Brinsupri (brensocatib) / Insmed, AstraZeneca - LARVOL DELTA

FDA approval of brensocatib: a new therapeutic breakthrough in non-cystic fibrosis bronchiectasis. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Bronchiectasis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Brensocatib: First Approval. (PubMed, Drugs) - "Brensocatib received a positive opinion in the EU on 17 Oct 2025 and is also under regulatory review in the UK for this indication. This article summarizes the milestones in the development of brensocatib leading to this first approval for the treatment of NCFB."

Journal • Bronchiectasis • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Immunology • Nasal Polyps • Non‐Cystic Fibrosis Bronchiectasis • Otorhinolaryngology • Pediatrics • Pulmonary Disease • Respiratory Diseases • Sinusitis

Effects of brensocatib on neutrophil serine protease levels in patients with non-cystic fibrosis bronchiectasis: a pharmacodynamic analysis of the ASPEN trial (BTS WM 2025) - P3 | "NSP activity was stably suppressed throughout the treatment period and increased toward baseline after 4 weeks off-treatment. Furthermore, brensocatib 25 mg showed a more pronounced reduction of sputum NSP activity than the 10 mg dose."

Clinical • PK/PD data • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • CTSG • ELANE

Efficacy and safety of DPP-1 inhibitors in bronchiectasis: a GRADE-assessed meta-analysis of randomized controlled trials. (PubMed, Respir Res) - "DPP-1 inhibitors reduce exacerbation frequency, delay time to first exacerbation, and improve respiratory symptoms in bronchiectasis without compromising safety. These findings support their role as a potential disease-modifying therapy in bronchiectasis management. Further long-term studies are warranted to confirm their sustained clinical benefit."

Clinical • Journal • Retrospective data • Review • Bronchiectasis • Inflammation • Pulmonary Disease • Respiratory Diseases

Bronchiectasis Treatment Goals, Unmet Needs, and Emerging Therapies: A Podcast. (PubMed, Pulm Ther) - "In the phase 3, 52-week ASPEN trial, brensocatib significantly reduced exacerbation burden, and the 25-mg dose reduced lung function decline and nominally significantly improved patient-reported symptoms compared with placebo. Additional therapies in development include other DPP1 inhibitors (verducatib and HSK31858) and drugs targeting phosphodiesterase 3/4 inhibition (ensifentrine) and anti-interleukin-33 (itepekimab). Overall, the future is promising for patients with the historically neglected and underdiagnosed disease bronchiectasis, with growing awareness and new therapeutic tools becoming available. Podcast (MP4 81554 KB)."

Journal • Bronchiectasis • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pediatrics • Pulmonary Disease • Respiratory Diseases • IL33

Insmed Incorporated…announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. (PRNewswire) - "This approval is based on a comprehensive scientific evaluation of the marketing authorization application, including data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine...Applications for brensocatib are currently under review with the Medicines and Healthcare products Regulatory Agency in the U.K. and the Pharmaceuticals and Medical Devices Agency in Japan."

EMA approval • Japan filing • MHRA filing • Non‐Cystic Fibrosis Bronchiectasis

On Tuesday, 18 November 2025, Insmed Inc...presented at the Jefferies London Healthcare Conference 2025, showcasing a year marked by significant achievements and strategic developments. (Investing.com) - "The conference highlighted both positive strides, such as the FDA approval of Brensocatib, and cautious notes regarding inventory levels."

Clinical • Non‐Cystic Fibrosis Bronchiectasis

Identification of Marrubiin as a Cathepsin C Inhibitor for Treating Rheumatoid Arthritis. (PubMed, Molecules) - "In vivo study indicated that high-dose marrubiin (IC50 = 30 mg/kg) reduced CTSC and NSPs activities in blood and bone marrow in mice without toxicity, and its efficacy was comparable to that of positive compound AZD7986. In the adjuvant-induced arthritis model, high-dose marrubiin (IC50 = 60 mg/kg) exerted a therapeutic effect by reducing the activities of CTSC and NSPs. These findings indicated marrubiin is a promising natural CTSC inhibitor, which can be used for the treatment of neutrophil-related inflammatory diseases."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CTSC

CEDAR: A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS) (clinicaltrials.gov) - P2 | N=214 | Active, not recruiting | Sponsor: Insmed Incorporated | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology

BiRCh: A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) (clinicaltrials.gov) - P2 | N=288 | Completed | Sponsor: Insmed Incorporated | Active, not recruiting ➔ Completed

Trial completion • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Brensocatib - an editorial on the new chapter in noncystic fibrosis bronchiectasis treatment. (PubMed, Ann Med Surg (Lond)) - "By blocking NSP activation, Brensocatib reduces inflammation and exacerbation. WILLOW and ASPEN trials demonstrated significant improvements in exacerbation rates, lung function decline, and exacerbation-free survival, establishing a novel therapeutic paradigm for this previously undertreated condition."

Journal • Bronchiectasis • Chronic Cough • Cough • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Regulatory submissions for brensocatib for patients with bronchiectasis in the United Kingdom (UK) and Japan have been accepted. (PRNewswire) - "Insmed anticipates commercial launches for the EU, UK, and Japan in 2026, pending approval in each territory...Insmed expects to report topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by early January 2026."

Filing • Launch non-US • P2b data • Bronchiectasis • Immunology • Inflammation

In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). (PRNewswire) - "Insmed now expects to report topline data from CEDAR in the first half of 2026."

P2b data • Hidradenitis Suppurativa

Inflammatory Phenotypes of Bronchiectasis. (PubMed, J Pers Med) - "Targeted novel-agents for this group such as brensocatib (neutrophil protease inhibition) emerge...Bronchiectasis has a spectrum of inflammatory phenotypes with distinct biological and clinical implications. Recognition and better understanding of inflammatory phenotypes in bronchiectasis may enable opportunities for personalized precision medicine through the transition from empirical management to biomarker-guided, personalized care."

Journal • Review • Bronchiectasis • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL5

EFFECT OF BRENSOCATIB ON COMPUTED TOMOGRAPHY OUTCOMES IN PATIENTS WITH NON-CYSTIC FIBROSIS BRONCHIECTASIS: AN ANALYSIS OF THE ASPEN TRIAL (CHEST 2025) - P3 | "Both doses of brensocatib, particularly brensocatib 25mg, showed improvements in some CT endpoints vs placebo. These findings, together with improvements in lung function reported in the primary study, suggest that the impact brensocatib on inflammatory processes may result in structural lung changes. Further studies are needed to understand the implications of these findings."

Clinical • Late-breaking abstract • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

EFFICACY AND SAFETY OF BRENSOCATIB IN PATIENTS OF ASIAN RACE WITH NON-CYSTIC FIBROSIS BRONCHIECTASIS: A SUBGROUP ANALYSIS OF THE ASPEN TRIAL (CHEST 2025) - P3 | "Consistent with the overall study population, both brensocatib doses reduced the annualized exacerbation rate and lung function decline, and improved patient-reported symptoms vs placebo in Asian patients enrolled in ASPEN. CLINICAL IMPLICATIONS: Brensocatib is a selective, reversible DPP1 inhibitor that directly targets neutrophil-mediated inflammation. These results demonstrate that brensocatib has a positive impact in Asian patients with bronchiectasis, consistent with the general ASPEN population, despite differences in baseline characteristics, leading to further understanding of bronchiectasis treatment in this population."

Clinical • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

EFFICACY AND SAFETY OF BRENSOCATIB IN PATIENTS WITH NONCYSTIC FIBROSIS BRONCHIECTASIS AND COMORBID COPD: A SUBGROUP ANALYSIS OF THE ASPEN TRIAL (CHEST 2025) - P3 | "Consistent with the overall study population, brensocatib reduced exacerbation rates regardless of comorbid COPD. Brensocatib 25mg reduced lung function decline in patients with and without comorbid COPD. CLINICAL IMPLICATIONS: Brensocatib is a selective, reversible DPP1 inhibitor that directly targets neutrophil-mediated inflammation."

Clinical • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

EFFECTS OF BRENSOCATIB ON NEUTROPHIL SERINE PROTEASE LEVELS IN PATIENTS WITH NONCYSTIC FIBROSIS BRONCHIECTASIS: AN ANALYSIS OF THE ASPEN TRIAL (CHEST 2025) - P3 | "Pharmacodynamic analyses showed that, consistent with the phase 2 WILLOW trial, brensocatib treatment generally resulted in a dose-dependent reduction of NSP activity within 4 weeks. NSP activity was stably suppressed throughout the treatment period and increased toward baseline after 4 weeks off-treatment. Furthermore, brensocatib 25mg showed a more pronounced reduction of sputum NSP activity than the 10mg dose."

Clinical • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • CTSG • ELANE

CHANGES IN SYMPTOM BURDEN DURING PULMONARY EXACERBATIONS IN PLACEBO-TREATED PATIENTS WITH NONCYSTIC FIBROSIS BRONCHIECTASIS: A POSTHOC ANALYSIS FROM THE ASPEN TRIAL (CHEST 2025) - P3 | "Brensocatib, an oral, selective, competitive, and reversible inhibitor of dipeptidyl peptidase 1, prevents activation of neutrophil serine proteases associated with bronchiectasis disease progression... Overall BEST and individual symptom diary scores were increased before and after onset of a PEx, regardless of severity; however, patients with severe PEx experienced a greater symptom burden and longer duration of PEx-related symptoms. Higher symptom burden during severe PEx was driven by breathlessness, fatigue, cough, and cold/flu symptoms. CLINICAL IMPLICATIONS: PEx-related symptoms in patients with bronchiectasis remain elevated for several weeks after peak PEx event, contributing to disease burden."

Clinical • Retrospective data • Bronchiectasis • Chronic Cough • Cough • Fatigue • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

THE EFFECT OF BRENSOCATIB VS PLACEBO ON SYMPTOM BURDEN IN PATIENTS WITH OR WITHOUT ON-STUDY PULMONARY EXACERBATIONS: A POSTHOC ANALYSIS FROM THE ASPEN TRIAL (CHEST 2025) - P3 | "Brensocatib 10mg and 25mg reduced symptom burden, regardless of PEx occurrence; the reductions were greatest in patients on 25mg and those without on-study PEx. Both brensocatib doses also reduced the symptom burden vs placebo during severe PEx events. CLINICAL IMPLICATIONS: Patient-reported symptom burden was lowest in patients without PEx and improved with doses of brensocatib regardless of PEx occurrence or severity, highlighting the importance of PEx prevention."

Clinical • Retrospective data • Bronchiectasis • Chronic Cough • Cough • Fatigue • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Recent Investigations in Pharmacotherapy for Bronchiectasis. (PubMed, Am J Respir Crit Care Med) - No abstract available

Journal • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Efficacy of Brensocatib in Patients with Eosinophilic Inflammation in Bronchiectasis: An Analysis of the ASPEN Trial (WBC 2025) - P3 | "Consistent with the overall study population, both brensocatib doses reduced the annualized rate of exacerbations, and brensocatib 25-mg also reduced lung function decline and nominally improved patient-reported outcomes regardless of high or low blood eosinophil counts at baseline."

Clinical • Bronchiectasis • Eosinophilia • Genetic Disorders • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

Lung Function in Patients With Non-Cystic Fibrosis Bronchiectasis By Prespecified Subgroups in the Phase 3, Randomized, Double-Blind, Placebo-Controlled Aspen Trial (WBC 2025) - P3 | "Consistent with the results of the overall ASPEN trial population, brensocatib 25-mg reduced FEV 1 decline vs placebo for all subgroups analyzed. These results demonstrate that brensocatib has a positive impact on post-bronchodilator FEV 1 across all subgroups evaluated, an important observation in a heterogeneous disease like bronchiectasis. Previously presented at CHEST 2024."

Clinical • P3 data • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Cough • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Profiling DPP-1 signalling networks underlying lung immune defence (WBC 2025) - "We identified that 30 mg/kg/day brensocatib significantly reduced DPP1 activity, along with a corresponding reduction in elastase activity in the murine lung. This establishment of DPP1 inhibition in brensocatib-treated vs drug vehicle-treated groups will enable us to proceed with enrichment-free N-terminomics to identify changes in global protein abundance and proteolytic cleavages mediated by DPP1."

Inflammation • Pulmonary Disease • Respiratory Diseases • CTSB • CTSK • ELANE • LGMN

Brensocatib Reduced Bronchiectasis Exacerbations, Improved Symptoms in Asian Patients (Respiratory Therapy) - "Brensocatib reduced the annualized exacerbation rate (rate ratio [95% CI] 10mg: 0.40 [0.23-0.67]; 25mg: 0.41 [0.24-0.70]), prolonged time to first exacerbation (hazard ratio [95% CI] 10mg: 0.45 [0.26-0.77], 25mg: 0.47 [0.27-0.82]), and increased the odds of remaining exacerbation-free (odds ratio [95% CI] 10mg: 3.29 [1.46-7.40]; 25mg: 3.19 [1.43-7.13]) vs placebo. Brensocatib reduced FEV1 decline (week 52 least squares mean (LSmean) difference in mL vs placebo [95% CI] 10mg: 18 [-27-63]; 25mg: 69 [24-114])....Further results will be shared at the CHEST Annual Meeting 2025..."

P3 data • Non‐Cystic Fibrosis Bronchiectasis