Chronic Urticaria Or Hives - Pipeline Insight, 2025

This “Chronic Urticaria or Hives - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Chronic Urticaria or Hives 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 Urticaria or Hives: Understanding

Chronic Urticaria or Hives: Overview

Chronic urticaria (CU) is a condition where hives or wheals appear on the skin for more than six weeks. It affects the quality of life due to persistent itching and discomfort. CU can be idiopathic (unknown cause) or associated with other underlying conditions.

Signs and symptoms of CU includes Hives (Wheals): Raised, red or skin-colored welts that can vary in size and shape, typically appearing and disappearing on different areas of the body, Itching, intense itching, which can be severe and often worsens at night, swelling in the deeper layers of the skin, particularly around the eyes, lips, and sometimes the throat, leading to discomfort and potential breathing difficulties and persistence symptoms lasting more than six weeks, with hives appearing most days of the week. The causes of chronic urticaria are often unknown, but potential triggers include Autoimmune Factors Presence of autoantibodies that activate mast cells or basophils, leading to histamine release, physical stimuli, pressure, temperature changes, sunlight, or exercise can trigger hives in some individuals, infections chronic infections, such as Helicobacter pylori or viral infections, may be associated with CU, allergens though rare in CU, some cases are linked to food, medications, or environmental allergens and underlying medical conditions like thyroid disease, rheumatoid arthritis, or lupus. Pathophysiology of Chronic urticaria involves complex interactions between immune cells and mediators mast cells and basophils these cells release histamine and other mediators that cause the symptoms of urticarial, Histamine: Leads to vasodilation, increased vascular permeability, and stimulation of sensory nerves, resulting in itching and swelling. In some patients, autoantibodies target the high-affinity IgE receptor (FcεRI) or IgE on mast cells, causing their activation. Inflammatory Cytokines like IL-4, IL-5, and IL-13 contribute to the inflammatory response seen in chronic urticaria. The diagnosis of chronic urticaria is primarily clinical, based on a thorough patient history and physical examination. Key aspects include assessing the duration and frequency of hives, identifying potential triggers, and documenting associated symptoms like angioedema. Laboratory tests such as a complete blood count (CBC), erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), thyroid function tests, and possibly autoimmune or infection markers, may be performed to rule out underlying conditions. In some cases, an autologous serum skin test (ASST) can help identify autoimmune urticaria. Diagnosis focuses on distinguishing chronic urticaria from other types of hives and identifying any contributory factors. Treatment of chronic urticaria primarily involves the use of non-sedating H1 antihistamines at standard or increased doses. If symptoms persist, second-line treatments may include H2 antihistamines or leukotriene receptor antagonists. For refractory cases, third-line options such as omalizumab (a monoclonal antibody targeting IgE) or immunosuppressants like cyclosporine may be used. Short courses of oral corticosteroids can be administered for acute exacerbations, though they are not recommended for long-term use. Identifying and avoiding known triggers is also crucial.

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

Chronic Urticaria or Hives Emerging Drugs Chapters

This segment of the Chronic Urticaria or Hives 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 Urticaria or Hives Emerging Drugs

SYN008: Synermore Biologics

SYN008 is a biosimilar of Omalizumab (Xolair; a humanized anti-immunoglobulin E monoclonal antibody). It binds to the free IgE molecules in serum, thereby blocking the interaction between IgE and effector cells, which trigger the allergic response irrespective of allergen type. Stringent comparability studies between SYN008 and Omalizumab have been conducted and the investigational new drug (IND) application of SYN008 has been filed to the China Food and Drug Administration (CFDA) in Oct 2014. The phase I clinical trial has been completed in Australia in Sep 2016. Currently, the drug is in Phase III stage of its development for the treatment of Chronic Urticaria.

Povorcitinib - Incyte Corporation

Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 3 clinical trials for hidradenitis suppurativa (HS) and vitiligo. A Phase 3 trial is being planned for prurigo nodularis (PN). Phase II studies of povorcitinib in PN, asthma and chronic spontaneous urticaria are also ongoing. Povorcitinib is a selective oral small-molecule JAK1 inhibitor, with compound and use patents in certain countries/regions in the Territory. Currently, the drug is in Phase II stage of its development for the treatment of Chronic Urticaria.

Briquilimab: Jasper Therapeutics

Briquilimab (JSP191) is an unconjugated, aglycosylated, anti-c-Kit antibody that functionally blocks the interaction of the c-Kit receptor from its ligand, stem cell factor (SCF). The interaction of SCF and c-Kit is required for mast cells to survive. By blocking SCF from binding to c-Kit and disrupting the critical survival signal, briquilimab causes mast cells to undergo orderly cell death. For mast cell-driven diseases such as chronic urticaria, this removes the underlying source of the inflammatory response. In low-to-intermediate risk MDS, briquilimab blocks critical cell survival signals, depleting Kit-expressing MDS cells. For stem cell transplant, briquilimab blocks the ability of stem cells to recover from low intensity radiation, thereby opening the specific niches in the bone marrow for donor or gene-corrected hematopoietic stem cells to engraft. Currently, the drug is in Phase I/II stage of its development for the treatment of Chronic Urticaria.

Chronic Urticaria or Hives: Therapeutic Assessment

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

Major Players in Chronic Urticaria or Hives

• There are approx. 20+ key companies which are developing the therapies for Chronic Urticaria or Hives. The companies which have their Chronic Urticaria or Hives drug candidates in the most advanced stage, i.e. phase III include, Synermore Biologics.

Phases

The report covers around 22+ 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 Urticaria or Hives 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 Urticaria or Hives: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Urticaria or Hives 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 Urticaria or Hives drugs.

Chronic Urticaria or Hives Report Insights

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

Chronic Urticaria or Hives 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 Urticaria or Hives drugs?
• How many Chronic Urticaria or Hives drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Urticaria or Hives?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Urticaria or Hives 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 Urticaria or Hives and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Synermore Biologics
• Incyte Corporation
• Jasper Therapeutics
• Novartis
• Regeneron/Sanofi
• Principia Biopharma
• Enanta Pharmaceuticals
• Granular Therapeutics
• Blueprint Medicines
• Newave Pharmaceutical

Key Products

• SYN008
• Povorcitinib
• Briquilimab
• Remibrutinib
• Dupilumab
• Rilzabrutinib
• Research programme: Chronic urticaria therapeutics
• Mast cell driven disorder therapy
• BLU 808
• Rocbrutinib

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