Severe Asthma FDA Approvals, Clinical Trials, Emerging Drugs, Pipeline Insights and Companies
DelveInsight's, 'Severe Asthma Pipeline Insight' report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in Severe Asthma pipeline landscape. It covers the Severe Asthma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Severe Asthma Treatment Landscape. Click here to read more @ Severe Asthma Pipeline Outlook
Key Takeaways from the Severe Asthma Pipeline Report
In January 2025:- AstraZeneca:- This is a multicentre, randomised, open-label, parallel-group, phase IIIb study to assess the potential for tezepelumab-treated patients to (1) reduce maintenance therapy without the loss of asthma control at Week 56, among those who demonstrated asthma control or low biomarkers at Week 24, and (2) be in asthma control and have characteristics of clinical remission at Week 24.
In January 2025: Upstream Bio Inc.:- The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.
In January 2025:- Incyte Corporation:- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma. The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function.
DelveInsight's Severe Asthma Pipeline analysis depicts a robust space with 40+ active players working to develop 50+ pipeline treatment therapies.
The leading Severe Asthma Companies such as 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.
Promising Severe Asthma Therapies such as Verekitug (UPB-101), FB704A, TQC2731, Benralizumab, povorcitinib, CM326, and others.
Stay informed about the cutting-edge advancements in Severe Asthma treatments. Download for updates and be a part of the revolution in Respiratory Diseases care @ Severe Asthma Clinical Trials Assessment
GSK3511294: GlaxoSmithKline
GSK 3511294, also known as depemokimab, is a long acting, interleukin-5 (IL-5) receptor antagonistic monoclonal antibody, being developed by GlaxoSmithKline, for the treatment of asthma. GSK3511294 is a humanized anti-interleukin (IL)-5 monoclonal antibody (mAb) engineered for extended half-life and improved IL-5 affinity versus other anti-IL-5 mAbs. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of severe asthma.
BSI-045B: Biosion
BSI-045B is a high-affinity, humanized monoclonal antibody, targeting thymic stromal lymphopoietin (TSLP), a cytokine that is implicated in the pathogenesis of atopic dermatitis, asthma and other eosinophilic and Th2 immune-related diseases. Biosion's collaboration partner - CTTQ, a China-based pharmaceutical company with rights to BSI-045B (TQC2731) for China development and commercialization, is currently conducting a Phase II clinical trial of BSI-045B in China for the treatment of severe uncontrolled asthma.
Mepolizumab: Bio-Thera Solutions
Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody administered subcutaneously via syringe or autoinjector. It is currently indicated for several conditions: as an add-on maintenance treatment for adult and pediatric patients aged six years and older with severe asthma characterized by an eosinophilic phenotype; as an add-on maintenance treatment for adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps; for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis; and for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome of at least six months' duration without an identifiable non-hematologic secondary cause. Currently the drug is in Phase I stage of its clinical trial for the treatment of severe asthma.
Severe Asthma 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 Branded Pharmaceutical Industries, and others.
Oral
Intravenous
Subcutaneous
Parenteral
Topical
Severe Asthma Products have been categorized under various Molecule types such as
Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy
Unveil the future of Severe Asthma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Severe Asthma Market Drivers and Barriers
Scope of the Severe Asthma Pipeline Report
Coverage- Global
Severe Asthma 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 Branded Pharmaceutical Industries, and others.
Severe Asthma Therapies- Verekitug (UPB-101), FB704A, TQC2731, Benralizumab, povorcitinib, CM326, and others.
Severe Asthma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Severe Asthma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Table of Content
Introduction
Executive Summary
Severe Asthma: Overview
Pipeline Therapeutics
Therapeutic Assessment
Severe Asthma– DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
GSK3511294: GlaxoSmithKline
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
BSI-045B: Biosion
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
Mepolizumab: Bio-Thera Solutions
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
Drug name: Company name
Drug profiles in the detailed report…..
Inactive Products
Severe Asthma Key Companies
Severe Asthma Key Products
Severe Asthma- Unmet Needs
Severe Asthma- Market Drivers and Barriers
Severe Asthma- Future Perspectives and Conclusion
Severe Asthma Analyst Views
Severe Asthma Key Companies
Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Early stage products (Phase I) VIB7734: Viela Bio Drug profiles in the detailed report….. Inactive Products Systemic Sclerosis Key Companies Systemic Sclerosis Key Products Systemic Sclerosis- Unmet Needs Systemic Sclerosis- Market Drivers and Barriers Systemic Sclerosis- Future Perspectives and Conclusion Systemic Sclerosis Analyst Views Systemic Sclerosis Key Companies 23. Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. 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- Globe and Mail
Merck Secures FDA Nod for New RSV Antibody Enflonsia in Infants
Merck MRK announced FDA approval for its prophylactic long-acting monoclonal antibody, clesrovimab, for the prevention of RSV in newborns and infants born during or entering their first RSV season. The drug will be marketed under the brand name Enflonsia. The FDA's decision came a day ahead of the previously announced target date of June 10, 2025. The approval is based on data from the pivotal phase IIb/III CLEVER study, which showed that treatment with a single dose of Enflonsia significantly reduced the incidence of RSV disease and hospitalization in healthy preterm and full-term infants. Merck plans to launch Enflonsia in the United States ahead of the upcoming 2025-26 RSV season and expects ordering for the shots to start next month. Per a Reuters article, Merck will price the antibody at $556 per dose. Merck's Stock Performance Year to date, Merck's shares have lost 20% compared with the industry 's 1% decline. Other RSV Antibodies/Vaccines Available in the Market Once commercially launched, Merck's Enflonsia will face stiff competition from AstraZeneca AZN / Sanofi 's SNY RSV antibody Beyfortus, which was also approved for a similar indication in 2023. This AstraZeneca-Sanofi antibody achieved blockbuster status in its first full-year sales in 2024. Coincidentally, on the same day Enflonsia received approval, Sanofi revealed an aggressive effort to increase the supply of the AstraZeneca-partnered Beyfortus, including a plan to start shipping the antibody early in the third quarter of 2025. While there are multiple vaccines approved for preventing RSV in the United States, the only one approved for immunizing infants is Pfizer 's PFE Abrysvo. Unlike Beyfortus and Enflonsia, which can be administered directly, the Pfizer vaccine protects infants through maternal immunization. Most of the marketed RSV vaccines, including Pfizer's, are approved for use in older adults aged 60 years and above. MRK's Cholesterol Drug Meets Goal in Two Late-Stage Studies In a separate press release, Merck announced topline data from two phase III studies, CORALreef HeFH and CORALreef AddOn, which evaluated their investigational oral PCSK9 inhibitor, enlicitide decanoate, in adults with hyperlipidemia who had been previously treated with a statin. Both studies met their primary and key secondary endpoints, showing statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) after treatment with enlicitide. While the CORALreef HeFH evaluated the drug against a placebo, the CORALreef AddOn assessed the drug against other oral non-statin therapies. MRK's Zacks Rank Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Only $1 to See All Zacks' Buys and Sells We're not kidding. Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent. Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators, and more, that closed 256 positions with double- and triple-digit gains in 2024 alone. See Stocks Now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report This article originally published on Zacks Investment Research (
