Urticaria Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "Urticaria Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the urticaria market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging urticaria drugs, the urticaria pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The urticaria space is entering an exciting era of innovative treatment development, with leading companies such as Regeneron Pharmaceuticals, Taiho Pharmaceutical Co., Ltd, Allakos Inc, Yuhan Corporation, an d United BioPharma designing therapies to target the underlying causes of chronic hives. These groundbreaking treatments aim to block the key inflammatory pathways driving the condition, offering new hope for patients struggling with this persistent and often debilitating disease. With these advancements, the therapeutic landscape for urticaria is poised for transformation.

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Key Takeaways from the Urticaria Pipeline Report
• DelveInsight's urticaria pipeline analysis depicts a robust space with 20+ active players working to develop 25+ pipeline drugs for Urticaria treatment.
• The leading urticaria companies include Regeneron Pharmaceuticals, Taiho Pharmaceutical Co., Ltd, Allakos Inc, Yuhan Corporation, United BioPharma, Hangzhou Highlightll Pharmaceutical Co., Ltd, Kiniksa Pharmaceuticals, Ltd., Celldex Therapeutics, Longbio Pharma, Celltrion, Enanta Pharmaceuticals, and others are evaluating their lead assets to improve the urticaria treatment landscape.
• Key urticaria pipeline therapies in various stages of development include Dupilumab, TAS5315, AK006, YH35324, UB-221, TLL-018, KPL-716, AK002, CDX-0159, LP-003, CT-P39, Research programme: Chronic urticaria therapeutics, and others.
• In March 2025, Celltrion announced that the FDA approved OMLYCLO® (omalizumab-igec) as the first interchangeable biosimilar to XOLAIR® (omalizumab) for treating moderate to severe asthma, CRSwNP, IgE-mediated food allergies, and CSU.
• In November 2024, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for DUPIXENT (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.
• In Sept 2024, Sanofi announced that Dupixent (dupilumab) met key endpoints in the LIBERTY-CUPID Study C Phase 3 trial for biologic-naïve chronic spontaneous urticaria (CSU) patients on antihistamines. This confirms findings from Study A, which led to Dupixent's approval in Japan for CSU earlier this year.

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Urticaria Overview
Urticaria, commonly referred to as hives, is a skin condition marked by the sudden emergence of raised, itchy welts (also known as wheals) on the skin. These welts can range in size from small spots to large patches and may appear anywhere on the body. Affecting up to 20% of individuals at some point in their lives, urticaria is a relatively common condition. It can be classified as acute, lasting less than six weeks, or chronic, persisting for six weeks or longer.

Allergic reactions often trigger acute urticaria, while chronic forms are more complex and difficult to diagnose and manage due to their long-term and sometimes idiopathic nature. The hallmark symptom is the appearance of red, pink, or flesh-toned welts, frequently surrounded by a red halo. These lesions can shift location-disappearing in one area and reappearing in another within hours-and may vary significantly in shape and size.

Itching is the most common complaint, often accompanied by a burning or stinging sensation. In more severe cases, urticaria may lead to angioedema-deeper swelling beneath the skin-particularly around sensitive areas such as the eyes, lips, or genitals. When accompanied by symptoms like difficulty breathing or swallowing, the condition becomes a medical emergency requiring prompt intervention.

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Urticaria Treatment Analysis: Drug Profile
Dupilumab: Regeneron Pharmaceuticals
Dupilumab (Dupixent), developed by Regeneron using its VelocImmune® technology in collaboration with Sanofi, is a fully human monoclonal antibody that blocks IL-4 and IL-13 signaling-key drivers of type 2 inflammation. It is approved globally for several inflammatory conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), and prurigo nodularis. With over 750,000 patients treated worldwide, Dupilumab is now in Phase III development for chronic urticaria.

TAS5315: Taiho Pharmaceutical Co., Ltd
TAS5315 is an oral BTK inhibitor under development by Taiho Pharmaceutical for multiple inflammatory conditions, including rheumatoid arthritis and chronic spontaneous urticaria. It is currently being evaluated in Phase II clinical trials for urticaria.

Key Urticaria Therapies and Companies
• Dupilumab: Regeneron Pharmaceuticals
• TAS5315: Taiho Pharmaceutical Co., Ltd
• AK006: Allakos Inc.
• Remibrutinib (LOU064): Novartis Pharmaceuticals
• DUPIXENT (dupilumab): Sanofi/Regeneron
• FASENRA (benralizumab): AstraZeneca/Kyowa Hakko Kirin
• Lirentelimab (AK002): Allakos/BioWa
• Rilzabrutinib (SAR444671): Sanofi
• Barzolvolimab (CDX-0159): Celldex Therapeutics
• TAS5315: Taiho Pharmaceutical

Learn more about the novel and emerging urticaria pipeline therapies @ https://www.delveinsight.com/sample-request/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Urticaria Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Urticaria Pipeline Report
• Coverage: Global
• Key Urticaria Companies: Regeneron Pharmaceuticals, Taiho Pharmaceutical Co., Ltd, Allakos Inc, Yuhan Corporation, United BioPharma, Hangzhou Highlightll Pharmaceutical Co., Ltd, Kiniksa Pharmaceuticals, Ltd., Celldex Therapeutics, Longbio Pharma, Celltrion, Enanta Pharmaceuticals, and others.
• Key Urticaria Pipeline Therapies: Dupilumab, TAS5315, AK006, YH35324, UB-221, TLL-018, KPL-716, AK002, CDX-0159, LP-003, CT-P39, Research programme: Chronic urticaria therapeutics, and others.

Dive deep into rich insights for drugs used for urticaria treatment; visit @ https://www.delveinsight.com/sample-request/urticaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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

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