Chronic Spontaneous Urticaria Pipeline Drugs Report 2025: Emerging Therapies, Clinical Developments, and Drug Insights by DelveInsight

DelveInsight's "Chronic Spontaneous Urticaria Pipeline Insight 2025" report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in the Chronic Spontaneous Urticaria pipeline landscape. It covers the Chronic Spontaneous Urticaria Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Chronic Spontaneous Urticaria Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Chronic Spontaneous Urticaria Pipeline Report

* On 07 October 2025, Teva Pharmaceuticals USA announced a study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.
* On 02 October 2025, ARS Pharmaceuticals Inc. initiated a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).
* DelveInsight's Chronic Spontaneous Urticaria Pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Chronic Spontaneous Urticaria treatment.
* The leading Chronic Spontaneous Urticaria Companies such as Novartis, Hangzhou Highlightll Pharmaceutical Co., Ltd, Celldex Therapeutics, Jemincare, Yuhan Corporation, United BioPharma, Septerna, Recludix Pharma and others.
* Promising Chronic Spontaneous Urticaria Therapies such as EVO756, barzolvolimab, CMAB007, JYB1904, Omalizumab, CT-P39, LOU064, Ligelizumab, Omalizumab and others.

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The Chronic Spontaneous Urticaria Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Chronic Spontaneous Urticaria Pipeline Report also highlights the unmet needs with respect to the Chronic Spontaneous Urticaria.

Chronic Spontaneous Urticaria Overview

Chronic Spontaneous Urticaria (CSU) is defined as hives that are present for at least or greater than 6 weeks and for the most days of the week. Chronic spontaneous urticaria is characterized by the presence of weals and angioedema. Weals can affect any site on the body and tend to be distributed widely. Chronic urticaria is diagnosed is based on a history lasting over 6 weeks of daily or episodic weals that last less than 24 hours without the presence of physical trigger factors. The international guidelines recommend limiting investigations in most patients with chronic spontaneous urticaria to differential blood count and erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Medicines for the treatment of chronic spontaneous urticarial are antihistamines, omalizumab, cyclosporine, and low-dose corticosteroids.

Chronic Spontaneous Urticaria Emerging Drugs Profile

* Remibrutinib: Novartis

Remibrutinib (LOU064) is a highly selective, oral Bruton's tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts and swelling. In Phase II studies, remibrutinib demonstrated fast onset of action and sustained efficacy in patients with moderate to severe chronic spontaneous urticaria (CSU). Remibrutinib has been shown to be well-tolerated across all doses studied in Phase II. These results have been confirmed by the Phase III REMIX data. In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, such as multiple sclerosis, hidradenitis suppurativa, food allergy and Sjogren's syndrome. If approved, remibrutinib has the potential to become an effective oral option to complement Xolair Registered (omalizumab), the first and only injectable biologic indicated for CSU. Currently the drug is Registered evaluation for the treatment of Chronic Spontaneous Urticaria.

* Barzolvolimab: Celldex Therapeutics

DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, Barzolvolimab (CDX0159), developed by Celldex Therapeutics, is a humanized monoclonal antibody that selectively binds and blocks the receptor tyrosine kinase KIT, a key regulator of mast cell survival and activation, making it a targeted therapy for mast cell-driven disorders . It has shown robust efficacy in Phase 2 trials for chronic spontaneous urticaria (CSU), delivering rapid, durable symptom relief-including up to a 24-point reduction in UAS7 score by week 12-and providing complete disease control in a high percentage of patients through week 52. Side effects have been generally mild and reversible, such as hair color changes and transient neutropenia. Celldex has launched global Phase III EMBARQ Registered trials in CSU and plans to expand into other indications, including chronic inducible urticaria, eosinophilic esophagitis, prurigo nodularis, and atopic dermatitis. With its potent mast cell-depleting mechanism, barzolvolimab holds promise to transform treatment across a range of chronic inflammatory and allergic conditions.

* JYB1904: Jemincare

JYB1904 is a novel, half-life-extended antiIgE monoclonal antibody developed by ShanghaiJemincare (licensed as RPT904 outside Greater China) designed to bind free IgE and prevent its interaction with FcRI on effector cells. In a Phase1 single-dose escalation trial in healthy volunteers, it demonstrated excellent safety (all AEs were Grade1-2), dose-proportional pharmacokinetics, and a median half-life over twice that of omalizumab-alongside deeper and more sustained suppression of free IgE and higher total IgE accumulation. Ongoing PhaseII studies in China are evaluating its PK/PD profile in allergic asthma (topline data expected late 2025) and its efficacy in chronic spontaneous urticaria (CSU). Backed by a global licensing deal with RAPT Therapeutics (excluding Greater China territories) that included a $35million upfront payment and up to $672.5million in milestones, JYB1904 shows promise as a longer-lasting, next-generation alternative to omalizumab for IgEmediated allergic diseases.

* YH35324: Yuhan Corporation

YH35324 is a novel, long-acting IgEtrap Fc fusion protein engineered by Yuhan Corporation to bind and neutralize free IgE via high-affinity FcRI interaction, preventing IgE-mediated activation of mast cells and basophils. In PhaseI trials involving subcutaneous single and multiple ascending doses in atopic adults and healthy volunteers, it demonstrated a favorable safety profile-mostly grade1/2 AEs with no serious events-and dose-proportional pharmacokinetics with prolonged IgE suppression that outperformed omalizumab, especially in individuals with high baseline IgE (>700IU/mL) . Mechanistic studies showed it effectively reduces FcRI expression on basophils and mast cells and remains active through FcRn-mediated recycling. With ongoing Phase1b studies in allergic diseases like chronic urticaria and atopic dermatitis. YH35324 offers a promising next-generation alternative to omalizumab for IgE-driven conditions.

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The Chronic Spontaneous Urticaria Pipeline report provides insights into:-

* The report provides detailed insights about companies that are developing therapies for the treatment of Chronic Spontaneous Urticaria 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 Chronic Spontaneous Urticaria Treatment.
* Chronic Spontaneous Urticaria Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Chronic Spontaneous Urticaria 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 Chronic Spontaneous Urticaria market.

Chronic Spontaneous Urticaria Companies

Novartis, Hangzhou Highlightll Pharmaceutical Co., Ltd, Celldex Therapeutics, Jemincare, Yuhan Corporation, United BioPharma, Septerna, Recludix Pharma and others.

Chronic Spontaneous Urticaria Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as,

* Intravenous
* Subcutaneous
* Oral
* Intramuscular

Chronic Spontaneous Urticaria Products have been categorized under various Molecule types such as,

* Monoclonal antibody
* Small molecule
* Peptide

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Scope of the Chronic Spontaneous Urticaria Pipeline Report

* Coverage- Global
* Chronic Spontaneous Urticaria Companies- Novartis, Hangzhou Highlightll Pharmaceutical Co., Ltd, Celldex Therapeutics, Jemincare, Yuhan Corporation, United BioPharma, Septerna, Recludix Pharma and others.
* Chronic Spontaneous Urticaria Therapies- EVO756, barzolvolimab, CMAB007, JYB1904, Omalizumab, CT-P39, LOU064, Ligelizumab, Omalizumab and others.
* Chronic Spontaneous Urticaria Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Chronic Spontaneous Urticaria Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Chronic Spontaneous Urticaria: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Chronic Spontaneous Urticaria- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Barzolvolimab: Celldex Therapeutics
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* JYB1904: Jemincare
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* YH35324: Yuhan Corporation
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* 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
* Appendix

About Us

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