Non-Cystic Fibrosis Bronchiectasis Pipeline Insight 2025: FDA Approves BRINSUPRI and Emerging Targeted Therapies Transform Disease Management | DelveInsight

In August 2025, the FDA approved Insmed's BRINSUPRI, the first oral therapy for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older, marking a landmark development for a chronic lung condition historically lacking targeted treatments.

DelveInsight's "Non-Cystic Fibrosis Bronchiectasis - Pipeline Insight, 2025" provides a detailed analysis of the evolving therapeutic landscape for NCFB, a progressive respiratory disorder characterized by chronic airway inflammation, recurrent infections, and a gradual decline in lung function. Frequent exacerbations significantly impact patient quality of life, creating an urgent need for disease-modifying interventions.

The 2025 pipeline highlights the emergence of targeted anti-inflammatory therapies, neutrophil-modulating agents, and novel biologics. BRINSUPRI, a first-in-class dipeptidyl peptidase I (DPP1) inhibitor, reduces neutrophilic inflammation, demonstrating in pivotal trials (ASPEN and WILLOW) a reduction in annualized exacerbation rates and slowed lung function decline. Beyond BRINSUPRI, inhaled antibiotics, macrolide-based regimens, and emerging biologics are being investigated to improve long-term outcomes and minimize steroid dependence.

Clinical trials increasingly incorporate patient-reported outcomes, exacerbation frequency, and biomarker-based endpoints to better capture efficacy and long-term benefit. The regulatory landscape is evolving, with orphan drug designations and breakthrough therapy statuses accelerating development timelines.

With a robust pipeline of oral, inhaled, and biologic agents, NCFB management is moving toward personalized, targeted therapies that address the underlying inflammatory mechanisms, offering hope for improved disease control and enhanced patient quality of life.

Interested in learning more about the current treatment landscape and the key drivers shaping the non-cystic fibrosis bronchiectasis pipeline? Click here: https://www.delveinsight.com/report-store/non-cystic-fibrosis-bronchiectasis-ncfb-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Non-Cystic Fibrosis Bronchiectasis Pipeline Report
• DelveInsight's non-cystic fibrosis bronchiectasis pipeline analysis depicts a strong space with 15+ active players working to develop 15+ pipeline drugs for non-cystic fibrosis bronchiectasis treatment.
• The leading non-cystic fibrosis bronchiectasis companies include Zambon SpA, AstraZeneca, Insmed Incorporated, NovaBiotics, Haisco Pharmaceutical Group, Armata Pharmaceuticals, Chiesi Farmaceutici, CSL Behring, and others are evaluating their lead assets to improve the non-cystic fibrosis bronchiectasis treatment landscape.
• Key non-cystic fibrosis bronchiectasis pipeline therapies in various stages of development include Colistimethate sodium, Benralizumab, HSK31858, CHF 6333, CSL 787, AP-PA02, ARINA-1, and others.
• In August 2025, the FDA approved Insmed's BRINSUPRI (brensocatib), the first oral therapy for non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older.
• In Feb 2025, Insmed Incorporated announced that the FDA informed the company it does not plan to hold an advisory committee meeting to discuss the New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis.
• In February 2025, Insmed Incorporated announced that the FDA has accepted its New Drug Application (NDA) for brensocatib, intended for patients with non-cystic fibrosis bronchiectasis. The FDA granted Priority Review and set a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA).

Request a sample and discover the recent breakthroughs happening in the non-cystic fibrosis bronchiectasis pipeline landscape at https://www.delveinsight.com/report-store/non-cystic-fibrosis-bronchiectasis-ncfb-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Non-Cystic Fibrosis Bronchiectasis Overview
Non-Cystic Fibrosis Bronchiectasis (NCFB) is a chronic lung condition characterized by abnormal widening of the bronchi, leading to mucus buildup, recurrent infections, and inflammation. Unlike cystic fibrosis-related bronchiectasis, NCFB arises from various causes such as past infections, autoimmune diseases, or airway blockages. Patients often experience persistent cough, sputum production, and frequent respiratory infections. Over time, the condition can lead to lung damage and reduced quality of life. Management focuses on airway clearance, treating infections, and controlling inflammation to prevent disease progression and improve symptoms.

Find out more about non-cystic fibrosis bronchiectasis medication at https://www.delveinsight.com/report-store/non-cystic-fibrosis-bronchiectasis-ncfb-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Non-Cystic Fibrosis Bronchiectasis Treatment Analysis: Drug Profile
HSK31858: Haisco Pharmaceutical Group Co., Ltd.
HSK31858 is an oral, highly selective dipeptidyl peptidase 1 (DPP1) inhibitor developed by Haisco Pharmaceutical. By targeting DPP1, it suppresses neutrophil activation and reduces the release of neutrophil serine proteases (NSPs) into circulation. This mechanism is aimed at treating lower respiratory tract diseases, including bronchiectasis and acute lung injury/ARDS. Phase I trials have been completed in both Australia and China, and Phase II trials are currently underway, with the first patient already dosed and the study progressing as planned.

CSL 787: CSL Behring
CSL 787 is a human plasma-derived immunoglobulin designed for inhalation via nebulizer, intended to help prevent chronic respiratory infections and slow disease progression in conditions like Non-Cystic Fibrosis Bronchiectasis (NCFB). The therapy is currently in Phase I clinical development for NCFB.

Learn more about the novel and emerging non-cystic fibrosis bronchiectasis pipeline therapies at https://www.delveinsight.com/report-store/non-cystic-fibrosis-bronchiectasis-ncfb-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Non-Cystic Fibrosis Bronchiectasis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Non-Cystic Fibrosis Bronchiectasis Pipeline Report
• Coverage: Global
• Key Non-Cystic Fibrosis Bronchiectasis Companies: Zambon SpA, AstraZeneca, Insmed Incorporated, NovaBiotics, Haisco Pharmaceutical Group, Armata Pharmaceuticals, Chiesi Farmaceutici, CSL Behring, and others.
• Key Non-Cystic Fibrosis Bronchiectasis Pipeline Therapies: Colistimethate sodium, Benralizumab, HSK31858, CHF 6333, CSL 787, AP-PA02, ARINA-1, and others.

To dive deep into rich insights for drugs used for non-cystic fibrosis bronchiectasis treatment, visit: https://www.delveinsight.com/report-store/non-cystic-fibrosis-bronchiectasis-ncfb-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Non-Cystic Fibrosis Bronchiectasis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Non-Cystic Fibrosis Bronchiectasis Pipeline Therapeutics
6. Non-Cystic Fibrosis Bronchiectasis Pipeline: Late-Stage Products (Phase III)
7. Non-Cystic Fibrosis Bronchiectasis Pipeline: Mid-Stage Products (Phase II)
8. Non-Cystic Fibrosis Bronchiectasis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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This release was published on openPR.