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Urticaria Pipeline 2025: MOA and ROA Insights, Clinical Trials Status, and Key Companies Involved by DelveInsight | Sanofi, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, Roche, Novartis, GlaxoSmithKline

07-21-2025 10:00 PM CET | Health & Medicine

Press release from: DelveInsight Business Research

Urticaria Pipeline 2025: MOA and ROA Insights, Clinical Trials

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Urticaria pipeline constitutes 20+ key companies continuously working towards developing 25+ Urticaria treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Urticaria Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Urticaria Market.

The Urticaria Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Urticaria Pipeline Report: https://www.delveinsight.com/sample-request/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Urticaria treatment therapies with a considerable amount of success over the years.
• Urticaria companies working in the treatment market are Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, Regeneron, GlaxoSmithKline, Taiho Pharma, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, and others, are developing therapies for the Urticaria treatment
• Emerging Urticaria therapies in the different phases of clinical trials are- Ligelizumab, Remibrutinib (LOU064), Tezepelumab, CDX-0159, GI-301, Dupilumab (DUPIXENT), UB-221, MTPS9579A, Lirentelimab (AK002), TAS5315, rilzabrutinib, GDC-0853, AZD1981, Desloratadine, and others are expected to have a significant impact on the Urticaria market in the coming years.
• In March 2025, Results from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials reveal that remibrutinib significantly alleviates symptoms of chronic spontaneous urticaria (CSU) in patients who do not respond to second-generation H1-antihistamines. The treatment demonstrated a rapid onset of action, sustained effectiveness over 24 weeks, and a favorable safety profile, as reported in The New England Journal of Medicine.
• In January 2025, Jasper Therapeutics, Inc. (Nasdaq: JSPR), a clinical-stage biotechnology company developing briquilimab, a novel antibody therapy targeting c-Kit (CD117) for mast cell-driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma, announced positive preliminary data from its ongoing BEACON Phase 1b/2a study of subcutaneous briquilimab in adults with CSU. The study showed significant reductions in UAS7 scores, with an average change of -26.6 at eight weeks in the 240mg single-dose cohort, while multiple dosing regimens of 120mg or higher demonstrated UAS7 reductions exceeding -25 points. Clinical responses were observed as early as one week after the first dose, with some patients achieving Complete Responses (UAS7 = 0) at all therapeutic dose levels (80mg, 120mg, 180mg, and 240mg). Notably, all patients in the 240mg single-dose cohort (N=3) maintained Complete Responses through the eight-week period.
• In September 2024, Regeneron Pharmaceuticals and Sanofi reported that the confirmatory Phase III trial (LIBERTY-CUPID Study C) for Dupixent (dupilumab) successfully achieved its primary and key secondary endpoints. The study evaluated Dupixent as an investigational treatment for patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) who were also receiving background antihistamine therapy.
• In September 2024, Evommune announced that the first patient has been enrolled in a Phase II clinical trial evaluating EVO756 in adults with CIndU.
• In June 2024, Celldex Therapeutics reported data showing that barzolvolimab significantly improves angioedema at 12 weeks in its Phase II clinical trial for chronic spontaneous urticaria (CSU).
• In May 2024, Novartis released new data confirming the long-term efficacy and safety of remibrutinib, a highly selective Bruton's tyrosine kinase (BTK) inhibitor, for chronic spontaneous urticaria (CSU).
• In March 2024, Jasper Therapeutics announced that the first patient has been dosed in its Phase Ib/IIa (SPOTLIGHT) clinical trial evaluating subcutaneous briquilimab for the treatment of CIndU.
• In February 2024, ARS Pharmaceuticals reported positive efficacy results from its Phase II inpatient study evaluating neffy (epinephrine nasal spray), an investigational drug, for chronic spontaneous urticaria.

Urticaria Overview
Urticaria, commonly known as hives, is a skin condition characterized by the sudden appearance of red, itchy welts or wheals on the skin. These welts can vary in size and shape, often merging together to form larger areas of raised skin. Urticaria can be acute, lasting less than six weeks, or chronic, persisting for more than six weeks.

Get a Free Sample PDF Report to know more about Urticaria Pipeline Therapeutic Assessment-
https://www.delveinsight.com/report-store/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Emerging Urticaria Drugs Under Different Phases of Clinical Development Include:
• Ligelizumab: Novartis
• Remibrutinib (LOU064): Novartis
• Tezepelumab: Amgen
• CDX-0159: Celldex Therapeutics
• GI-301: GI Innovation
• Dupilumab (DUPIXENT): Sanofi/ Regeneron
• UB-221: United BioPharma
• MTPS9579A: Genentech
• Lirentelimab (AK002): Allakos Inc.
• TAS5315: Taiho Pharma
• rilzabrutinib: Sanofi
• GDC-0853: Genentech, Inc.
• AZD1981: AstraZeneca
• Desloratadine: Organon and Co

Urticaria Route of Administration
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
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Urticaria Molecule Type
Urticaria Products have been categorized under various Molecule types, such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Urticaria Pipeline Therapeutics Assessment
• Urticaria Assessment by Product Type
• Urticaria By Stage and Product Type
• Urticaria Assessment by Route of Administration
• Urticaria By Stage and Route of Administration
• Urticaria Assessment by Molecule Type
• Urticaria by Stage and Molecule Type

DelveInsight's Urticaria Report covers around 25+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Urticaria product details are provided in the report. Download the Urticaria pipeline report to learn more about the emerging Urticaria therapies
https://www.delveinsight.com/sample-request/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Urticaria Therapeutics Market include:
Key companies developing therapies for Urticaria are - Sanofi, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, Roche, Novartis, GlaxoSmithKline, Allakos, Eli Lilly and Company and others.

Urticaria Pipeline Analysis:
The Urticaria pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of 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 Urticaria Treatment.
• Urticaria key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• 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 Urticaria market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Urticaria drugs and therapies
https://www.delveinsight.com/sample-request/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Urticaria Pipeline Market Drivers
• Treatment Side Effects with Currently Available Treatment, Economic Burden on Patients, Increase in Research and Development Activities, Increasing Market Size, are some of the important factors that are fueling the Urticaria Market.

Urticaria Pipeline Market Barriers
• However, Lack of Understanding of Disease Pathology, Approaching Patent Cliff, and other factors are creating obstacles in the Urticaria Market growth.

Scope of Urticaria Pipeline Drug Insight
• Coverage: Global
• Key Urticaria Companies: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, Regeneron, GlaxoSmithKline, Taiho Pharma, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, and others
• Key Urticaria Therapies: Ligelizumab, Remibrutinib (LOU064), Tezepelumab, CDX-0159, GI-301, Dupilumab (DUPIXENT), UB-221, MTPS9579A, Lirentelimab (AK002), TAS5315, rilzabrutinib, GDC-0853, AZD1981, Desloratadine, and others
• Urticaria Therapeutic Assessment: Urticaria current marketed and Urticaria emerging therapies
• Urticaria Market Dynamics: Urticaria market drivers and Urticaria market barriers

Request for Sample PDF Report for Urticaria Pipeline Assessment and clinical trials
https://www.delveinsight.com/sample-request/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

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

Related Reports:

Urticaria Epidemiology https://www.delveinsight.com/report-store/urticaria-epidemiology-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
DelveInsight's 'Urticaria Epidemiology Forecast to 2034' report delivers an in-depth understanding of the disease, historical and forecasted Cholangiocarcinoma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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