Chronic Spontaneous Urticaria Treatment Landscape Set for Transformation with Innovative Pipeline Therapies
DelveInsight’s “Chronic Spontaneous Urticaria – Pipeline Insight, 2025” report offers an in-depth analysis of over 20+ companies and their 20+ pipeline therapies targeting Chronic Spontaneous Urticaria. The report includes detailed profiles of both clinical and preclinical Chronic Spontaneous Urticaria drug candidates, along with a comprehensive evaluation based on product type, development stage, route of administration, and molecule type. Additionally, it sheds light on discontinued or inactive pipeline products in this domain.
The chronic spontaneous urticaria pipeline landscape is experiencing unprecedented activity, with over 20 companies developing more than 20 pipeline drugs across various stages of clinical development. This comprehensive pipeline encompasses late-stage products in Phase III, mid-stage products in Phase II, early-stage products in Phase I, along with preclinical and discovery stage candidates.
The pipeline drugs are categorized across multiple routes of administration, including intravenous, subcutaneous, oral, and intramuscular delivery systems. The therapeutic candidates span various molecule types, including monoclonal antibodies, small molecules, and peptides, representing diverse approaches to treating this challenging condition.
Download the Chronic Spontaneous Urticaria Pipeline Report for in-depth Chronic Spontaneous Urticaria competitive insights.
Advanced Pipeline Candidates in Late-Stage DevelopmentPhase III Clinical Trials
Remibrutinib (Novartis): This oral Bruton’s tyrosine kinase inhibitor has demonstrated significant long-term efficacy and safety in Phase III trials (REMIX-1 and REMIX-2). Novartis announced in July 2025 that a Phase 3b study is currently ongoing to assess efficacy, safety, and tolerability in comparison to placebo and omalizumab.
Rilzabrutinib (Sanofi): Another oral BTK inhibitor that showed positive results in the Phase II RILECSU study. This represents Sanofi’s continued investment in the BTK inhibitor pathway for chronic spontaneous urticaria treatment.
TLL-018 (Hangzhou Highlightll Pharmaceutical): Currently in Phase III development, this oral therapy is being evaluated in a multicenter, randomized, double-blind, placebo-controlled study involving participants with moderate-to-severe chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.
CT-P39 (Celltrion): A biosimilar to XOLAIR that has completed Phase III trials in January 2025, involving 619 patients with chronic spontaneous urticaria across six countries. The trial demonstrated bioequivalence to the reference product, with similar results in secondary endpoints of efficacy, pharmacokinetics, safety, and immunogenicity.
Phase II Development Programs
Tezepelumab (AstraZeneca/Amgen): A first-in-class monoclonal antibody inhibiting thymic stromal lymphopoietin has completed Phase II trials in the first quarter of 2025. Despite not meeting the primary endpoint at 16 weeks, the drug demonstrated delayed, sustained reductions in chronic spontaneous urticaria activity through week 32, particularly in anti-IgE therapy-naive patients.
Barzolvolimab (Celldex Therapeutics): In June 2025, Celldex Therapeutics Inc. (CLDX) reported promising Phase 2 Results for this humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT. The drug demonstrated significant improvements in angioedema symptoms, with 77% of patients being angioedema-free at Week 52 and up to 87% reporting clinically meaningful improvement in angioedema activity scores.
Early-Stage and Novel Mechanisms
YH35324 (Yuhan Corporation): An IgE inhibitor designed based on IgE Trap-Fc fusion protein technology that has demonstrated positive results in Phase I clinical trials. The drug showed superior IgE reduction compared to existing therapies and demonstrated efficacy even in omalizumab-refractory patients, according to the study’s abstract published in June 2025.
Explore the Chronic Spontaneous Urticaria pipeline landscape and stay ahead with insights into the most promising chronic spontaneous urticaria therapies in development. Download the complete report now!
Current Treatment Paradigm and Emerging Alternatives
The current chronic spontaneous urticaria treatment paradigm follows a stepwise approach, beginning with second-generation H1-antihistamines as first-line therapy, followed by up-dosing to fourfold in refractory cases. For patients unresponsive to antihistamines, Roche/Novartis’s XOLAIR, a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to IgE, remains the cornerstone therapy.
The recent approval of Sanofi/Regeneron’s DUPIXENT by the FDA in April 2025 for chronic spontaneous urticaria patients aged 12 years and older introduces a valuable alternative mechanism targeting IL-4 and IL-13 signaling pathways. This marks the first new targeted therapy in over a decade for chronic spontaneous urticaria.
Furthermore, in March 2025, Celltrion secured FDA approval for OMLYCLO (omalizumab-igec) as the first interchangeable biosimilar to XOLAIR, potentially improving treatment access and affordability.
Discover evolving trends in the Chronic Spontaneous Urticaria treatment landscape @ Chronic Spontaneous Urticaria Recent Developments.
Addressing Unmet Medical Needs
Despite therapeutic advances, significant challenges persist in chronic spontaneous urticaria management. Nearly one-third of patients remain symptomatic despite omalizumab treatment, and the subcutaneous administration route creates an additional burden for healthcare systems and patients. The high cost of biologics limits accessibility, particularly in restricted healthcare environments where more affordable options like H2-antagonists and dapsone maintain relevance despite not being included in formal treatment guidelines.
The comprehensive pipeline addressing these unmet needs includes oral BTK inhibitors that offer convenient administration, novel anti-IgE therapies with enhanced mechanisms of action, and upstream-targeted therapies that inhibit multiple pathways. These innovations highlight the importance of continued research and development in creating cost-effective, convenient, and efficacious treatments for this challenging dermatological condition.
As the understanding of chronic spontaneous urticaria pathophysiology continues to evolve, the treatment landscape is expected to transform dramatically with novel therapies addressing the significant unmet needs in this condition. The robust pipeline of over 20 companies developing diverse therapeutic approaches represents a promising future for patients suffering from this debilitating condition.
Table of Contents
1. Introduction
2. Executive Summary
3. Chronic Spontaneous Urticaria: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Chronic Spontaneous Urticaria– DelveInsight’s Analytical Perspective
7. Late-Stage Products (Preregistration)
8. Late-Stage Products (Phase III)
9. Mid-Stage Products (Phase II)
10. Early Stage Products (Phase I)
11. Preclinical and Discovery Stage Products
12. Inactive Products
13. Chronic Spontaneous Urticaria Key Companies
14. Chronic Spontaneous Urticaria Key Products
15. Chronic Spontaneous Urticaria- Unmet Needs
16. Chronic Spontaneous Urticaria- Market Drivers and Barriers
17. Chronic Spontaneous Urticaria- Future Perspectives and Conclusion
18. Chronic Spontaneous Urticaria Analyst Views
19. Chronic Spontaneous Urticaria Key Companies
20. Appendix
Related Reports
Chronic Spontaneous Urticaria Market Insight
DelveInsight’s Chronic Spontaneous Urticaria Market Insights, Epidemiology, and Market Forecast report offers a comprehensive analysis of Chronic Spontaneous Urticaria market, including detailed insights into its historical and projected Chronic Spontaneous Urticaria epidemiological trends and evolving treatment landscape across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services
