Mark Metersky, MD, FCCP

A year after the US Food & Drug Administration approved brensocatib (Brinsupri) as the first disease-modifying therapy for non-cystic fibrosis bronchiectasis, pulmonologists are refining which patients benefit most while reporting a tolerability profile that has not deterred uptake.

The FDA approved brensocatib for non-cystic fibrosis bronchiectasis on August 12, 2025. The decision was based on the phase 3 ASPEN trial, which enrolled > 1700 patients and showed both the 10 mg and 25 mg doses of brensocatib reduced annualized exacerbation rates by 20% compared with placebo. The 25 mg dose also showed lung function decline over 12 months.¹

bensocatib Patient Selection Evolves 1 Year After FDA Approval

Bensocatib Patient Selection Evolves 1 Year After FDA Approval

Mark L. Metersky, MD, FCCP, FACP, professor of medicine and director of the Center for Bronchiectasis Care at UConn Health, has prescribed brensocatib since its approval and shared his approach to patient selection and tolerability in an interview with 

"Bronchiectasis is quite heterogeneous, so it's likely not every patient will benefit," Metersky said. "For me, what I'm doing is using it in patients who have frequent exacerbations."

Brensocatib Patient Selection and ASPEN Trial Data

The ASPEN trial randomized patients with non-cystic fibrosis bronchiectasis to 10 mg brensocatib, 25 mg brensocatib, or placebo for 52 weeks across international sites. Both doses met the primary endpoint of a reduced annualized exacerbation rate compared with placebo, and the 25 mg dose additionally slowed the rate of forced expiratory volume in 1 second (FEV1) decline.¹

Metersky said patients with a high daily symptom burden, such as frequent cough with copious purulent sputum despite an absence of frequent exacerbations, may also derive benefit based on the drug's mechanism of action and the pattern of trial results. He added patients with rapidly declining lung function are additional potential candidates, given the 25 mg dose's demonstrated effect on FEV1 decline, though data specific to this subgroup remain unavailable.

Brensocatib Safety Profile and Patient Tolerability

Brensocatib (Brinsupri) is approved by the FDA as a disease-modifying therapy for non-cystic fibrosis bronchiectasis in patients 12 years and older, based on results from the phase 3 ASPEN trial.

Brensocatib is an oral, reversible inhibitor of dipeptidyl peptidase-1 (DPP-1), an enzyme responsible for activating neutrophil serine proteases implicated in bronchiectasis airway inflammation.

Which bronchiectasis patients are most likely to benefit from brensocatib? 

Metersky prioritizes patients with frequent exacerbations, the population studied in ASPEN, and considers patients with a high daily symptom burden or rapidly declining lung function additional potential candidates, though these groups were not directly studied in the trial.

The most common adverse events in ASPEN were consistent with the safety profile observed in earlier studies, and the phase 3 trial did not show a significant signal for increased periodontal disease risk with brensocatib.¹ Metersky said the drug's distinctive tolerability profile, including hyperkeratosis and periodontal changes, has not deterred patients from starting or continuing therapy in his practice.

He recalled one patient who asked if her teeth would fall out before starting treatment.

"That's not been an issue patients fear," said Metersky. "In truth, we didn't really see a significant signal for increased risk of periodontal disease in the phase 3 study."

He advises patients to brush twice daily, floss, and see their dentist regularly, noting any periodontal changes would likely develop slowly and be caught early. Metersky said he has also observed skin thickening and sloughing, most often behind the knees, elbows, feet, and hands, in one patient, but described the finding as uncommon in his experience.

The 1-year mark followed the American College of Chest Physicians' first North American clinical practice guideline for adult bronchiectasis, published in 2026, which includes long-term brensocatib among 13 conditional recommendations for patients with frequent exacerbations.³ Even with an approved therapy and dedicated guideline, unmet needs such as chronic cough, sputum burden, and disease progression persist across the bronchiectasis population.⁴

Watch the accompanying dynamic feature here: 

One Year Later: How Brensocatib Has Changed Bronchiectasis Care

Chalmers JD, et al. Phase 3 trial of the DPP-1 inhibitor brensocatib in bronchiectasis. 

FDA approves first bronchiectasis therapy, brensocatib, for ages 12 and up. HCPLive. Published August 12, 2025. Accessed August 21, 2026. 

https://www.hcplive.com/view/fda-approves-first-bronchiectasis-therapy-brensocatib-12-up

CHEST guideline 2026: 13 recommendations for non-CF bronchiectasis. HCPLive. Accessed August 21, 2026. 

https://www.hcplive.com/view/chest-guideline-2026-13-recommendations-bronchiectasis

Metersky M, Basavaraj A, Johnson V. One year later: how brensocatib has changed bronchiectasis care. HCPLive. Accessed August 21, 2026. 

https://www.hcplive.com/view/one-year-later-how-brensocatib-has-changed-bronchiectasis-care

Videos

One year after FDA approval, Mark Metersky, MD, discusses which bronchiectasis patients benefit most from brensocatib and its safety profile.

Brensocatib Patient Selection Evolves 1 Year After FDA Approval

On August 12, 2025, the United States Food and Drug Administration 

approved Insmed’s brensocatib (Brinsupri)

, marking the first disease-modifying therapy for non–cystic fibrosis bronchiectasis.

The approval, based on the phase 3 ASPEN trial enrolling more than 1700 patients, showed that both the 10-mg and 25-mg doses of brensocatib—an oral, reversible inhibitor of dipeptidyl peptidase-1 that dampens neutrophil-driven airway inflammation—reduced annualized exacerbation rates by 20% compared with placebo, with the higher dose also slowing lung function decline over 12 months.

 spoke with 2 pulmonologists who have been prescribing the therapy since its approval about what has changed in day-to-day management of a disease that, until recently, had no targeted treatment options at all.

Mark L. Metersky, MD, FCCP, FACP, professor of medicine and director of the Center for Bronchiectasis Care at UConn Health, said the drug has been well received by patients, many of whom had followed its development before approval. Most patients report subjective improvement, with less coughing, easier sputum clearance, and less discoloration.

“I think that the study results suggest that even in patients who may not have frequent exacerbations but have poor quality of life due to severe symptoms, that there may be benefit in those patients, although clearly it was not tested in such patients. But if you look at the pathophysiology and the way the drug works, and the results of the studies, it looks promising for patients such as those who have a lot of symptoms,” Metersky said. Also, patients who are rapidly losing lung function, since we know that the higher dose slows down the loss of lung function - those are patients in my mind that should be potential candidates for the drug.”

Ashwin Basavaraj, MD, FCCP, ATSF, section chief of pulmonary, critical care, and sleep medicine at NYC Health + Hospitals and director of the Bronchiectasis and NTM Program at NYC Health + Hospitals/Bellevue, echoed that sentiment, describing the past year as an exciting period for a field that had gone decades without a dedicated therapy.

The 1-year anniversary also followed shortly after the American College of Chest Physicians' first North American clinical practice guideline for adult bronchiectasis, published in 2026, which includes long-term brensocatib among 

 for patients with frequent exacerbations.

 Metersky noted that the guideline fills gaps left by earlier documents produced before the drug's approval, though he emphasized that meaningful unmet needs—chronic cough, sputum burden, and disease progression—persist even with expanded treatment options.

Patient selection remains an evolving question, particularly regarding nontuberculous mycobacteria (NTM), which Basavaraj noted affects roughly half of bronchiectasis patients in the US, a substantially higher proportion than in Europe. While NTM is not a contraindication to DPP-1 inhibitor therapy, and Basavaraj reported no signal of worsening infection with brensocatib use, he stressed that outcomes data in this overlapping population are still being collected. Notably, brensocatib's development in other inflammatory indications has not been uniformly successful: a phase 2b trial in hidradenitis suppurativa failed to meet its efficacy endpoints in 2026, leading the manufacturer to discontinue that program, underscoring that its benefit to date is specific to bronchiectasis.

On tolerability, Metersky said the drug's distinctive adverse event profile—including periodontal and skin changes—has not been a significant barrier to uptake in his practice, with the phase 3 trial data showing no significant periodontal disease signal and skin changes remaining uncommon. One year on, both physicians describe a field that has gained its first genuine treatment option, alongside a clearer, though still incomplete, picture of who benefits most.

Basavaraj and Metersky’s disclosures include Insmed and others. 

FDA approves first bronchiectasis therapy, brensocatib, for ages 12 and up. HCPLive. Accessed August 11, 2026. 

CHEST guideline 2026: 13 recommendations for non-CF bronchiectasis. HCPLive. Accessed August 11, 2026. 

Brensocatib phase 2b study in HS does not meet endpoints, program discontinued. HCPLive. Accessed August 11, 2026. 

https://www.hcplive.com/view/brensocatib-phase-2b-study-hs-does-not-meet-endpoints-program-discontinued

Mark Metersky, MD, and Ashwin Basavaraj, MD, discuss novel therapy brensocatib on the 1-year anniversary of its FDA approval.

In "The Future of Bronchiectasis Care: Precision Medicine Ahead," the panel closes the series with its outlook on where bronchiectasis care is headed next.

The Future of Bronchiectasis Care: Precision Medicine Ahead

In a closing round, Dr. Basavaraj asks each panelist what excites them most about the future of bronchiectasis care. Dr. Metersky points to two converging trends: increasing incidental diagnosis through imaging obtained for unrelated reasons, and growing general awareness of the disease, both of which should allow earlier intervention before patients become severely symptomatic. He also highlights a robust and diverse therapeutic pipeline, spanning anti-inflammatory agents, novel biofilm-targeting compounds, and monoclonal antibodies directed at bacteria, alongside growing understanding of disease endotypes.

Dr. ElMaraachli emphasizes that the success of DPP1 inhibition validates an entirely new therapeutic strategy: targeting the underlying pathophysiology of bronchiectasis rather than only managing its consequences. He believes this validation has opened the door for the additional anti-inflammatory therapies currently in earlier-phase development. He also highlights a broader shift in clinical thinking, from simply confirming a bronchiectasis diagnosis toward characterizing which endotype a given patient has, moving the field closer to genuinely personalized, precision-based treatment selection.

Dr. Khabbaza says he is encouraged simply by how much more bronchiectasis is discussed across medicine now, crediting recent educational campaigns around brensocatib's launch with raising awareness among providers. He compares the trajectory to asthma and COPD, fields where multiple biologic options eventually allowed clinicians to target specific inflammatory pathways, and expresses hope that treating inflammation earlier, whether eosinophilic or neutrophilic, may ultimately modify long-term disease course.

Dr. ElMaraachli adds that the growing bronchiectasis and NTM care center network represents an important parallel effort to standardize care delivery worldwide. Dr. Metersky closes by noting that brensocatib's approval matters beyond its individual efficacy, since it demonstrates a viable regulatory pathway for bronchiectasis drugs after years of high-profile late-phase failures had discouraged pharmaceutical investment in the space.

Thank you for watching this HCPLive Peer Exchange series on bronchiectasis. Please subscribe to our eNewsletter for information on upcoming video series.

A more precise, endotype-driven understanding of bronchiectasis, paired with an expanding treatment pipeline, is reshaping expectations for what long-term disease control can look like.

"Bringing Bronchiectasis Guidelines Into Everyday Practice" takes up the practical hurdles of translating new bronchiectasis guidelines into day-to-day patient care.

Bringing Bronchiectasis Guidelines Into Everyday Practice

Dr. Basavaraj asks Dr. Khabbaza what challenges he anticipates in translating the new CHEST guidelines into everyday clinical practice. Dr. Khabbaza notes that a gap between guideline publication and routine bedside adoption is typical of any new guidance, and he expects the underlying knowledge gap to remain a central obstacle. He observes that even patients correctly labeled with bronchiectasis are sometimes still managed as though they have asthma or COPD, reflecting treatment inertia that persists even once terminology improves. He credits growing patient and provider awareness, including direct-to-consumer education, with moving the field in the right direction, but cautions that many clinicians lack hands-on experience with newer modalities such as inhaled antibiotics or tranexamic acid, which involve more operational complexity than writing a standard prescription. He recommends that community physicians partner with bronchiectasis care centers for initial guidance while directly managing components themselves to build practical experience over time.

Dr. Metersky adds that reducing the burden on physicians is equally important to successful implementation. He points to time-intensive tasks such as patient education for airway clearance and prior authorization paperwork, both of which can be delegated to a nurse practitioner or respiratory therapist and dedicated nursing staff, freeing physicians to focus where their expertise is most needed. Dr. Khabbaza adds that portal-delivered educational videos are a valuable adjunct, allowing patients and families to review material together outside the office visit.

Dr. Basavaraj notes that published guidelines are inherently limited to what available evidence supports, and highlights the Bronchiectasis and NTM Association's planned clinical consensus statements as a complementary resource. Dr. ElMaraachli frames these statements as practical, experience-based guidance from high-volume centers addressing questions where formal evidence remains too thin to support a guideline recommendation.

Up next, in the final episode, "The Future of Bronchiectasis Care: Precision Medicine Ahead," the panel shares its outlook on the future of bronchiectasis care.

Turning new bronchiectasis guidelines into everyday practice demands more than awareness, requiring hands-on familiarity with unfamiliar therapies and dedicated staff to share the treatment burden.

Mark Metersky, MD, FCCP

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