Cystic Fibrosis Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, And FDA Approvals By Delveinsight Insmed Inc, Astrazeneca, Zambon, CSL Behring, Chiesi Farmaceutici

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(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Cystic Fibrosis pipeline constitutes 50+ key companies continuously working towards developing 55+ Cystic Fibrosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Cystic Fibrosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

“Cystic Fibrosis Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Cystic Fibrosis Market.

Some of the key takeaways from the Cystic Fibrosis Pipeline Report:

• Companies across the globe are diligently working toward developing novel Cystic Fibrosis treatment therapies with a considerable amount of success over the years.

• Cystic Fibrosis companies working in the treatment market are NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others, are developing therapies for the Cystic Fibrosis treatment

• Emerging Cystic Fibrosis therapies in the different phases of clinical trials are- NP339, Research Programme:NCFB, Research programme: mucolytic agents, CHF 6333, CSL787, HSK31858, S-1226, Benralizumab, Colistimethate sodium, BI 1291583, AP-PA02, ARINA-1, and others are expected to have a significant impact on the Cystic Fibrosis market in the coming years.

• In August 2025, The FDA has approved brensocatib (Brinsupri; Insmed) for treating non–cystic fibrosis bronchiectasis, making it the first therapy approved for this patient population and the first dipeptidyl peptidase 1 (DPP1) inhibitor authorized for a neutrophil-mediated disease. Brensocatib is an oral, small-molecule, reversible DPP1 inhibitor that works by blocking DPP1, thereby reducing the activation of neutrophil serine proteases-key contributors to inflammation and tissue damage in chronic lung conditions like bronchiectasis.

• In July 2025, BiomX enrolled the first participant in the randomized Phase IIb study of its fixed multi-phage therapy, BX004, for the treatment of cystic fibrosis (CF). The trial targets CF patients suffering from chronic lung infections caused by Pseudomonas aeruginosa (P. aeruginosa). Topline results are expected in the first quarter of 2026, positioning BX004 as a potential phage-based therapy for these serious, life-threatening infections.

• In February 2025, Boehringer Ingelheim initiated a Phase 1/2 clinical trial of BI 3720931, an inhaled gene therapy for cystic fibrosis (CF). The first-in-human study, named LENTICLAIR 1 (NCT06515002), plans to enroll approximately 36 adults with CF who are ineligible for CFTR modulator therapy. In Phase 1, participants will receive one of three escalating doses of BI 3720931, primarily to evaluate safety. In Phase 2, patients will receive either one of two therapy doses or a placebo, with the main objective of assessing the treatment's impact on lung function markers over roughly two months.

• In January 2025, Recode Therapeutics dosed the first U.S. patient in a Phase 1b trial evaluating the safety of RCT2100, its inhaled therapy for cystic fibrosis (CF). The study, which is already ongoing in Europe, targets patients who are ineligible for or unresponsive to CFTR modulator therapies-representing roughly 10% of the CF population. CFTR modulators are typically used to treat CF caused by specific genetic mutations. The first U.S. participant (NCT06237335) received the therapy at New York Medical College (NYMC).

Cystic Fibrosis Overview

Cystic Fibrosis is a genetic disorder that affects the lungs, digestive system, and other organs. It is caused by mutations in the CFTR gene, leading to the production of thick, sticky mucus that clogs airways and ducts. This results in breathing problems, frequent lung infections, poor nutrient absorption, and digestive issues. CF is a chronic, progressive condition, but advances in therapies have improved life expectancy and quality of life for patients.

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Emerging Cystic Fibrosis Drugs Under Different Phases of Clinical Development Include:

• NP339: NovaBiotics Ltd

• Research Programme:NCFB: Synspira Therapeutics

• Research programme: mucolytic agents: Parion Sciences

• CHF 6333 : Chiesi Farmaceutic

• CSL787 : CSL Behring

• HSK31858: Haisco Pharmaceutical

• S-1226: SolAeroMed Inc.

• Benralizumab: AstraZeneca

• Colistimethate sodium : Zambon SpA

• BI 129158 3: Boehringer Ingelheim

• AP-PA02 : Armata Pharmaceuticals

• ARINA-1: Renovion

Cystic Fibrosis Route of Administration

Cystic Fibrosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Intravenous

• Subcutaneous

• Oral

• Intramuscular

Cystic Fibrosis Molecule Type

Cystic Fibrosis Products have been categorized under various Molecule types, such as

• Monoclonal antibody

• Small molecule

• Peptide

Cystic Fibrosis Pipeline Therapeutics Assessment

• Cystic Fibrosis Assessment by Product Type

• Cystic Fibrosis By Stage and Product Type

• Cystic Fibrosis Assessment by Route of Administration

• Cystic Fibrosis By Stage and Route of Administration

• Cystic Fibrosis Assessment by Molecule Type

• Cystic Fibrosis by Stage and Molecule Type

DelveInsight's Cystic Fibrosis Report covers around 55+ products under different phases of clinical development like

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Cystic Fibrosis product details are provided in the report. Download the Cystic Fibrosis pipeline report to learn more about the emerging Cystic Fibrosis therapies

Some of the key companies in the Cystic Fibrosis Therapeutics Market include:

Key companies developing therapies for Cystic Fibrosis are - Insmed Incorporated, AstraZeneca, Zambon, CSL Behring, Chiesi Farmaceutici, Haisco Pharmaceutical, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, SolAeroMed, and others.

Cystic Fibrosis Pipeline Analysis:

The Cystic Fibrosis pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Cystic Fibrosis with aggregate therapies developed by each company for the same.

• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Cystic Fibrosis Treatment.

• Cystic Fibrosis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Cystic Fibrosis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Cystic Fibrosis market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Cystic Fibrosis drugs and therapies

Cystic Fibrosis Pipeline Market Drivers

• Recent Developments to Improve Research into Bronchiectasis, emergence of Novel Drugs & Therapies with Great Market Potential are some of the important factors that are fueling the Cystic Fibrosis Market.

Cystic Fibrosis Pipeline Market Barriers

• However, challenges Associated with the Drug Delivery, regulatory & Economic Hindrance and other factors are creating obstacles in the Cystic Fibrosis Market growth.

Scope of Cystic Fibrosis Pipeline Drug Insight

• Coverage: Global

• Key Cystic Fibrosis Companies: NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others

• Key Cystic Fibrosis Therapies: NP339, Research Programme:NCFB, Research programme: mucolytic agents, CHF 6333, CSL787, HSK31858, S-1226, Benralizumab, Colistimethate sodium, BI 1291583, AP-PA02, ARINA-1, and others

• Cystic Fibrosis Therapeutic Assessment: Cystic Fibrosis current marketed and Cystic Fibrosis emerging therapies

• Cystic Fibrosis Market Dynamics: Cystic Fibrosis market drivers and Cystic Fibrosis market barriers

Request for Sample PDF Report for Cystic Fibrosis Pipeline Assessment and clinical trials

Table of Contents

1. Cystic Fibrosis Report Introduction

2. Cystic Fibrosis Executive Summary

3. Cystic Fibrosis Overview

4. Cystic Fibrosis- Analytical Perspective In-depth Commercial Assessment

5. Cystic Fibrosis Pipeline Therapeutics

6. Cystic Fibrosis Late Stage Products (Phase II/III)

7. Cystic Fibrosis Mid Stage Products (Phase II)

8. Cystic Fibrosis Early Stage Products (Phase I)

9. Cystic Fibrosis Preclinical Stage Products

10. Cystic Fibrosis Therapeutics Assessment

11. Cystic Fibrosis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Cystic Fibrosis Key Companies

14. Cystic Fibrosis Key Products

15. Cystic Fibrosis Unmet Needs

16 . Cystic Fibrosis Market Drivers and Barriers

17. Cystic Fibrosis Future Perspectives and Conclusion

18. Cystic Fibrosis Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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