DelveInsight’s “Severe Asthma Pipeline Insight” report delivers a comprehensive assessment of the global severe asthma pipeline. The report evaluates 40+ companies and 50+ pipeline therapies, offering extensive commercial and clinical insights across development stages ranging from discovery and preclinical research to late-stage and marketed products.
It includes detailed drug-level intelligence covering mechanisms of action, clinical trial outcomes, regulatory progress such as NDA filings or approvals, and strategic development activities, including technology platforms, collaborations, mergers and acquisitions, funding initiatives, and special regulatory designations.
Gain Strategic Insights Into the Severe Asthma Treatment Landscape. Explore DelveInsight’s in-depth analysis to stay informed about evolving therapeutic trends in severe asthma. Click here to learn more @ Severe Asthma Pipeline Outlook
Key Highlights from the Severe Asthma Pipeline Report
- Depemokimab (GSK), a long-acting anti–IL-5 monoclonal antibody for severe type 2 inflammatory asthma, has been accepted for FDA review, with a regulatory decision anticipated by December 16, 2025.
- In October 2025, Chiesi USA, Inc. (key-A-zee), a biopharmaceutical company that supports patients in living their best possible lives through life-changing or lifesaving innovations, today announced that the U.S. Food and Drug Administration has accepted the company’s New Drug Application (NDA) for its investigational maintenance treatment of asthma in adults. Chiesi’s inhaler delivers three active ingredients in a single device, referred to as a single inhaler triple therapy (SITT). Already approved in nearly 50 countries, this product is marketed outside of the U.S. under the brand name TRIMBOW®.
- In March 2025, AstraZeneca initiated a study to assess whether adolescents and adults receiving subcutaneous tezepelumab can safely reduce maintenance therapy while sustaining asthma control.
- Upstream Bio Inc. launched a clinical trial in March 2025 evaluating verekitug (UPB-101) for safety and efficacy in severe asthma, focusing on exacerbation frequency, lung function, asthma control, and tolerability versus placebo.
- In January 2025, AstraZeneca commenced a multicenter, randomized, open-label Phase IIIb trial to determine if patients treated with tezepelumab can taper maintenance therapy by Week 56 and achieve remission-like outcomes by Week 24.
- Also in January 2025, Upstream Bio initiated an additional study of verekitug (UPB-101) to further examine its pharmacodynamics, efficacy, safety, and tolerability in severe asthma patients.
- Incyte Corporation began a Phase II, double-blind, placebo-controlled, dose-ranging study in January 2025 to evaluate povorcitinib and its effects on pulmonary function in individuals with inadequately controlled moderate-to-severe asthma.
- DelveInsight reports that the severe asthma pipeline remains highly dynamic, with 40+ companies collectively advancing more than 50 investigational therapies.
- Major players include Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva, and others.
- Prominent pipeline candidates include Verekitug (UPB-101), FB704A, TQC2731, Benralizumab, Povorcitinib, CM326, among several others.
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Emerging Drugs in the Severe Asthma Pipeline
GSK3511294 (Depemokimab) – GlaxoSmithKline
Depemokimab is a long-acting monoclonal antibody targeting the interleukin-5 (IL-5) receptor, engineered for prolonged half-life and enhanced binding affinity compared with earlier IL-5 inhibitors. Developed by GlaxoSmithKline, the therapy is currently undergoing Phase III clinical evaluation for severe asthma management.
BSI-045B – Biosion
BSI-045B is a humanized, high-affinity monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a cytokine implicated in asthma and other Th2-mediated inflammatory diseases. Biosion’s partner CTTQ, which holds development and commercialization rights in China, is conducting a Phase II clinical trial of TQC2731 in patients with severe uncontrolled asthma.
Mepolizumab – Bio-Thera Solutions
Mepolizumab is a subcutaneously administered IL-5 antagonist monoclonal antibody, delivered via syringe or autoinjector. It is approved as an add-on maintenance therapy for several eosinophilic conditions, including severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, EGPA, and hypereosinophilic syndrome. Bio-Thera Solutions is currently evaluating mepolizumab in a Phase I study for severe asthma.
Discover Transformative Therapies in the Severe Asthma Pipeline. Access DelveInsight’s detailed report to explore emerging drugs and active clinical programs @ Severe Asthma Treatment Drugs
Severe Asthma Companies Profiled
Key companies featured in the report include Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, and others.
Route of Administration Analysis
The severe asthma pipeline therapies are evaluated across multiple routes of administration, including:
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Molecule Type Classification
Pipeline products are categorized based on molecular modality, such as:
- Recombinant fusion proteins
- Small molecules
- Monoclonal antibodies
- Peptides
- Polymers
- Gene therapies
Understanding the Future of Severe Asthma Treatment. DelveInsight’s expert analysis sheds light on upcoming therapies, pipeline trends, and key players shaping the severe asthma market @ Severe Asthma Market Drivers and Barriers
Severe Asthma Market Drivers
- Rising Disease Prevalence: Increasing cases of eosinophilic and uncontrolled asthma are expanding the addressable patient population.
- Growing Use of Biologics: Advances in biologics targeting IL-5, IL-4/13, IgE, and TSLP are transforming disease management and reducing exacerbations.
- Improved Diagnostic Tools: Greater adoption of biomarkers, phenotyping, and precision medicine approaches is enhancing treatment selection.
- Increased Awareness and Access: Better physician education, patient awareness, and access to specialty centers are improving diagnosis and care.
- Supportive Reimbursement Policies: Favorable coverage in developed markets such as the US and EU is accelerating uptake of high-cost biologics.
- Robust R&D Activity: Strong pipeline momentum driven by innovation in long-acting biologics and next-generation anti-inflammatory targets.
Severe Asthma Market Challenges
- High Cost of Biologic Treatments: Premium pricing limits affordability and reimbursement in many regions.
- Diagnostic Complexity: Identifying specific asthma phenotypes requires advanced testing infrastructure.
- Adherence Barriers: Long-term treatment regimens and injectable therapies can affect patient compliance.
- Limited Penetration in Emerging Markets: Infrastructure gaps and financial constraints hinder adoption.
- Safety and Long-Term Risk Concerns: Potential adverse effects and limited long-term data may slow uptake.
- Regulatory and Access Hurdles: Prolonged approval timelines can delay market entry.
Scope of the Severe Asthma Pipeline Report
- Geographic Coverage: Global
- Key Companies: Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva, and others
- Key Therapies: Verekitug (UPB-101), FB704A, TQC2731, Benralizumab, Povorcitinib, CM326, and others
- Therapeutic Assessment: Mono, combination, and mono/combination therapies
- Development Stages Covered: Discovery, Preclinical, Phase I, Phase II, Phase III
Get the Latest Insights on Severe Asthma Therapies. Download DelveInsight’s comprehensive pipeline report to explore key products, companies, and unmet needs @ Severe Asthma Companies, Key Products and Unmet Needs
Table of Contents
- Introduction
- Executive Summary
- Severe Asthma Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- DelveInsight’s Analytical Perspective
- Late-Stage Products (Phase III)
- Mid-Stage Products (Phase II)
- Early-Stage Products (Phase I)
- Preclinical & Discovery Programs
- Inactive Products
- Key Companies & Products
- Unmet Needs
- Market Drivers & Barriers
- Future Outlook & Conclusion
- Analyst Views
- Appendix
About DelveInsight
DelveInsight is a leading life sciences–focused market research and consulting firm providing high-quality intelligence and strategic insights to pharmaceutical and healthcare organizations worldwide. With deep industry expertise and customized research solutions, DelveInsight supports informed decision-making and helps clients stay ahead in an evolving healthcare landscape.
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