treated with brensocatib. Additionally, more patients on brensocatib remained exacerbation-free, and the 25 mg dose was linked to a slower decline in lung function (FEV1). Patients also reported an improved quality of life.

Potential Side Effects

Common adverse effects observed during clinical trials included mild skin thickening (hyperkeratosis) and an increased incidence of dental issues such as periodontitis or gingivitis. These were generally not severe enough to cause patients to stop treatment.

Incorporating Brensocatib into Care

Brensocatib is expected to change the management of NCFB by adding a treatment that addresses the underlying inflammation. While current treatments focus on symptoms, brensocatib offers a preventative approach that may be used alongside therapies like long-term macrolide antibiotics for patients with frequent flare-ups. Clinical guidelines will help determine the best way to integrate this new therapy.

Comparison of Treatment Approaches


Feature	Brinsupri (brensocatib)	Traditional Treatment
Mechanism	Oral DPP1 inhibitor; reduces neutrophilic inflammation and protease activity.	Primarily antibiotics (oral, inhaled) and airway clearance; manages infections and mucus.
Primary Goal	Reduce frequency of exacerbations and slow disease progression.	Control symptoms, clear mucus, and treat infections.
Administration	Once-daily oral pill.	Varies, including oral antibiotics, inhaled antibiotics, and physical therapy.
Target	Underlying inflammatory process.	Consequences of the disease cycle (infection, mucus buildup).
Cost	Significantly higher annual cost ($88,000 annual list price).	Varies widely, generally lower than Brinsupri.
Side Effects	Increased risk of mild skin thickening and dental issues.	Varies by treatment; antibiotics can lead to resistance or gastrointestinal issues.

Future Directions and Remaining Challenges

The approval of brensocatib is a significant step, but research continues to address the substantial needs in bronchiectasis care. Other potential treatments are in development, including different DPP1 inhibitors and therapies targeting specific infections like Pseudomonas aeruginosa. Ongoing studies will help refine how brensocatib is used, determine which patients benefit most, and address the challenges of cost and access. Collaboration among stakeholders is crucial to improve care for people with bronchiectasis. For details on the ASPEN trial, refer to the New England Journal of Medicine.

Conclusion

Brinsupri (brensocatib) represents a major advance for those with bronchiectasis, offering the first treatment that targets the disease's underlying inflammatory mechanisms. This novel approach can reduce exacerbations and potentially slow disease progression, providing a new option for patients. While the cost and integration into existing care require consideration, brensocatib is a critical development that opens the door for further therapeutic innovation in bronchiectasis care.

Frequently Asked Questions

Brinsupri (brensocatib) is the brand name for a new once-daily oral medication approved by the FDA in August 2025 for treating non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older.

Brensocatib works by inhibiting the enzyme dipeptidyl peptidase 1 (DPP1). This action reduces the activation of neutrophil serine proteases, which are key drivers of inflammation and tissue damage in bronchiectasis.

Based on the FDA approval, Brinsupri is indicated for adults and adolescents aged 12 and older with non-cystic fibrosis bronchiectasis who have a history of frequent pulmonary exacerbations.

Clinical trials reported that common side effects include mild skin thickening (hyperkeratosis) and dental issues such as periodontitis or gingivitis. These effects were generally mild.

Unlike traditional treatments that focus on managing symptoms with antibiotics and airway clearance, brensocatib is the first drug approved to address the underlying inflammatory cause of the disease, aiming to prevent flare-ups rather than just treating them.

Yes, brensocatib has a high list price. The annual cost has been announced at $88,000, which will likely prompt insurers to restrict its use to specific cases.

Yes, the pipeline includes several other investigational therapies. These include other DPP1 inhibitors like HSK31858 and phage therapies such as AP-PA02 for chronic infections.