Chronic Idiopathic Urticaria Pipeline

DelveInsight’s, “Chronic Idiopathic Urticaria (CIU) - Pipeline Insight, 2025” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Chronic Idiopathic Urticaria (CIU) 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 (CIU): Understanding

Chronic Idiopathic Urticaria (CIU): Overview

Chronic Idiopathic Urticaria (CIU), also known as Chronic Spontaneous Urticaria (CSU), is a mast cell-mediated skin condition marked by the spontaneous and recurrent appearance of wheals (hives), angioedema, or both, lasting six weeks or longer without a known external trigger. It significantly affects quality of life due to persistent itching, discomfort, and sleep disturbances. The exact cause remains unclear, though autoimmune mechanisms are suspected in many cases. CIU is diagnosed clinically and often requires exclusion of other underlying conditions. Management typically involves second-generation antihistamines, with biologic therapies considered in resistant cases.

 

Chronic Idiopathic Urticaria (CIU) presents primarily with hives (urticaria)—raised, itchy, red or skin-colored welts that can appear anywhere on the body—and angioedema, which is swelling in the deeper layers of the skin, commonly around the eyes, lips, hands, or throat. The itchiness associated with CIU can be intense, persistent, and significantly impact daily functioning. While the condition primarily affects the skin, some individuals may also experience systemic symptoms such as fatigue, headaches, joint pain, or gastrointestinal discomfort, further contributing to its burden on quality of life. Symptoms often fluctuate in severity and may occur daily or intermittently without warning. Emotional stress, heat, or pressure on the skin can sometimes exacerbate the symptoms, although no clear external trigger is typically identified.

 

The pathophysiology of Chronic Spontaneous Urticaria (CSU), also referred to as Chronic Idiopathic Urticaria (CIU), involves the activation and degranulation of mast cells and basophils, leading to the release of various immune mediators. Histamine, the primary mediator, binds to H-receptors on endothelial cells and sensory nerves, resulting in vasodilation, increased vascular permeability, and dermal edema, along with recruitment of inflammatory cells. Other mediators such as prostaglandins, leukotrienes, cytokines, and chemokines also contribute to the inflammatory response. Mast cell activation may occur through immunological mechanisms—including IgG-mediated autoimmunity (type II hypersensitivity), immune complex deposition (type III), or T-cell involvement (type IV)—even in the absence of allergen-specific IgE, which distinguishes CSU from classical type I hypersensitivity reactions. Non-immunological triggers such as pressure, temperature changes, or certain drugs can also activate mast cells independently of adaptive immunity, possibly due to a lowered activation threshold in affected individuals. 

 

The management of Chronic Spontaneous Urticaria (CSU) focuses on avoiding known exacerbating factors and effectively controlling symptoms throughout the disease course. First-line pharmacological treatment involves regular use of second-generation H1-antihistamines such as cetirizine, loratadine, or fexofenadine, which may be up-titrated to four times the standard dose if symptoms persist. First-generation antihistamines are generally avoided due to their sedative and anticholinergic side effects. For patients with CSU unresponsive to antihistamines, omalizumab, a monoclonal anti-IgE antibody administered subcutaneously at 300 mg every four weeks, serves as an effective second-line therapy. Ciclosporin may be used as a third-line agent in refractory cases, though its use is off-label and requires careful monitoring due to potential nephrotoxicity and hypertension. Short courses of systemic corticosteroids can be used for acute flares, while topical corticosteroids are ineffective. Although evidence is limited, other therapies such as leukotriene antagonists, dapsone, methotrexate, and phototherapy may be considered in select, treatment-resistant cases.

 

"Chronic Idiopathic Urticaria (CIU)- 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 (CIU) pipeline landscape is provided which includes the disease overview and Chronic Idiopathic Urticaria (CIU) treatment guidelines. The assessment part of the report embraces, in depth Chronic Idiopathic Urticaria (CIU) 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 (CIU) 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 (CIU) R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Idiopathic Urticaria (CIU).

 

Chronic Idiopathic Urticaria (CIU) Emerging Drugs Chapters

This segment of the Chronic Idiopathic Urticaria (CIU) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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 (CIU) Emerging Drugs

• ADL018: Kashiv BioSciences, LLC

ADL018 is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® (omalizumab), an injectable prescription medicine approved to treat chronic spontaneous urticaria (CSU) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. ADL018 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as United States and European Union (EU)-approved omalizumab. Currently, the drug is registered for the treatment of Chronic Idiopathic Urticaria (CIU) as the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated and accepted its Marketing Authorization Application (MAA).

 

• Remibrutinib: Novartis Pharmaceuticals

Remibrutinib is an investigational, highly selective, covalent, oral BTK inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itchy hives (wheals) and swelling. When remibrutinib is used alongside standard-dose antihistamines, it results in a “two-pronged approach” where two parts of the inflammatory pathway are targeted, with remibrutinib inhibiting histamine release and antihistamines inhibiting histamine receptors, reducing CSU symptoms. Treatment with remibrutinib in clinical trials showed significant symptom improvement early, which was sustained. Remibrutinib has been shown to be well-tolerated, with a favorable safety profile up to 52 weeks, including balanced liver function tests versus placebo. Currently, the drug is in Phase III stage of its development for the treatment of Chronic Idiopathic Urticaria (CIU).

 

• JYB1904: Jemincare

JYB1904/RPT904 is a novel, half-life extended anti-IgE monoclonal antibody (mAb) for the treatment of patients with food allergies, chronic spontaneous urticaria and other allergic inflammatory diseases. RPT904 is designed to bind free human immunoglobulin E (IgE), a key driver of allergic diseases, and in early clinical studies has demonstrated more than twice the half-life, as well as extended pharmacokinetics and pharmacodynamic properties, compared to omalizumab (Xolair®), a first generation anti-IgE mAb. Currently, the drug is in Phase II stage of its development for the treatment of Chronic Idiopathic Urticaria (CIU).

 

• EVO756: Evommune, Inc.

EVO756 is a small molecule antagonist of MRGPRX2 that is being developed as a first-in-class, best-in-class oral treatment for mast cellmediated diseases including Chronic Spontaneous Urticaria (CSU) and atopic dermatitis (AD), with additional possible applications in neuroinflammation. MRGPRX2, is a G-Protein-Coupled-Receptor (GPCR) found on mast cells (MC) and sensory neurons. It facilitates potent degranulation in MCs, and on sensory neurons, driving neurogenic inflammation and sensations such as cough, pain, and itch. The receptor is activated by a broad spectrum of ligands that are prevalent during inflammation. Targeting MRGPRX2 may have potential across an array of MC-mediated diseases and in mitigating neurogenic inflammation. Currently, the drug is in Phase II stage of its development for the treatment of Chronic Idiopathic Urticaria (CIU).

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

 

Chronic Idiopathic Urticaria (CIU): Therapeutic Assessment

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

Major  Players in Chronic Idiopathic Urticaria (CIU)

There are approx. 15+ key companies which are developing the therapies for Chronic Idiopathic Urticaria (CIU). The companies which have their Chronic Idiopathic Urticaria (CIU) drug candidates in the most advanced stage, i.e. Registration include, Kashiv BioSciences, LLC.

 

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 (CIU) 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 (CIU): Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Chronic Idiopathic Urticaria (CIU) 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 (CIU) drugs.

 

Chronic Idiopathic Urticaria (CIU) Report Insights

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

 

Chronic Idiopathic Urticaria (CIU) 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 (CIU) drugs?
• How many Chronic Idiopathic Urticaria (CIU) 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 (CIU)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Chronic Idiopathic Urticaria (CIU) 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 (CIU) and their status?
• What are the key designations that have been granted to the emerging drugs?