“Severe Asthma Pipeline Insight, 2026" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Severe Asthma Market.
The Severe Asthma 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.
Some of the key takeaways from the Severe Asthma Pipeline Report:
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Companies across the globe are diligently working toward developing novel Severe Asthma treatment therapies with a considerable amount of success over the years.
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Severe Asthma companies working in the treatment market are Lanier Biotherapeutics, Bio-Thera Solutions, Kinaset Therapeutics, CSPC ZhongQi Pharmaceutical Technology, Oneness Biotech Co., Ltd., Chia Tai Tianqing Pharmaceutical Group, AB Science, GlaxoSmithKline, and others, are developing therapies for the Severe Asthma treatment
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Emerging Severe Asthma therapies in the different phases of clinical trials are- LNR 125.38, BAT2606, KN-002, CM326, FB 704A, TQC2731, Masitinib, GSK3511294, and others are expected to have a significant impact on the Severe Asthma market in the coming years.
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In December 2025, According to GlaxoSmithKline, the US FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Exdensur is the first ultra-long-acting biologic being studied for respiratory conditions driven by type 2 inflammation, including severe asthma. The therapy has been designed with an extended half-life, allowing for twice-yearly dosing.
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In December 2025, GSK plc (LSE/NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in adults and pediatric patients aged 12 years and older. The approval is supported by results from the Phase III SWIFT-1 and SWIFT-2 trials, in which depemokimab achieved sustained reductions in asthma exacerbations with twice-yearly dosing compared with placebo, when added to standard of care.
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In July 2025, Asthma severity is influenced by numerous inflammatory pathways, making a “one-size-fits-all” treatment approach difficult. This has led researchers to explore precision medicine for asthma, which involves identifying disease subtypes through specific biological markers (biomarkers) and tailoring treatments accordingly. “By conducting a trial that leverages precision medicine to guide patients toward the treatment most suited to their individual profile, we aim to apply a strategy that has shown success in cancer studies. This approach, known as a platform trial, evaluates multiple interventions simultaneously in enrolled participants.”
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In May 2025, New Phase 3 WAYFINDER results, presented at ATS 2025, indicate that treatment with tezepelumab (Tezspire) can significantly reduce or even eliminate oral corticosteroid (OCS) use in adults with OCS-dependent severe asthma. Steroid dependence is prevalent and a critical issue in severe asthma, as long-term OCS use can cause adverse effects, including bone, cardiovascular, metabolic, gastrointestinal, and psychiatric complications, as well as adrenal insufficiency.
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In May 2025, Connect Biopharma, a US biopharmaceutical company, has initiated a Phase II trial to evaluate the safety and effectiveness of rademikibart for acute asthma exacerbations and type II inflammation. The Seabreeze STAT Asthma trial plans to enroll approximately 160 patients globally experiencing acute asthma flare-ups. Participants will receive a single subcutaneous dose of either rademikibart or a placebo.
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In March 2025, Connect Biopharma Holdings Limited (Nasdaq: CNTB), a clinical-stage biopharmaceutical company focused on advancing care for asthma and Chronic Obstructive Pulmonary Disease (COPD), has announced the online publication of encouraging data from its global Phase 2 study of rademikibart. Published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), the results underscore rademikibart’s promise as an innovative biologic therapy for patients with moderate-to-severe uncontrolled asthma linked to Type 2 inflammation. The findings revealed a rapid onset of action, consistent improvements in lung function (FEV1), and meaningful reductions in annual asthma exacerbations.
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In October 2024, AstraZeneca announced positive top-line results from the BATURA Phase IIIb trial, revealing that AIRSUPRA® (albuterol/budesonide) achieved its primary goal. The treatment significantly and meaningfully reduced the risk of severe asthma exacerbations when used as an as-needed rescue therapy, compared to albuterol alone. The study involved patients with intermittent or mild persistent asthma, including those receiving only short-acting beta2-agonists (SABA), low-dose inhaled corticosteroids (ICS), or leukotriene receptor antagonist (LTRA) maintenance therapies.
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In September 2024, Kinaset Therapeutics presented two oral sessions and a late-breaking poster at the 2024 European Respiratory Society (ERS) Congress. The presentations highlighted the potential of its lead clinical candidate, frevecitinib (KN-002), as a treatment for all patients with moderate to severe asthma and those with COPD.
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In May 2024, GSK reported positive topline results from the Phase III SWIFT-1 and SWIFT-2 trials, evaluating the efficacy and safety of depemokimab compared to placebo in adults and adolescents with severe asthma associated with type 2 inflammation, as indicated by blood eosinophil levels
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In April 2024, A total of 25 abstracts covering both approved and investigational medicines will be presented at this year’s American Thoracic Society (ATS) International Conference. Key highlights from Sanofi’s immunology pipeline include the first presentation of Phase IIb data on rilzabrutinib for moderate to severe asthma.
Severe Asthma Overview
Severe asthma is a chronic respiratory condition characterized by persistent, difficult-to-control symptoms despite high-dose medications such as inhaled corticosteroids and bronchodilators. Individuals with severe asthma experience frequent symptoms like shortness of breath, wheezing, coughing, and tightness in the chest, and they are prone to severe asthma attacks that require medical intervention. Severe asthma can be triggered by allergens, respiratory infections, and environmental factors, and often requires more intensive treatments, including biologic therapies or oral corticosteroids, to manage symptoms and improve quality of life.
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Emerging Severe Asthma Drugs Under Different Phases of Clinical Development Include:
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LNR 125.38: Lanier Biotherapeutics
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BAT2606: Bio-Thera Solutions
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KN-002: Kinaset Therapeutics
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CM326: CSPC ZhongQi Pharmaceutical Technology
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FB 704A: Oneness Biotech Co., Ltd.
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TQC2731: Chia Tai Tianqing Pharmaceutical Group
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Masitinib: AB Science
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GSK3511294: GlaxoSmithKline
Severe Asthma Pipeline Therapeutics Assessment
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Severe Asthma Assessment by Product Type
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Severe Asthma By Stage and Product Type
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Severe Asthma Assessment by Route of Administration
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Severe Asthma By Stage and Route of Administration
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Severe Asthma Assessment by Molecule Type
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Severe Asthma by Stage and Molecule Type
DelveInsight's Severe Asthma Report covers around 50+ products under different phases of clinical development like
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Late-stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I)
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
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Route of Administration
Further Severe Asthma product details are provided in the report. Download the Severe Asthma pipeline report to learn more about the emerging Severe Asthma therapies
Some of the key companies in the Severe Asthma Therapeutics Market include:
Key companies developing therapies for Severe Asthma are - Genentech, Inc., GlaxoSmithKline, Kymab, Sanofi, 4D Pharma plc, AstraZeneca, Sinomab, Avalo Therapeutics, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Cumberland Pharmaceuticals, and others.
Severe Asthma Pipeline Analysis:
The Severe Asthma pipeline report provides insights into
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The report provides detailed insights about companies that are developing therapies for the treatment of Severe Asthma with aggregate therapies developed by each company for the same.
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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Severe Asthma Treatment.
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Severe Asthma key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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Severe Asthma 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.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Severe Asthma 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 Severe Asthma drugs and therapies
Severe Asthma Pipeline Market Drivers
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Increase in the prevalence of Severe Asthma, development of new and innovative treatment options for severe asthma are some of the important factors that are fueling the Severe Asthma Market.
Severe Asthma Pipeline Market Barriers
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However, high cost of asthma medications, poor adherence to treatment, limited efficacy of existing treatments and other factors are creating obstacles in the Severe Asthma Market growth.
Scope of Severe Asthma Pipeline Drug Insight
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Coverage: Global
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Key Severe Asthma Companies: Lanier Biotherapeutics, Bio-Thera Solutions, Kinaset Therapeutics, CSPC ZhongQi Pharmaceutical Technology, Oneness Biotech Co., Ltd., Chia Tai Tianqing Pharmaceutical Group, AB Science, GlaxoSmithKline, and others
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Key Severe Asthma Therapies: LNR 125.38, BAT2606, KN-002, CM326, FB 704A, TQC2731, Masitinib, GSK3511294, and others
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Severe Asthma Therapeutic Assessment: Severe Asthma current marketed and Severe Asthma emerging therapies
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Severe Asthma Market Dynamics: Severe Asthma market drivers and Severe Asthma market barriers
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Table of Contents
1. Severe Asthma Report Introduction
2. Severe Asthma Executive Summary
3. Severe Asthma Overview
4. Severe Asthma- Analytical Perspective In-depth Commercial Assessment
5. Severe Asthma Pipeline Therapeutics
6. Severe Asthma Late Stage Products (Phase II/III)
7. Severe Asthma Mid Stage Products (Phase II)
8. Severe Asthma Early Stage Products (Phase I)
9. Severe Asthma Preclinical Stage Products
10. Severe Asthma Therapeutics Assessment
11. Severe Asthma Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Severe Asthma Key Companies
14. Severe Asthma Key Products
15. Severe Asthma Unmet Needs
16 . Severe Asthma Market Drivers and Barriers
17. Severe Asthma Future Perspectives and Conclusion
18. Severe Asthma 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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