Brinsupri (brensocatib) / Insmed, AstraZeneca - LARVOL DELTA

The convergent pathway of obstructive lung disease: the disease-modifying potential of dipeptidyl peptidase 1 inhibition in COPD, asthma and bronchiectasis overlap. (PubMed, Drugs Context) - "Brensocatib, a first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), offers a novel, targeted strategy...These findings validate DPP1 inhibition as a first potential disease-modifying therapy. This strategy is poised to fundamentally shift clinical focus from symptom control to the preservation of lung function for patients with severe, neutrophilic-driven neutrophilic overlap syndromes."

Journal • Review • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • ELANE

Anti-inflammatory therapies for bronchiectasis. (PubMed, Curr Opin Infect Dis) - "Anti-inflammatory therapy is one of the integral components of treatment for people with bronchiectasis."

Journal • Allergic Bronchopulmonary Aspergillosis • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • ELANE

New Perspectives in the Treatment of Bronchiectasis. (PubMed, Arch Bronconeumol) - "Despite recent approval of Brensocatib, current management relies mostly on off-label therapies, highlighting the need for evidence-based strategies...Mapping the current landscape of randomized clinical trials (RCTs) highlights the efforts to improve patient outcomes and translate mechanistic insights into clinical practice. This review underscores the shift toward individualized, mechanism-based therapy in bronchiectasis management providing a comprehensive overview of current and emerging therapeutic approaches in bronchiectasis, focusing on ongoing and recent RCTs."

Clinical • Journal • Review • Bronchiectasis • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics and Safety of a Single Dose of Brensocatib in Participants with Hepatic Impairment and Matched Participants with Normal Hepatic Functions. (PubMed, Clin Pharmacokinet) - P1 | "No new safety signals were identified in participants with or without hepatic impairment treated with a single dose of 25 mg brensocatib. The oral absorption and elimination of brensocatib were not significantly altered in participants with mild, moderate, or severe hepatic impairment, suggesting that dose adjustment for brensocatib treatment in patients with hepatic impairment is not necessary."

Journal • PK/PD data • Breast Cancer • Hepatology • Oncology • Solid Tumor

Pneumology : what's new in 2025 (PubMed, Rev Med Suisse) - "The PREDMETH study compared methotrexate and prednisone, demonstrating similar efficacy on lung function at 24 weeks. Non-cystic fibrosis bronchiectasis (NCFBE) has long been limited to repeating what works in cystic fibrosis patients, such as supportive treatments, inhaled antibiotics and macrolides. The first phase 3 trial for a treatment targeting specifically neutrophil inflammation: brensocatib, is presented in this article."

Journal • Bronchiectasis • Cystic Fibrosis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • Sarcoidosis

Brinsupri: “Demonstrates continued strength in first full quarter of revenue; Cumulative prescribers ~4,000 up from ~1,700 prescribers as of 9/30/2025“ (44th Annual J.P. Morgan Healthcare Conference, Insmed, Inc)

Commercial • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

Brinsupri: “Demonstrates continued strength in first full quarter of revenue; Cumulative prescribers ~4,000 up from ~1,700 prescribers as of 9/30/2025“ (44th Annual J.P. Morgan Healthcare Conference, Insmed, Inc)

Commercial • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial. (PubMed, Respir Investig) - P3 | "Consistent with overall ASPEN results, brensocatib 10 mg and 25 mg reduced exacerbation frequency vs placebo in Japanese patients with bronchiectasis. Lung function, patient-reported symptoms, and safety data were consistent with overall ASPEN trial results."

Journal • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Pneumonia • Pulmonary Disease • Respiratory Diseases

Primary Humoral Immunodeficiencies and Bronchiectasis in Adults. (PubMed, J Clin Med) - "Identifying immunoglobulin defects is clinically important because they represent treatable traits. The potential role of emerging therapies such as the DPP1 inhibitor brensocatib in immunodeficiency-related bronchiectasis remains uncertain, and ongoing registries will be key to clarifying these relationships."

Journal • Review • Bronchiectasis • Immunology • Infectious Disease • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases

Insmed Provides Clinical…Update (PRNewswire) - "Insmed Incorporated...announced today that the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms....Insmed has discontinued its development program of brensocatib in CRSsNP effective immediately and intends to present these data at a future congress....In the study, a negative score in the primary endpoint of change from baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS) at Week 24 indicated an improvement. Topline results from each treatment arm were as follows: placebo least squares (LS) mean was -2.44; brensocatib 10 mg LS mean was -2.21; and brensocatib 40 mg LS mean was -2.33."

Discontinued • P2b data • Immunology • Inflammation

Insmed also announced timeline updates for key clinical trials… (Investing.com) - "...results from the Phase 2b CEDAR study of brensocatib in hidradenitis suppurativa expected in the second quarter of 2026....The company initiated its Phase 3 PALM-ILD study of TPIP in pulmonary hypertension associated with interstitial lung disease in the fourth quarter of 2025, with additional Phase 3 studies planned for 2026."

New P3 trial • P2b data • Trial status • Hidradenitis Suppurativa • Immunology • Interstitial Lung Disease • Pulmonary Disease

Insmed stock rises after strong BRINSUPRI launch, ARIKAYCE revenue beat (Investing.com) - "The biopharmaceutical company reported unaudited BRINSUPRI (brensocatib) revenue of approximately $144.6 million for its first full quarter on the market, with full-year 2025 sales reaching approximately $172.7 million. ARIKAYCE (amikacin liposome inhalation suspension) exceeded the company’s guidance range with unaudited global revenues of approximately $433.8 million for 2025, representing 19% YoY growth."

Sales • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis

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

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

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