Brinsupri (brensocatib) / Insmed, AstraZeneca - LARVOL DELTA

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis (clinicaltrials.gov) - P2 | N=29 | Completed | Sponsor: Insmed Incorporated | Phase classification: P2a ➔ P2

Phase classification • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) – The BiRCh Study (AAAAI 2026) - P2 | "Patients underwent a screening period of up to 5 weeks to determine eligibility, during which all patients were treated with daily mometasone furoate nasal spray (MFNS). Results Primary, key secondary, and safety results will be reported. Conclusions Brensocatib is being evaluated as a potential new therapy for CRSsNP, a neutrophil-mediated disease."

Clinical • P2b data • Asthma • Bronchiectasis • Genetic Disorders • Immunology • Inflammation • Nasal Polyps • Non‐Cystic Fibrosis Bronchiectasis • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis

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 | Trial primary completion date: May 2026 ➔ Feb 2026

Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

Cystic fibrosis year in review 2025. (PubMed, J Cyst Fibros) - "First, we discuss the consolidation of elexacaftor/tezacaftor/ivacaftor (ETI) and next-generation modulators, highlighting durable gains in lung function and survival alongside persistent gaps in eligibility, access, and long-term safety, particularly for individuals with advanced structural lung damage or class I variants. Second, emerging mutation-agnostic therapy strategies are outlined, including ENaC blockade, neutrophil-directed anti-inflammatories like brensocatib, and gene and nucleic acid-based therapeutic approaches...Finally, as survival improves, pregnancy, age-related malignancy, and cardiovascular disease are becoming increasingly relevant, necessitating new models of multidisciplinary, lifespan care. Collectively, these developments mark a shift towards equitable, lifelong, system-level management of health in an aging and increasingly diverse CF population."

Journal • Review • Cardiovascular • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases

Exposure-response Relationships of Brensocatib in Adult and Adolescent Patients With Non-Cystic Fibrosis Bronchiectasis (ATS 2026) - No abstract available

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

Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review. (PubMed, Br J Pharmacol) - "Among the FIC drugs, it is worth mentioning the Nav1.8 channel inhibitor suzetrigine, the first non-opioid approved to palliate acute pain; the first positive allosteric modulator of transient receptor potential melastatin 8 (TRPM8), acoltremon, that increases basal tear production in dry eye disease, a globally common disorder; lerodalcibep, a 'third generation' adnectin inhibitor of the protease Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) to treat elevated LDL-c; and zoliflodacin and gepotidacin, both innovatively targeting bacterial topoisomerases to treat uncomplicated urinary tract infections. These approaches include: the combination of two FIC drugs, the RAF/MEK clamp avutometinib paired with the FAK/Pyk2 inhibitor defactinib, to block more efficiently the RAS-RAF-MEK-ERK/FAK oncogenic pathway in low-grade serous ovarian cancer; fitusiran, the first RNAi therapy for haemophilia, targeting for the first time the production of the natural..."

European regulatory • FDA event • Journal • Review • Bronchiectasis • Dry Eye Disease • Hematological Disorders • Hemophilia • Infectious Disease • Nephrology • Oncology • Ophthalmology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Solid Tumor • NAV1 • TRPM8

A Case Report of Long-Term Use of Brensocatib (ATS 2026) - No abstract available

Case report • Clinical • Bronchiectasis • Cough • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Effect of Brensocatib on Patient-Reported Symptoms in Patients With Non-Cystic Fibrosis Bronchiectasis: A Post Hoc Analysis of QOL-B RSS Individual Items From the ASPEN Phase 3 Trial (ATS 2026) - No abstract available

Clinical • P3 data • Retrospective data • Bronchiectasis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

The effectiveness and value of brensocatib for the treatment of non-cystic fibrosis bronchiectasis. (PubMed, J Manag Care Spec Pharm) - No abstract available

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

Targeting Neutrophil Function as Therapy for Hidradenitis Suppurativa. (PubMed, Int J Mol Sci) - "Strategies advancing through clinical trials include inhibition of chemokine-mediated trafficking, neutrophil serine protease inactivation and suppression of neutrophil extracellular traps (NETs), which amplify inflammatory and autoimmune responses. These emerging therapies mark a significant shift toward targeted neutrophil modulation, offering new opportunities to improve outcomes for patients with HS."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Pain • IL17A • TNFA

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for the medicine brensocatib (Brinsupri) to treat patients 12 years and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more flare-ups or worsening of symptoms in the past 12 months. (GOV.UK)

MHRA approval • Non‐Cystic Fibrosis Bronchiectasis

Progress and Anticipated Milestones by Therapeutic Area: Respiratory: BRINSUPRI (PRNewswire) - "Insmed anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion....Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom (UK) and Japan in 2026."

Japan approval • MHRA approval • Sales projection • Non‐Cystic Fibrosis Bronchiectasis

Progress and Anticipated Milestones:…Brensocatib (PRNewswire) - "In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026."

Enrollment closed • P2b data • Hidradenitis Suppurativa

Clearing the air: Clarifying data and interpretations from the ASPEN trial of brensocatib in bronchiectasis. (PubMed, Med) - No abstract available

Journal • Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Brensocatib-Another Therapeutic "Window of Opportunity" for Patients with Bronchiectasis. (PubMed, J Clin Med) - " As the first FDA-approved (12 August 2025) mechanism-based therapy for non-cystic fibrosis bronchiectasis, brensocatib represents a paradigm shift toward targeted, precision treatment of neutrophil-mediated airway disease. Its clinical efficacy, biomarker-driven rationale, and potential to reduce antibiotic dependence highlight brensocatib as a cornerstone therapy in bronchiectasis management and a promising strategy for other neutrophil-driven inflammatory conditions."

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

Brensocatib (Brinsupri) first FDA-approved targeted therapy for 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

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