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

Curious about the latest updates in the Urticaria Pipeline? Click here to explore the therapies and trials making headlines @ Urticaria Pipeline Outlook Report

Key Takeaways from the Urticaria Pipeline Report

• On 07 October 2025, Teva Pharmaceuticals USA conducted 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. announced 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).
• On 01 October 2025, Evommune Inc . organized a study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).
• On 01 October 2025, Celldex Therapeutics initiated a study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
• On 01 October 2025, Novartis Pharmaceuticals conducted a Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
• DelveInsight's Urticaria Pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Urticaria treatment.
• The leading Urticaria Companies such as 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.
• Promising Urticaria Pipeline Therapies such as Xolair® (Omalizumab), ARS-1, Desloratadine, GDC-0853, Omalizumab, Abatacept (Orencia ®), Bilastine, Levocetirizine, levocetirizine dihydrochloride, Quilizumab, cetirizine and others.

Want to know which companies are leading innovation in Urticaria? Dive into the full pipeline insights @ Urticaria Clinical Trials Assessment

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

Urticaria Overview

Urticaria, commonly known as hives, is a skin condition characterized by the sudden appearance of raised, itchy welts (wheals) on the skin. These welts can vary in size, from small spots to large patches, and can appear anywhere on the body. Urticaria is a common condition, affecting up to 20% of people at some point in their lives. The condition can be acute, lasting less than six weeks, or chronic, lasting longer than six weeks. While acute urticaria is often triggered by allergic reactions, chronic urticaria can be more challenging to diagnose and treat due to its persistent nature.

Urticaria Emerging Drugs Profile

• Dupilumab: Regeneron Pharmaceuticals

Dupilumab (Dupixent), which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupilumab is been developed in collaboration with Sanofi. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase III trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and EoE. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 750,000 patients are being treated with Dupixent globally. Currently, the drug is in Phase III stage of its development for the treatment of Urticaria.

• TAS5315: Taiho Pharmaceutical Co., Ltd

TAS5315 is a novel oral investigational drug candidate being developed by Taiho Pharmaceutical Co., Ltd. The drug candidate is a BTK inhibitor that is been developed for various indications like rheumatoid arthritis, detrusor underactivity with overactive bladder and chronic spontaneous urticarial. Currently, the drug is in Phase II stage of its development for the treatment of Urticaria.

• AK006: Allakos Inc.

AK006 is a humanized IgG1 monoclonal antibody which activates the inhibitory receptor Siglec-6. AK006 is directed to an extracellular epitope of the Siglec-6 receptor that was identified for its ability to generate strong inhibitory signals to mast cells. Furthermore, AK006 was engineered to have higher cell surface residence time which may increase mast cell inhibition. In addition to inhibition, in preclinical studies AK006 reduces mast cell numbers via antibody-dependent cellular phagocytosis (ADCP) in the presence of activated macrophages. In vitro and in vivo studies have demonstrated AK006 inhibits multiple modes of mast cell activation including IgE, IL-33, KIT, C5a, and MRGPRX2, resulting in the broad suppression of inflammation. In preclinical studies, AK006 displays significantly stronger mast cell inhibition than AK002. Currently, the drug is in Phase I stage of its development for the treatment of Urticaria.

If you're tracking ongoing Urticaria Clinical trials, this press release is a must-read. Tap to see the breakthroughs @ Urticaria Treatment Drugs

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 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.

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.

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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Urticaria Products have been categorized under various Molecule types such as

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

From emerging drug candidates to competitive intelligence, the Urticaria Pipeline Report covers it all – check it out now @ Urticaria Market Drivers and Barriers, and Future Perspectives

Scope of the Urticaria Pipeline Report

• Coverage- Global
• 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.
• Urticaria Pipeline Therapies- Xolair® (Omalizumab), ARS-1, Desloratadine, GDC-0853, Omalizumab, Abatacept (Orencia ®), Bilastine, Levocetirizine, levocetirizine dihydrochloride, Quilizumab, cetirizine and others.
• Urticaria Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Urticaria Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Stay ahead in Healthcare Research – discover what's next for the Urticaria Treatment landscape in this detailed analysis @ Urticaria Emerging Drugs and Major Players

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