Dublin, Oct. 22, 2025 (GLOBE NEWSWIRE) -- The "Chronic Spontaneous Urticaria - Pipeline Insight, 2025" has been added to ResearchAndMarkets.com's offering.
The report offers an in-depth analysis of over 20 companies and 25 pipeline drugs within the Chronic Spontaneous Urticaria (CSU) landscape. The study includes detailed profiles of both clinical and nonclinical stage products, encompassing therapeutics assessments segmented by product type, development stage, route of administration, and molecule type, as well as information on inactive pipeline products.
Chronic Spontaneous Urticaria (CSU), also referred to as chronic idiopathic urticaria, manifests unpredictably without a clear external trigger. It often involves autoimmune mechanisms leading to the activation of mast cells. These cells release histamine and other mediators, resulting in symptoms such as itchy welts and angioedema. Though autoimmune thyroid disease, infections, or stress can be associated factors, many cases remain idiopathic. Effective management includes limiting investigations to necessary tests like differential blood count and C-reactive protein levels while utilizing treatments such as antihistamines and omalizumab.
The report outlines current and emerging therapeutic solutions for CSU and details ongoing R&D efforts by highlighting challenges, opportunities, and the impact of these new therapies. Treatments are in various development phases, from preclinical to advanced stages, with descriptions including mechanisms of action, clinical trials, and approvals.
Highlighted emerging drugs in the report include:
- Remibrutinib by Novartis: A highly selective, oral BTK inhibitor shown to be well-tolerated in Phase II trials, Remibrutinib blocks histamine release, providing rapid efficacy for moderate to severe cases of CSU. It shows potential as a complement to injectable biologics like omalizumab.
- Barzolvolimab by Celldex Therapeutics: A monoclonal antibody that targets the KIT receptor, crucial in mast cell activation. Successful Phase II results indicate potential for broader applications beyond CSU, including other mast cell-driven disorders.
- JYB1904 by Jemincare: A novel anti-IgE monoclonal antibody reducing free IgE levels and showing promise in Phase I trials with a more extended half-life than existing treatments.
- YH35324 by Yuhan Corporation: Engineered to neutralize free IgE, this fusion protein offers a long-acting alternative demonstrated to outperform current options in early trials.
Additionally, the report includes insights into significant collaborations, mergers, licensing activities, and unmet needs in CSU treatment. Key players such as Novartis, Celldex Therapeutics, and Yuhan Corporation are driving new solutions into upcoming clinical phases.
Overall, the report provides a comprehensive outlook on existing and forthcoming CSU therapies, offering valuable insights for stakeholders and researchers involved in the development of new CSU treatments.
Key Topics Covered:
Introduction
Executive Summary
Chronic Spontaneous Urticaria: Overview
- Causes
- Mechanism of Action
- Signs and Symptoms
- Diagnosis
- Disease Management
Pipeline Therapeutics
- Comparative Analysis
Therapeutic Assessment
- Assessment by Product Type
- Assessment by Stage and Product Type
- Assessment by Route of Administration
- Assessment by Stage and Route of Administration
- Assessment by Molecule Type
- Assessment by Stage and Molecule Type
Chronic Spontaneous Urticaria - Analytical Perspective
Late Stage Products (Phase III)
- Comparative Analysis
Barzolvolimab: Celldex Therapeutics
- Product Description
- Research and Development
- Product Development Activities
Mid Stage Products (Phase II)
- Comparative Analysis
JYB1904: Jemincare
- Product Description
- Research and Development
- Product Development Activities
Early Stage Products (Phase I)
- Comparative Analysis
YH35324: Yuhan Corporation
- Product Description
- Research and Development
- Product Development Activities
Preclinical and Discovery Stage Products
- Comparative Analysis
Drug Name: Company Name
- Product Description
- Research and Development
- Product Development Activities
Inactive Products
- Comparative Analysis
Chronic Spontaneous Urticaria Key Companies
Chronic Spontaneous Urticaria Key Products
Chronic Spontaneous Urticaria - Unmet Needs
Chronic Spontaneous Urticaria - Market Drivers and Barriers
Chronic Spontaneous Urticaria - Future Perspectives and Conclusion
Chronic Spontaneous Urticaria Analyst Views
Chronic Spontaneous Urticaria Key Companies
- Novartis
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Celldex Therapeutics
- Jemincare
- Yuhan Corporation
- United BioPharma
- Septerna
- Recludix Pharma
For more information about this clinical trials report visit https://www.researchandmarkets.com/r/epkpdc
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