Chronic Spontaneous Urticaria Pipeline Analysis

DelveInsight reports that over 20 leading companies are actively engaged in developing more than 20 treatment therapies for Chronic Spontaneous Urticaria.

Chronic Spontaneous Urticaria Overview:

Urticaria, commonly referred to as hives, wheals, or nettle rash—is marked by red, itchy, and swollen patches on the skin. Chronic Spontaneous Urticaria (CSU) is a subtype in which these hives occur almost daily and last for more than six weeks. It often involves widespread wheals and may include angioedema. Diagnosis typically relies on a clinical history of transient weals lasting less than 24 hours and without a known physical trigger. Current international guidelines suggest minimal diagnostic testing, focusing mainly on a complete blood count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels. Treatment options for CSU 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 dynamic landscape, with over 20 pharmaceutical companies actively developing more than 20 potential therapies for the condition. Leading players in this space include United BioPharma, Teva Pharmaceuticals, Amgen, Novartis, Allakos, Sanofi, Celltrion, Celldex Therapeutics, MICROBIO GROUP, Escient Pharmaceuticals, Jasper Therapeutics, Glenmark, Taiho Pharmaceuticals, ValenzaBio, Carna Biosciences, Servier, among others.

• Several promising candidates are in various stages of development, such as Dupilumab, Tezepelumab, and Barzolvolimab. In November 2024, the FDA accepted a resubmission of the supplemental Biologics License Application (sBLA) for Dupixent to treat CSU in patients aged 12 and above who are not adequately managed by H1 antihistamines. The application is backed by positive Phase 3 LIBERTY-CUPID trial data, with a regulatory decision expected by April 18, 2025.

• Meanwhile, Incyte discontinued patient enrollment in its CSU study of INCB000262 in November 2024 due to toxicology concerns found in lab tests, despite no adverse effects being observed in ongoing clinical trials. These findings were reported to the FDA and may influence future development.

• In Europe, the EMA’s Committee for Medicinal Products for Human Use recommended Omlyclo—a biosimilar of omalizumab—for approval in March 2024. It was granted marketing authorization in May 2024 for use in CSU, as well as in severe allergic asthma and chronic rhinosinusitis with nasal polyps.

• Additionally, Novartis announced in November 2023 that its BTK inhibitor remibrutinib demonstrated statistically and clinically significant improvements in urticaria activity in a Phase III trial, reinforcing its potential as an effective oral therapy for CSU.

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.

Download our free sample page report on Chronic Spontaneous Urticaria pipeline insights

Chronic Spontaneous Urticaria Emerging Drugs

• Dupilumab: Sanofi

• Tezepelumab: Amgen

• Barzolvolimab: Celldex Therapeutics

Chronic Spontaneous Urticaria Companies

Over 20 prominent companies are actively working on therapies for Chronic Spontaneous Urticaria, with Sanofi leading the way—its drug candidate is the furthest along in development, currently in the preregistration stage.

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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