Chronic Urticaria or Hives Pipeline Analysis, 2025 by DelveInsight | Novartis, Synermore Biologics, Teva Pharmaceuticals, Regeneron Pharmaceuticals, Celltrion, United BioPharma, Glenmark Pharmaceutica

DelveInsight's, "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.
DelveInsight reports that over 20 leading companies are actively advancing more than 22 therapies in the Chronic Urticaria (Hives) treatment pipeline.

DelveInsight's "Chronic Urticaria or Hives - Pipeline Insight, 2025 [https://www.delveinsight.com/report-store/chronic-urticaria-or-hives-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr]" offers a concise overview of the current pipeline landscape and future growth potential in Chronic Urticaria or Hives. The report covers disease background, treatment guidelines, and a comprehensive analysis of pipeline candidates, including their mechanisms, clinical progress, and development updates such as collaborations, funding, and designations.

Key Takeaways from the Chronic Urticaria or Hives Pipeline Report:

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DelveInsight's analysis of the Chronic Urticaria (Hives) pipeline reveals a strong and evolving landscape, with over 20 active companies advancing more than 22 investigational therapies at different clinical stages.

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A major milestone was reached on April 18, 2025, when the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab), developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who remain uncontrolled on H1 antihistamines. This marks the first targeted therapy for CSU in more than a decade, offering new hope to an estimated 300,000 U.S. patients affected by the condition.

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This approval follows the FDA's earlier rejection of Dupixent in 2023, which cited the need for additional efficacy evidence. The resubmission included pivotal new data demonstrating the drug's effectiveness, ultimately leading to its approval.

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Key industry players driving innovation in the CSU treatment space include Novartis, Synermore Biologics, Teva Pharmaceuticals, Regeneron Pharmaceuticals, Celltrion, United BioPharma, Glenmark Pharmaceuticals, UCB Biopharma, GI Innovation, Celldex Therapeutics, Eli Lilly, Amgen, ValenzaBio, Third Harmonic Bio, Inmagene, Lanier Biotherapeutics, among others.

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Promising therapies under development, such as SYN008, Povorcitinib, Briquilimab, and additional candidates, are expected to further expand treatment options and reshape the Chronic Urticaria landscape.

Chronic Urticaria or Hives Overview

Chronic urticaria (CU) is a skin disorder characterized by recurring hives or welts that persist for more than six weeks, often causing continuous itching and discomfort that can greatly impact quality of life. The condition may occur without an identifiable cause (idiopathic) or be associated with underlying medical conditions.

Uncover the latest breakthroughs in Chronic Urticaria or Hives therapeutics, download our report @ https://www.delveinsight.com/report-store/chronic-urticaria-or-hives-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Chronic Urticaria or Hives Pipeline Analysis

The Chronic Urticaria or Hives pipeline insights report 2025 provides insights into:

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Provides comprehensive insights into key companies developing therapies in the Chronic Urticaria or Hives Market.

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Categorizes Chronic Urticaria or Hives therapeutic companies by development stage: early, mid, and late-stage.

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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.

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Reviews emerging Chronic Urticaria or Hives drugs under development based on:

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Stage of development

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Chronic Urticaria or Hives Route of Administration

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Target receptor

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Monotherapy vs. combination therapy

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Chronic Urticaria or Hives Mechanism of Action

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Molecular type

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Offers detailed analysis of:

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Company-to-company and company-academia collaborations

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Chronic Urticaria or Hives Licensing Agreements

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Funding and investment activities that support future advancements in the Chronic Urticaria or Hives market.

Get Full Insights into the Chronic Urticaria or Hives Pipeline and Future Market Trends - Download the Report Now: https://www.delveinsight.com/sample-request/chronic-urticaria-or-hives-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Chronic Urticaria or Hives Emerging Drugs

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SYN008: Synermore Biologics

SYN008 is a biosimilar to Omalizumab (Xolair), a humanized monoclonal antibody that targets immunoglobulin E (IgE). By binding to circulating IgE, it prevents interaction with immune effector cells responsible for triggering allergic responses, irrespective of the allergen. Extensive comparability studies have been conducted to confirm its similarity to the reference drug. An Investigational New Drug (IND) application for SYN008 was filed with the China Food and Drug Administration (CFDA) in October 2014, followed by a successful Phase I trial in Australia in September 2016. The therapy is currently undergoing Phase III clinical development for the treatment of chronic urticaria.

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Povorcitinib: Incyte Corporation

Povorcitinib (INCB54707) is an oral small-molecule inhibitor that selectively blocks JAK1. It is in Phase III clinical trials for hidradenitis suppurativa (HS) and vitiligo, with a Phase III study for prurigo nodularis (PN) also planned. In addition, multiple Phase II trials are assessing its potential in PN, asthma, and chronic spontaneous urticaria. The drug is covered by compound and use patents in certain regions of its development territory. Currently, povorcitinib is in Phase II development for chronic urticaria.

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Briquilimab: Jasper Therapeutics

Briquilimab (JSP191) is a novel, unconjugated antibody designed to block the c-Kit receptor from binding with its natural ligand, stem cell factor (SCF). Since the SCF-c-Kit pathway is critical for mast cell survival, inhibiting this interaction triggers programmed mast cell death by disrupting a key survival mechanism.

Chronic Urticaria or Hives Pipeline Therapeutic Assessment

Chronic Urticaria or Hives Assessment by Product Type

- Mono

- Combination

- Mono/Combination

Chronic Urticaria or Hives By Stage

- 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 Urticaria or Hives Assessment by Route of Administration

- Intravenous

- Subcutaneous

- Oral

- Intramuscular

Chronic Urticaria or Hives Assessment by Molecule Type

- Monoclonal antibody

- Small molecule

- Peptide

Download the Chronic Urticaria or Hives Sample Report for Key Insights on the Chronic Urticaria or Hives Treatment Market and Therapeutics: https://www.delveinsight.com/report-store/chronic-urticaria-or-hives-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

Table of Contents

1. Report Introduction

2. Executive Summary

3. Chronic Urticaria or Hives Current Treatment Patterns

4. Chronic Urticaria or Hives - DelveInsight's Analytical Perspective

5. Therapeutic Assessment

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

7. Chronic Urticaria or Hives 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 Urticaria or Hives Discontinued Products

13. Chronic Urticaria or Hives Product Profiles

14. Chronic Urticaria or Hives Key Companies

15. Chronic Urticaria or Hives Key Products

16. Dormant and Discontinued Products

17. Chronic Urticaria or Hives Unmet Needs

18. Chronic Urticaria or Hives Future Perspectives

19. Chronic Urticaria or Hives Analyst Review

20. Appendix

21. Report Methodology

Request the Sample PDF to Get Detailed Insights About the Chronic Urticaria or Hives Pipeline Reports Offerings: https://www.delveinsight.com/sample-request/chronic-urticaria-or-hives-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr

About DelveInsight

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

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