Chronic Spontaneous Urticaria - Pipeline Insight, 2025

This “Chronic Spontaneous Urticaria - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Chronic Spontaneous 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.

Chronic Spontaneous Urticaria: Understanding

Chronic Spontaneous Urticaria: Overview

Chronic Spontaneous Urticaria (CSU) is defined as hives that are present for at least or greater than 6 weeks and for the most days of the week. Chronic spontaneous urticaria is characterized by the presence of weals and angioedema. Weals can affect any site on the body and tend to be distributed widely. Chronic urticaria is diagnosed is based on a history lasting over 6 weeks of daily or episodic weals that last less than 24 hours without the presence of physical trigger factors. The international guidelines recommend limiting investigations in most patients with chronic spontaneous urticaria to differential blood count and erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Medicines for the treatment of chronic spontaneous urticarial are antihistamines, omalizumab, cyclosporine, and low-dose corticosteroids.

Chronic Spontaneous Urticaria (CSU), also known as chronic idiopathic urticaria, often occurs without a clear external trigger. It is thought to involve autoimmune mechanisms, where the body’s immune system mistakenly activates mast cells, releasing histamine and other inflammatory mediators. In some cases, it may be associated with underlying conditions like autoimmune thyroid disease, infections, or stress, but many cases remain idiopathic. Symptoms of chronic idiopathic urticaria include raised or swollen welts on your skin (hives or wheals) that appear and reappear over the course of 6 weeks. Itching that is sometimes severe. Swelling of the lips, eyelids, or throat (angioedema).

Wheals and angioedema in CSU appear to involve the degranulation of skin mast cells, which release histamine, proteases and cytokines with 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.

In an otherwise health individual, very few tests need to be done for a proper evaluation. Skin testing for food allergy is not recommended. The typical patient who suspects a food allergy as the cause may present with a lengthy list of suspected foods or has tried many different diets manipulations, none of which have made a consistent difference in clinical course. Laboratory tests are also kept to a minimum. A CBC with differential is helpful if eosinophilia is seen. Then a stool for ova and parasites may be ordered. A sedimentation rate and/or CRP can help screen for autoimmune disorders, if prominently elevated, although the history and physical exam should suggest a more general problem. The primary principle of treatment of CSU is to eliminate symptoms, including pruritus, wheals and angioedema. H1 antihistamines function as inverse agonists that combine with and stabilize the inactive conformation of the H1 receptor. Omalizumab, an IgG anti-IgE injectable antibody, was approved for the treatment of antihistamine-refractory CSU for ages 12 and older in 2014. Numerous other potential therapeutics for CSU are currently under investigation. Designed ankyrin repeat proteins (DARPins) are a class of small binding proteins consisting of stacked ankyrin repeat domains capable of binding to target proteins, effectively emulating monoclonal antibodies. Specific DARPins have been identified as capable of binding human FcεRI as well as human IgE, and although these hold promise as potential future treatments, these therapies should be approached with caution given the potential for immunoreactivity.

"Chronic Spontaneous Urticaria - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chronic Spontaneous Urticaria pipeline landscape is provided which includes the disease overview and Chronic Spontaneous Urticaria treatment guidelines. The assessment part of the report embraces, in depth Chronic Spontaneous 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 Spontaneous 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 Spontaneous Urticaria R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Spontaneous Urticaria.

Chronic Spontaneous Urticaria Emerging Drugs Chapters

This segment of the Chronic Spontaneous Urticaria report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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 Spontaneous Urticaria Emerging Drugs

Remibrutinib: Novartis

Remibrutinib (LOU064) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts and swelling. In Phase II studies, remibrutinib demonstrated fast onset of action and sustained efficacy in patients with moderate to severe chronic spontaneous urticaria (CSU). Remibrutinib has been shown to be well-tolerated across all doses studied in Phase II. These results have been confirmed by the Phase III REMIX data. In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, such as multiple sclerosis, hidradenitis suppurativa, food allergy and Sjögren's syndrome. If approved, remibrutinib has the potential to become an effective oral option to complement Xolair® (omalizumab), the first and only injectable biologic indicated for CSU. Currently the drug is Registered evaluation for the treatment of Chronic Spontaneous Urticaria.

Barzolvolimab: Celldex Therapeutics

DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, Barzolvolimab (CDX-0159), developed by Celldex Therapeutics, is a humanized monoclonal antibody that selectively binds and blocks the receptor tyrosine kinase KIT, a key regulator of mast cell survival and activation, making it a targeted therapy for mast cell-driven disorders . It has shown robust efficacy in Phase 2 trials for chronic spontaneous urticaria (CSU), delivering rapid, durable symptom relief - including up to a 24-point reduction in UAS7 score by week 12 - and providing complete disease control in a high percentage of patients through week 52. Side effects have been generally mild and reversible, such as hair color changes and transient neutropenia. Celldex has launched global Phase III EMBARQ® trials in CSU and plans to expand into other indications, including chronic inducible urticaria, eosinophilic esophagitis, prurigo nodularis, and atopic dermatitis. With its potent mast cell-depleting mechanism, barzolvolimab holds promise to transform treatment across a range of chronic inflammatory and allergic conditions.

JYB1904: Jemincare

JYB1904 is a novel, half-life-extended anti-IgE monoclonal antibody developed by Shanghai Jemincare (licensed as RPT904 outside Greater China) designed to bind free IgE and prevent its interaction with FcεRI on effector cells. In a Phase 1 single-dose escalation trial in healthy volunteers, it demonstrated excellent safety (all AEs were Grade 1-2), dose-proportional pharmacokinetics, and a median half-life over twice that of omalizumab - alongside deeper and more sustained suppression of free IgE and higher total IgE accumulation. Ongoing Phase II studies in China are evaluating its PK/PD profile in allergic asthma (topline data expected late 2025) and its efficacy in chronic spontaneous urticaria (CSU). Backed by a global licensing deal with RAPT Therapeutics (excluding Greater China territories) that included a $35 million upfront payment and up to $672.5 million in milestones, JYB1904 shows promise as a longer-lasting, next-generation alternative to omalizumab for IgE-mediated allergic diseases.

YH35324: Yuhan Corporation

YH35324 is a novel, long-acting IgE-trap Fc fusion protein engineered by Yuhan Corporation to bind and neutralize free IgE via high-affinity FcεRIα interaction, preventing IgE-mediated activation of mast cells and basophils. In Phase I trials involving subcutaneous single and multiple ascending doses in atopic adults and healthy volunteers, it demonstrated a favorable safety profile - mostly grade 1/2 AEs with no serious events - and dose-proportional pharmacokinetics with prolonged IgE suppression that outperformed omalizumab, especially in individuals with high baseline IgE (>700 IU/mL) . Mechanistic studies showed it effectively reduces FcεRIα expression on basophils and mast cells and remains active through FcRn-mediated recycling. With ongoing Phase 1b studies in allergic diseases like chronic urticaria and atopic dermatitis. YH35324 offers a promising next-generation alternative to omalizumab for IgE-driven conditions.

Chronic Spontaneous Urticaria: Therapeutic Assessment

This segment of the report provides insights about the different Chronic Spontaneous Urticaria drugs segregated based on following parameters that define the scope of the report.

Major Players in Chronic Spontaneous Urticaria
There are approx. 20+ key companies which are developing the therapies for Chronic Spontaneous Urticaria. The companies which have their Chronic Spontaneous Urticaria drug candidates in the most advanced stage, i.e. Registration include, Novartis.

Phases
The 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) along with the details of:
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration
Chronic Spontaneous 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:

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type
Products have been categorized under various Molecule types, such as:

• Monoclonal antibody
• Small molecule
• Peptide

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

Chronic Spontaneous Urticaria: Pipeline Activities

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

Development Activities

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

Chronic Spontaneous Urticaria Report Insights

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

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

Key Players

• Novartis
• Hangzhou Highlightll Pharmaceutical Co., Ltd
• Celldex Therapeutics
• Jemincare
• Yuhan Corporation
• United BioPharma
• Septerna
• Recludix Pharma

Key Products

• Remibrutinib
• TLL018
• Barzolvolimab
• JYB1904
• YH35324
• UB-221
• SEP-631 (MRGPRX2)
• Brutons tyrosine kinase SH2 inhibitor program

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