Urticaria Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis

(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 September 2025, Chronic spontaneous urticaria (CSU) remains a difficult condition to treat, particularly in patients who do not respond adequately to second-generation antihistamines. A recent review in Allergy summarized phase 3 trial findings for omalizumab, dupilumab, and the Bruton tyrosine kinase (BTK) inhibitor remibrutinib, highlighting their efficacy, placebo responses, and clinical relevance. Among these, omalizumab, a humanized anti-IgE monoclonal antibody, has the most comprehensive clinical evidence in CSU. Data from the pivotal phase 3 ASTERIA I, ASTERIA II, and GLACIAL trials showed that omalizumab significantly outperformed placebo, with 34% to 44% of patients achieving complete control (UAS7 = 0) and 52% to 66% reaching partial control at week 12.
• In September 2025, Sanofi (SNY) and Regeneron (REGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of Dupixent (dupilumab) in the EU for chronic spontaneous urticaria (CSU) treatment in adults and adolescents. The recommendation targets patients aged 12 years and older with moderate-to-severe CSU who do not respond sufficiently to histamine-1 antihistamines and have not previously received anti-IgE therapy. A final regulatory decision is anticipated in the coming months.
• 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.

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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

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.

This release was published on openPR.