Chronic Spontaneous Urticaria Pipeline

DelveInsight reports that over 20 key companies are actively engaged in developing more than 20 therapies for the treatment of chronic spontaneous urticaria.

Chronic Spontaneous Urticaria Overview:

Urticaria, commonly referred to as hives, wheals, or nettle rash, presents as itchy, red, swollen welts on the skin. Chronic Spontaneous Urticaria (CSU) is defined as hives lasting for six weeks or longer and appearing on most days, often accompanied by angioedema. These symptoms can occur anywhere on the body and are generally widespread.

Diagnosis is typically based on a history of daily or recurring wheals that resolve within 24 hours but persist over a period exceeding six weeks, with no identifiable physical triggers. According to international guidelines, diagnostic testing should be limited to a differential blood count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) to exclude other conditions.

Treatment options for CSU primarily include antihistamines, omalizumab, cyclosporine, and low-dose corticosteroids.

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“Chronic Spontaneous Urticaria Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Chronic Spontaneous Urticaria Therapeutics Market.

Key Takeaways from the Chronic Spontaneous Urticaria Pipeline Report

• DelveInsight’s report on the Chronic Spontaneous Urticaria (CSU) pipeline highlights a strong competitive landscape, with over 20 active companies engaged in developing more than 20 therapies for CSU treatment.

• Key players in this space include United BioPharma, Teva Pharmaceuticals Development, Inc., Amgen, Novartis Pharmaceuticals, Allakos Inc., Sanofi, Celltrion, Celldex Therapeutics, MICROBIO GROUP, Escient Pharmaceuticals, Jasper Therapeutics, Glenmark Pharmaceuticals, Taiho Pharmaceuticals, ValenzaBio, Carna Biosciences, Servier, and others. These companies are advancing various drug candidates to enhance the current treatment options for CSU.

• Notable therapies in the pipeline include Dupilumab, Tezepelumab, Barzolvolimab, and others, currently at different stages of development.

• In February 2025, Allakos announced the termination of its AK006 program for chronic hives after a 14-week trial with 34 patients failed to show meaningful improvement over placebo. This outcome prompted the company to lay off about 75% of its workforce and consider strategic options, including mergers or partnerships.

• In November 2025, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for treating adults and adolescents aged 12 and older with CSU inadequately controlled by H1 antihistamines. The submission was backed by positive results from the LIBERTY-CUPID Phase 3 program, particularly Study C, which demonstrated significant reductions in itch and hive severity from baseline. The FDA’s target action date for the application is April 18, 2025.

Chronic Spontaneous Urticaria Pipeline Analysis

The report provides insights into:

• The report provides detailed insights into the key companies that are developing therapies in the Chronic Spontaneous Urticaria Market.

• The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Chronic Spontaneous Urticaria treatment.

• It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• It navigates the emerging 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 Chronic Spontaneous Urticaria market.

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Chronic Spontaneous Urticaria Emerging Drugs

• Dupilumab: Sanofi

• Tezepelumab: Amgen

• Barzolvolimab: Celldex Therapeutics

Chronic Spontaneous Urticaria Companies

Over 20 major companies are actively working on therapies for Chronic Spontaneous Urticaria, with Sanofi leading the field, having a drug candidate in the most advanced stage—currently in the preregistration phase.

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

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

Chronic Spontaneous Urticaria Products have been categorized under various Molecule types such as

• Monoclonal antibody

• Small molecule

• Peptide

Download Sample Pages to Get an in-depth Assessment of the Emerging Chronic Spontaneous Urticaria Therapies and Key Companies: Chronic Spontaneous Urticaria Clinical Trials and advancements

Chronic Spontaneous Urticaria Pipeline Therapeutic Assessment

• Chronic Spontaneous Urticaria Assessment by Product Type

• Chronic Spontaneous Urticaria By Stage

• Chronic Spontaneous Urticaria Assessment by Route of Administration

• Chronic Spontaneous Urticaria Assessment by Molecule Type

Download Chronic Spontaneous Urticaria Sample report to know in detail about the Chronic Spontaneous Urticaria treatment market @ Chronic Spontaneous Urticaria Therapeutic Assessment

Table of Content

1. Report Introduction

2. Executive Summary

3. Chronic Spontaneous Urticaria Current Treatment Patterns

4. Chronic Spontaneous Urticaria – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

6. Chronic Spontaneous Urticaria Late-Stage Products (Phase-III)

7. Chronic Spontaneous Urticaria Mid-Stage Products (Phase-II)

8. Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Products

11. Dormant Products

12. Chronic Spontaneous Urticaria Discontinued Products

13. Chronic Spontaneous Urticaria Product Profiles

14. Chronic Spontaneous Urticaria Key Companies

15. Chronic Spontaneous Urticaria Key Products

16. Dormant and Discontinued Products

17. Chronic Spontaneous Urticaria Unmet Needs

18. Chronic Spontaneous Urticaria Future Perspectives

19. Chronic Spontaneous Urticaria Analyst Review

20. Appendix

21. Report Methodology

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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