Chronic Idiopathic Urticaria- Pipeline Insight, 2025

DelveInsight’s, “Chronic Idiopathic Urticaria- Pipeline Insight, 2025” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Chronic Idiopathic Urticaria pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Chronic Idiopathic Urticaria: Understanding

Chronic Idiopathic Urticaria: Overview

Chronic Urticaria (CU) conventionally refers to recurrent wheals, on most days of the week that occur for a period of ≥ six weeks. CU can be further divided into two different subtypes, namely, chronic idiopathic urticaria (also called chronic spontaneous urticaria) and chronic inducible urticaria (also called physical urticaria). In most patients, CU is a sporadic and self-limited disorder. Chronic spontaneous urticaria (CSU) refers to chronic urticaria that has no specific cause or trigger. Weals are present on most days of the week for 6 weeks or more. Chronic spontaneous urticaria was previously referred to as chronic idiopathic urticaria. This term is no longer used as many cases have an autoimmune basis.

The etiology of CSU has yet to be fully established. The prevailing hypothesis is that it relates to autoimmune dysfunction involving autoantibodies targeting IgE and/or IgE receptors to activate histamine release from basophils and mast cells. Up to 40% of patients with CSU demonstrate a positive autologous serum skin test (ASST), whereby the patient’s serum injected into the dermis can induce urticaria. One-third of patients with CSU also have a positive basophil histamine release assay (BHRA), which tests for anti-FceRIa (an IgE receptor) or anti-IgE autoantibodies in the serum.

Wheals and angioedema in CSU appear to involve the degranulation of skin mast cells, which release histamine, proteases, and cytokines with the generation of platelet-activating factor and other arachidonic acid metabolites (prostaglandin D2, leukotrienes C4, D4, and E4). These mediators induce vasodilatation, increase vascular permeability, and stimulate sensory nerve endings that lead to swelling, redness, and itch. A lesion site or wheal is characterized by edema, mast cell degranulation, and a perivascular infiltrate of cells—CD4+ lymphocytes, monocytes, neutrophils, eosinophils, and basophils and has similarities to the infiltrate seen in the allergen late phase reaction. The lesion cytokine profile shows T cell expression of IL-4, IL-5, and gamma interferon suggesting a mixed Th1/Th2 response. Epithelial derived cytokines that favor the Th2 profile including IL-33, IL-25, and TSLP are detected in the dermis of lesional skin along with the vasoactive agents VEGF and CGRP, but these factors were not observed in uninvolved skin. Although several theories exist regarding the pathogenesis of chronic urticaria, none have been conclusively established. Additional theories include abnormalities of tissue mast cells and basophils as well as other serologic factors.

""Chronic Idiopathic Urticaria- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chronic Idiopathic Urticaria pipeline landscape is provided which includes the disease overview and Chronic Idiopathic Urticaria treatment guidelines. The assessment part of the report embraces, in depth Chronic Idiopathic Urticaria commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Chronic Idiopathic Urticaria collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Idiopathic Urticaria R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Idiopathic Urticaria.

Chronic Idiopathic Urticaria Emerging Drugs Chapters

This segment of the Chronic Idiopathic Urticaria report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Chronic Idiopathic Urticaria Emerging Drugs

• CMAB007: Taizhou Mabtech Pharmaceutical Co. Ltd.

CMAB007 is a recombinant, humanized anti-IgE monoclonal antibody developed by Taizhou Mabtech Pharmaceutical, a subsidiary of MabPharm. The mechanism of action of CMAB007 is that it combines with free IgE to form an anti-IgE complex, which inhibits the high affinity IgE receptor and thereby prevents the allergic response. The company is currently conducting a Phase III clinical trial for CMAB007, a biosimilar of omalizumab, in patients with chronic spontaneous urticaria. The trial is a multicenter, randomized, double-blind, positive parallel controlled study comparing the efficacy, immunogenicity, pharmacokinetics, pharmacodynamics, and safety of CMAB007 and Xolair in these patients.

• Barzolvolimab: Celldex Therapeutics

Barzolvolimab (CDX-0159) is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival, and activity of mast cells. In certain inflammatory diseases, mast cell activation plays a central role in the onset and progression of the disease. Currently, the drug is being evaluated in the Phase III development stage for the treatment of chronic spontaneous urticaria..

• AK006: Allakos

AK006 is a humanized IgG1 monoclonal antibody that activates the inhibitory receptor Siglec-6, which is selectively expressed on mast cells. In preclinical studies, AK006 has demonstrated the ability to inhibit multiple modes of mast cell activation, including IgE, IL-33, KIT, C5a, and MRGPRX2, resulting in broad suppression of inflammation. Additionally, AK006 has been shown to reduce human tissue mast cells via antibody-dependent cellular phagocytosis (ADCP). Allakos is currently evaluating AK006 in a Phase I clinical trial in patients with chronic spontaneous urticaria (CSU), a condition where inappropriate activation of mast cells in the skin leads to symptoms. The Phase I trial is a randomized, double-blind, placebo-controlled study that will assess the safety, tolerability, pharmacokinetics, and efficacy of AK006 in CSU patients.

Further product details are provided in the report……..

Chronic Idiopathic Urticaria: Therapeutic Assessment

This segment of the report provides insights about the different Chronic Idiopathic Urticaria drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Chronic Idiopathic Urticaria
• There are approx. 15+ key companies which are developing the therapies for Chronic Idiopathic Urticaria. The companies which have their Chronic Idiopathic Urticaria drug candidates in the most advanced stage, i.e. Phase III include, Taizhou Mabtech Pharmaceutical.
• Phases

DelveInsight’s report covers around 20+ products under different phases of clinical development like

• 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
• Route of Administration

Chronic Idiopathic 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
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chronic Idiopathic Urticaria: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Idiopathic Urticaria therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chronic Idiopathic Urticaria drugs.

Chronic Idiopathic Urticaria Report Insights

• Chronic Idiopathic Urticaria Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Chronic Idiopathic Urticaria Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Chronic Idiopathic Urticaria drugs?
• How many Chronic Idiopathic Urticaria drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Idiopathic Urticaria?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Chronic Idiopathic Urticaria therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Chronic Idiopathic Urticaria and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• United BioPharma
• Teva Pharmaceuticals Development, Inc.
• Amgen
• Novartis Pharmaceuticals
• Allakos Inc.
• Sanofi
• Celltrion
• Celldex Therapeutics

Key Products

• LOU064
• Dupilumab
• Barzolvolimab
• UB221
• Lirentelimab
• CT-P39
• Tezepelumab
• TEV-45779

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