Is Brensocatib Available in the USA? Understanding Its FDA Approval and Access

October 11, 2025 •

2 min read

On August 12, 2025, the U.S. Food and Drug Administration (FDA) approved Brensocatib, brand name Brinsupri, as the first-ever treatment for non-cystic fibrosis bronchiectasis (NCFB). This landmark decision means that yes, is Brensocatib available in the USA, offering a new targeted therapy option for patients aged 12 and older with this chronic lung disease.

Quick Summary

Following FDA approval in August 2025, the new drug Brinsupri (Brensocatib) is now available in the U.S. for adults and adolescents with non-cystic fibrosis bronchiectasis (NCFB) via a specialty pharmacy network. The medication works by inhibiting inflammation to reduce pulmonary exacerbations.

Key Points

FDA Approval: Brensocatib, marketed as Brinsupri, received FDA approval in August 2025 for non-cystic fibrosis bronchiectasis (NCFB).
Availability: The medication is available in the USA through a specialized pharmacy network for eligible patients.
Mechanism of Action: It is a DPP1 inhibitor that reduces inflammation by blocking the activation of neutrophil serine proteases.
Indication: Brinsupri is indicated for adults and adolescents (12+) with NCFB.
Clinical Benefits: Studies showed that brensocatib reduced the rate of pulmonary exacerbations and, with the higher dose, slowed the rate of lung function decline.
Distribution: Patients must obtain the medication through specialty pharmacies like PANTHERx Rare Pharmacy or Amber Specialty Pharmacy.
Considerations: Potential side effects include upper respiratory infection, headache, rash, and skin thickening (hyperkeratosis); live vaccines should be avoided.

The Landmark FDA Approval of Brensocatib

Before the FDA approval of brensocatib (Brinsupri) on August 12, 2025, there were no approved therapies specifically for non-cystic fibrosis bronchiectasis (NCFB). Developed by Insmed, Brinsupri is now indicated for adults and adolescents (12 years and older) with NCFB. This approval is a significant advancement in treating NCFB, providing a targeted therapy to reduce exacerbations. The approval was based on clinical trial data, including the Phase 3 ASPEN study, which demonstrated that brensocatib reduced the rate of pulmonary exacerbations compared to a placebo.

Understanding Brensocatib's Mechanism of Action

Brensocatib is a first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). It targets a key mechanism driving chronic inflammation in NCFB, specifically by inhibiting DPP1, an enzyme that activates neutrophil serine proteases (NSPs). In NCFB, excessive active NSPs contribute to lung damage and inflammation. By blocking DPP1, brensocatib prevents the activation of these proteases, reducing inflammation and exacerbations and potentially slowing lung function decline.

Navigating Availability and Access in the USA

Brinsupri is available in the U.S. through a specialty pharmacy network. Patients cannot get the medication at regular pharmacies. Specialty pharmacies offer support services, including help with insurance and patient assistance programs.

Specialty Pharmacy Network Providers

PANTHERx Rare Pharmacy
Amber Specialty Pharmacy

Patients should work with their doctor to access Brinsupri through one of these pharmacies. While the annual list price is around $88,000, insurance coverage and patient programs are important for affordability.

Comparing Brensocatib with Conventional Bronchiectasis Treatments


Feature	Brensocatib (Brinsupri)	Conventional Treatments (e.g., Macrolides, Airway Clearance)
Mechanism	Targets a root cause of inflammation by inhibiting DPP1 and NSPs.	Manages symptoms, reduces bacterial load (antibiotics), or clears mucus.
Therapeutic Goal	Reduce exacerbation frequency, slow lung function decline.	Control symptoms and prevent infections.
Formulation	Oral tablets, once-daily dosing.	Oral tablets (antibiotics) or inhaled solutions.
Patient Profile	Adults and adolescents (12+) with NCFB and frequent exacerbations.	Patients with NCFB experiencing symptoms or infections.
Efficacy Data	Phase 3 ASPEN showed significant reduction in exacerbations and slowed lung function decline (25mg dose).	Varies based on patient and specific regimen; aims to manage infections and symptoms.

Considerations and Potential Side Effects

Brensocatib was generally well-tolerated in clinical trials. Common side effects included upper respiratory tract infection, headache, rash, dry skin, skin thickening (hyperkeratosis), and high blood pressure. Dermatologic and periodontal issues were also observed. It is recommended that patients avoid live vaccines while taking brensocatib. Patients should discuss potential risks and benefits with their doctor.

Conclusion: A New Era for NCFB Treatment

The FDA approval and availability of brensocatib (Brinsupri) in the USA is a major development for NCFB treatment. As the first targeted therapy, it offers a new approach by addressing the underlying inflammation rather than just symptoms. This could help slow disease progression, reduce exacerbations, and improve quality of life for adults and adolescents with NCFB. The introduction of brensocatib has the potential to change the standard of care for this condition. More details on supporting clinical trials can be found on ClinicalTrials.gov.

Frequently Asked Questions

Brensocatib, under the brand name Brinsupri, was approved by the U.S. Food and Drug Administration (FDA) on August 12, 2025.

Brinsupri (brensocatib) is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older.

Brensocatib is administered as a once-daily oral tablet, which can be taken with or without food.

Brensocatib is a dipeptidyl peptidase 1 (DPP1) inhibitor that works by blocking the activation of neutrophil serine proteases, which are key drivers of inflammation in NCFB.

In the U.S., Brensocatib is distributed through a specialty pharmacy network. Patients must get a prescription from their healthcare provider and work with a designated specialty pharmacy to access the medication.

Common side effects include upper respiratory tract infection, headache, rash, dry skin, skin thickening (hyperkeratosis), and hypertension.

No, Brensocatib is not a cure, but it is the first targeted therapy designed to treat the underlying inflammation of NCFB, reducing exacerbations and slowing disease progression, offering a significant advancement in management.

No, Brensocatib is not approved for cystic fibrosis. Clinical trials specifically excluded patients with cystic fibrosis or certain immunodeficiency disorders.