Friday, March 20, 2026

Asthma Pipeline 2026: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Lanier Biotherapeutics, Bio-Thera Solutions, Kinaset Therapeutics, CSPC ZhongQi Pharma

Asthma Pipeline 2026: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Lanier Biotherapeutics, Bio-Thera Solutions, Kinaset Therapeutics, CSPC ZhongQi Pharma
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Asthma pipeline constitutes 80+ key companies continuously working towards developing 90+ Asthma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

Asthma Pipeline Insight, 2026" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Asthma Market.

 

The 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 Asthma Pipeline Report:

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

  • Asthma companies working in the treatment market are Sanofi, Regeneron Pharmaceuticals, Amgen, Areteia Therapeutic, GlaxoSmithKline, Lanier Biotherapeutics, Bio-Thera Solutions, Kinaset Therapeutics, CSPC ZhongQi Pharmaceutical Technology, Oneness Biotech Co., Ltd., Chia Tai Tianqing Pharmaceutical Group, AB Science, and others, are developing therapies for the Asthma treatment

  • Emerging Asthma therapies in the different phases of clinical trials are- DUPIXENT (dupilumab), TEZSPIRE (tezepelumab), FASENRA (benralizumab), Dexpramipexole, Depemokimab (GSK3511294), BREZTRI AEROSPHERE (BGF; PT-010), LNR 125.38, BAT2606, KN-002, CM326, FB 704A, TQC2731, Masitinib, GSK3511294, and others are expected to have a significant impact on the Asthma market in the coming years.

  • In March 2026, The US FDA has approved the first generic version of Flovent HFA (fluticasone propionate) inhalation aerosol, delivering 44 micrograms per actuation, for the preventive maintenance treatment of asthma in patients aged 4 years and older. Flovent HFA is an inhaled corticosteroid that helps manage asthma by reducing inflammation in the lungs, thereby preventing symptoms such as wheezing and shortness of breath.

  • In February 2026, The FDA has approved GSK’s Exdensur (depemokimab) for treating severe asthma in patients aged 12 years and older. The approval is supported by data from the SWIFT trials, which demonstrated the drug’s effectiveness in significantly reducing exacerbations. As the first ultra-long-acting biologic with a six-month dosing interval, depemokimab marks a major shift in asthma management, transitioning from monthly or bi-monthly injections to a twice-yearly treatment approach.

  • In December 2025, GlaxoSmithKline announced that the US FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance therapy for severe asthma with an eosinophilic phenotype in patients aged 12 years and older. Exdensur is the first ultra-long-acting biologic under evaluation for respiratory conditions driven by type 2 inflammation, including severe asthma, and has been designed with an extended half-life to support twice-yearly dosing. The approval is supported by results from the Phase III SWIFT-1 and SWIFT-2 trials, where depemokimab showed a sustained reduction in exacerbations with just two doses annually compared to placebo, alongside standard care.

  • In September 2025, Areteia Therapeutics reported positive Phase III results from the EXHALE-4 study, which assessed dexpramipexole as an oral add-on treatment for eosinophilic asthma. The results highlight the drug’s potential to enhance outcomes in patients with this severe form of asthma.

  • In September 2025, The U.S. Prescribing Information for AIRSUPRA has been updated to incorporate findings from the Phase IIIb BATURA study, which demonstrated that using AIRSUPRA as needed lowered the risk of severe asthma exacerbations by 46% compared to albuterol in adults with mild asthma.

  • In May 2025, AstraZeneca’s triple-combination therapy, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), achieved its primary goals in two Phase III clinical trials for asthma. In the KALOS (NCT04609878) and LOGOS (NCT04609904) studies, Breztri demonstrated statistically significant and clinically meaningful improvements in lung function compared to dual-combination ICS/LABA treatments. These randomized, double-blind trials involved a total of 4,434 patients with uncontrolled asthma, aiming to evaluate Breztri as a potential therapeutic option.

  • In March 2025, Connect Biopharma Holdings Limited (Nasdaq: CNTB), a clinical-stage biopharmaceutical company focused on advancing treatments for asthma and Chronic Obstructive Pulmonary Disease (COPD), announced encouraging findings from its global Phase 2 trial of rademikibart. Published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), the results highlight the potential of rademikibart as an innovative biologic therapy for individuals with moderate-to-severe uncontrolled asthma linked to Type 2 inflammation. The study reported a rapid onset of action, consistent improvements in lung function (FEV1), and notable reductions in the annual rate of asthma exacerbations.

  • In October 2024, AstraZeneca announced positive top-line results from its Phase IIIb BATURA trial, demonstrating that AIRSUPRA® (a combination of albuterol and budesonide) successfully met its primary endpoint. When used as an as-needed rescue therapy, AIRSUPRA® significantly lowered the risk of severe asthma exacerbations compared to albuterol alone. The study involved patients with intermittent or mild persistent asthma, including those using short-acting beta2-agonists (SABA), low-dose inhaled corticosteroids (ICS), or leukotriene receptor antagonists (LTRA) for maintenance therapy.

  • In September 2024, Kinaset Therapeutics presented two oral sessions and a late-breaking poster at the 2024 European Respiratory Society (ERS) Congress, highlighting the potential of its lead clinical asset, frevecitinib (KN-002), as a promising treatment for individuals with moderate to severe asthma and chronic obstructive pulmonary disease (COPD).

 

Asthma Overview

Asthma is a chronic lung condition that causes inflammation and narrowing of the airways, leading to difficulty in breathing. Common symptoms include wheezing, coughing, chest tightness, and shortness of breath. It can be triggered by allergens, exercise, cold air, or respiratory infections. While asthma has no cure, it can be effectively managed with medications like inhalers and by avoiding triggers.

 

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https://www.delveinsight.com/report-store/asthma-pipeline-insight

 

Emerging Asthma Drugs Under Different Phases of Clinical Development Include:

  • DUPIXENT (dupilumab): Sanofi/Regeneron Pharmaceuticals

  • TEZSPIRE (tezepelumab): Amgen/AstraZeneca

  • FASENRA (benralizumab): AstraZeneca

  • Dexpramipexole: Areteia Therapeutic

  • Depemokimab (GSK3511294): GlaxoSmithKline

  • BREZTRI AEROSPHERE (BGF; PT-010): AstraZeneca

  • LNR 125.38: Lanier Biotherapeutics

  • BAT2606: Bio-Thera Solutions

  • KN-002: Kinaset Therapeutics

  • CM326: CSPC ZhongQi Pharmaceutical Technology

  • FB 704A: Oneness Biotech Co., Ltd.

  • TQC2731: Chia Tai Tianqing Pharmaceutical Group

  • Masitinib: AB Science

  • GSK3511294: GlaxoSmithKline

 

Asthma Pipeline Therapeutics Assessment

  • Asthma Assessment by Product Type

  • Asthma By Stage and Product Type

  • Asthma Assessment by Route of Administration

  • Asthma By Stage and Route of Administration

  • Asthma Assessment by Molecule Type

  • Asthma by Stage and Molecule Type

 

DelveInsight's Asthma Report covers around 90+ 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 Asthma product details are provided in the report. Download the Asthma pipeline report to learn more about the emerging Asthma therapies

 

Some of the key companies in the Asthma Therapeutics Market include:

Key companies developing therapies for 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.

 

Asthma Pipeline Analysis:

The Asthma pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Asthma 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 Asthma Treatment.

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

  • 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.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the 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 Asthma drugs and therapies

 

Asthma Pipeline Market Drivers

  • Increase in the prevalence of Asthma, development of new and innovative treatment options for severe asthma are some of the important factors that are fueling the Asthma Market.

 

Asthma Pipeline Market Barriers

  • However, high cost of asthma medications, poor adherence to treatment, limited efficacy of existing treatments and other factors are creating obstacles in the Asthma Market growth.

 

Scope of Asthma Pipeline Drug Insight

  • Coverage: Global

  • Key Asthma Companies: Sanofi, Regeneron Pharmaceuticals, Amgen, Areteia Therapeutic, GlaxoSmithKline, Lanier Biotherapeutics, Bio-Thera Solutions, Kinaset Therapeutics, CSPC ZhongQi Pharmaceutical Technology, Oneness Biotech Co., Ltd., Chia Tai Tianqing Pharmaceutical Group, AB Science and others

  • Key Asthma Therapies: DUPIXENT (dupilumab), TEZSPIRE (tezepelumab), FASENRA (benralizumab), Dexpramipexole, Depemokimab (GSK3511294), BREZTRI AEROSPHERE (BGF; PT-010), LNR 125.38, BAT2606, KN-002, CM326, FB 704A, TQC2731, Masitinib, GSK3511294, and others

  • Asthma Therapeutic Assessment: Asthma current marketed and Asthma emerging therapies

  • Asthma Market Dynamics: Asthma market drivers and Asthma market barriers

 

Request for Sample PDF Report for Asthma Pipeline Assessment and clinical trials

 

Table of Contents

1. Asthma Report Introduction

2. Asthma Executive Summary

3. Asthma Overview

4. Asthma- Analytical Perspective In-depth Commercial Assessment

5. Asthma Pipeline Therapeutics

6. Asthma Late Stage Products (Phase II/III)

7. Asthma Mid Stage Products (Phase II)

8. Asthma Early Stage Products (Phase I)

9. Asthma Preclinical Stage Products

10. Asthma Therapeutics Assessment

11. Asthma Inactive Products

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

13. Asthma Key Companies

14. Asthma Key Products

15. Asthma Unmet Needs

16 . Asthma Market Drivers and Barriers

17. Asthma Future Perspectives and Conclusion

18. 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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