The chronic urticaria clinical trial analysis report delivers important insights into ongoing research of 30+ pipeline chronic urticaria drugs, clinical strategies, upcoming therapeutics, and commercial analysis.

New York, USA, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Chronic Urticaria Clinical Trial Landscape Becomes Increasingly Crowded with 20+ Pharma Companies | DelveInsight

DelveInsight’s 'Chronic Urticaria Pipeline Insight 2026' report provides comprehensive global coverage of pipeline therapies for chronic urticaria across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and competitive landscape dynamics, highlighting the strategies of major pharmaceutical companies to advance the pipeline and capitalize on future growth opportunities. In addition, it includes critical insights into clinical trial benchmarking, partnering and licensing activities, and regulatory pathways involving the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies within the chronic urticaria domain.

Chronic Urticaria Clinical Trial Analysis Summary

DelveInsight’s chronic urticaria pipeline report depicts a robust space with 20+ active players working to develop 30+ pipeline chronic urticaria drugs.
Key chronic urticaria companies, such as Celldex Therapeutics Inc., United BioPharma, Sanofi, Enanta Pharmaceuticals, Alys Pharmaceuticals, Hangzhou Highlightll Pharmaceutical, Jemincare, Yuhan Corporation, Septerna, Novartis, Jiangsu Hansoh Pharmaceutical Co., Ltd., Evommune, BeiGene, Longbio Pharma, Belenos Biosciences, and others, are evaluating new chronic urticaria drugs to improve the treatment landscape.
Promising pipeline chronic urticaria therapies, such as Barzolvolimab, UB-221, SAR449028, EDP-978, ALY-301, Girocitinib, JYB-1904, YH35324, SEP-631, KRP M223, HS-10561, EVO756, BGB-16673, LP-003, BEL-512, and others, are in different phases of chronic urticaria clinical trials.
Approximately 12+ chronic urticaria drugs are in the late and mid stages of development.
Notable MoAs in chronic urticaria clinical trials include KIT inhibitor, TYK2/JAK1 inhibitor, IgE receptor antagonist, Immunoglobulin E inhibitors, Wild-type KIT inhibitor, Mast cell-selective c-Kit inhibitor, MRGPRX2 antagonist, and others.

Request a sample and discover the chronic urticaria treatment guidelines 2026 @ https://www.delveinsight.com/report-store/chronic-urticaria-or-hives-pipeline-insight

What is Chronic Urticaria?

Chronic urticaria is a skin disorder characterized by the recurrent appearance of itchy wheals, angioedema, or both for a period of six weeks or longer. The condition results from the activation and degranulation of mast cells and basophils, releasing histamine and other inflammatory mediators that cause localized swelling, redness, and pruritus. Chronic urticaria is broadly classified into chronic spontaneous urticaria (CSU), in which symptoms occur without an identifiable external trigger, and chronic inducible urticaria (CIndU), where symptoms are provoked by specific physical or environmental stimuli such as pressure, cold, heat, or sunlight. Although the exact etiology remains unclear in many cases, autoimmune mechanisms, infections, and other underlying conditions have been implicated. Chronic urticaria can significantly impair patients' quality of life due to persistent itching, sleep disturbances, emotional distress, and reduced daily functioning.

Find out more about chronic urticaria criteria @ Chronic Urticaria Treatment Guidelines

A snapshot of the Pipeline Chronic Urticaria Drugs mentioned in the report:

Drugs	Company	Phase	MoA	RoA
Barzolvolimab	Celldex Therapeutics Inc.	III	KIT inhibitor	SC
TLL018	Hangzhou Highlightll Pharmaceutical Co., Ltd	III	TYK2/JAK1 inhibitor	Oral
JYB1904	Jemincare	III	Immunoglobulin E inhibitors	SC
UB-221	United BioPharma	II	IgE receptor antagonist	IV infusion
YH35324	Yuhan Corporation	II	Immunoglobulin E inhibitors	SC
SAR449028	Sanofi	II	Wild-type KIT inhibitor	Oral
EDP-978	Enanta Pharmaceuticals	I	KIT Inhibitor	Oral
ALY-301	Alys Pharmaceuticals	Phase I	Mast cell-selective c-Kit inhibitor	IV
KRP M223	Novartis	Preclinical	MRGPRX2 antagonist	NA

Learn more about the chronic urticaria competitive analysis @ Chronic Urticaria or Hives Clinical Trials Analysis

As per Stuti Mahajan, Consulting Manager at DelveInsight, chronic urticaria is a persistent inflammatory skin disorder with increasing clinical and commercial focus, driven by rising disease recognition, unmet needs, and the advent of targeted biologic therapies. The market is expanding steadily, supported by improved diagnosis and greater awareness among physicians and patients. Ongoing innovation and an evolving treatment landscape are expected to sustain growth while increasing competition among established and emerging therapies.

Recent Developments in Chronic Urticaria Treatment Space

In April 2026, Enanta Pharmaceuticals, Inc. announced that the first participant has been dosed in a Phase I clinical trial of EDP-978, an oral, once-daily KIT inhibitor in development for urticaria and other mast cell-driven diseases. The Phase I single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of EDP-978 in healthy adult volunteers.
In April 2026, Cue Biopharma, Inc. announced that it has entered into an exclusive license agreement with Ascendant Health Sciences Ltd. to develop, manufacture and commercialize Ascendant-221, a Phase II clinical stage anti-IgE monoclonal antibody for the treatment of allergic diseases. Ascendant-221 is currently being evaluated by Ascendant Health’s related company, Genesis Life Sciences, in a Phase II placebo and active comparator-controlled dose-ranging study in chronic spontaneous urticaria (CSU) in China with clinical results expected in 2H 2026.
In March 2026, Septerna, Inc. announced positive results from its Phase I clinical trial evaluating SEP-631. Based on these results, Septerna plans to advance SEP-631 into Phase II development for chronic spontaneous urticaria (CSU) and continue evaluation of additional mast cell-driven indications.
In February 2026, Celldex announced the completion of enrollment in the Company’s global Phase III program of barzolvolimab in chronic spontaneous urticaria (CSU), which consists of two Phase III trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled, the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites.
In January 2026, Highlightll announced positive topline data from its Phase III clinical trial evaluating Girocitinib (TLL-018), an oral small-molecule JAK1/TYK2 inhibitor, for the treatment of chronic spontaneous urticaria (CSU).
In December 2025, Celldex announced the initiation of its global Phase III trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment.
In November 2025, Alys Pharmaceuticals announced the dosing of the first subject in a Phase I/Ib clinical study of ALY-301, a first-in-class mast cell–selective c-Kit inhibitor being developed for cold urticaria, a subtype of chronic inducible urticaria (CIndU) and a representative model for the broader chronic urticaria population.
In May 2025, Evommune, Inc. announced positive top-line data from its Phase II trial of EVO756 in adults with chronic inducible urticaria (CIndU).

Scope of the Chronic Urticaria Pipeline Report

Coverage: Global
Chronic Urticaria Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
Chronic Urticaria Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Chronic Urticaria Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
Chronic Urticaria Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
Chronic Urticaria Therapeutics Assessment By Mechanism of Action: KIT inhibitor, TYK2/JAK1 inhibitor, IgE receptor antagonist, Immunoglobulin E inhibitors, Wild-type KIT inhibitor, Mast cell-selective c-Kit inhibitor, MRGPRX2 antagonist, and others
Key Chronic Urticaria Companies: Celldex Therapeutics Inc., United BioPharma, Sanofi, Enanta Pharmaceuticals, Alys Pharmaceuticals, Hangzhou Highlightll Pharmaceutical, Jemincare, Yuhan Corporation, Septerna, Novartis, Jiangsu Hansoh Pharmaceutical Co., Ltd., Evommune, BeiGene, Longbio Pharma, Belenos Biosciences and others.
Key Chronic Urticaria Pipeline Therapies: Barzolvolimab, UB-221, SAR449028, EDP-978, ALY-301, Girocitinib, JYB-1904, YH35324, SEP-631, KRP M223, HS-10561, EVO756, BGB-16673, LP-003, BEL-512 and others.

Dive deep into rich insights for chronic urticaria treatment options, visit @ Chronic Urticaria Management Guidelines

Table of Contents

1.	Chronic Urticaria Pipeline Report Introduction
2.	Chronic Urticaria Pipeline Report Executive Summary
3.	Chronic Urticaria Pipeline: Overview
4.	Analytical Perspective In-depth Commercial Assessment
5.	Chronic Urticaria Clinical Trial Therapeutics
6.	Chronic Urticaria Pipeline: Late-Stage Products (Pre-registration)
7.	Chronic Urticaria Pipeline: Late-Stage Products (Phase III)
8.	Chronic Urticaria Pipeline: Mid-Stage Products (Phase II)
9.	Chronic Urticaria Pipeline: Early-Stage Products (Phase I)
10.	Chronic Urticaria Pipeline Therapeutics Assessment
11.	Inactive Products in the Chronic Urticaria Pipeline
12.	Company-University Collaborations (Licensing/Partnering) Analysis
13.	Key Companies
14.	Key Products in the Chronic Urticaria Pipeline
15.	Unmet Needs
16.	Market Drivers and Barriers
17.	Future Perspectives and Conclusion
18.	Analyst Views
19.	Appendix

For further information on the new treatments for chronic urticaria, reach out @ Medication for Chronic Urticaria Treatment

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