Urticaria Pipeline 2024: Clinical Trials Assessment, FDA Approvals, Therapies, and Key Companies Involved by DelveInsight | Sanofi, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPhar

(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Urticaria pipeline constitutes 20+ key companies continuously working towards developing 25+ Urticaria treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

Urticaria Pipeline Insight, 2024 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Urticaria Market.


The Urticaria Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.


Some of the key takeaways from the Urticaria Pipeline Report:

Companies across the globe are diligently working toward developing novel Urticaria treatment therapies with a considerable amount of success over the years. 

Urticaria companies working in the treatment market are Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, Regeneron, GlaxoSmithKline, Taiho Pharma, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, and others, are developing therapies for the Urticaria treatment 

Emerging Urticaria therapies in the different phases of clinical trials are- Ligelizumab, Remibrutinib (LOU064), Tezepelumab, CDX-0159, GI-301, Dupilumab (DUPIXENT), UB-221, MTPS9579A, Lirentelimab (AK002), TAS5315, rilzabrutinib, GDC-0853, AZD1981, Desloratadine, and others are expected to have a significant impact on the Urticaria market in the coming years.   

In March 2024, Celltrion has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for CT-P39, a biosimilar candidate to XOLAIR (omalizumab), aimed at treating chronic spontaneous urticaria (CSU). This submission marks a crucial step towards introducing an interchangeable biosimilar for CSU treatment. The BLA is supported by evidence, including data from a global Phase III clinical trial comparing CT-P39 to the reference therapy XOLAIR.

In January 2024, Evommune has initiated a Phase I first-in-human clinical trial for EVO756, a new oral treatment for chronic spontaneous urticaria (CSU). This trial aims to evaluate the tolerability, safety, and pharmacokinetics of EVO756 in both healthy adults and adult CSU patients. The randomized, placebo-controlled, double-blind study will examine single and multiple ascending doses (SAD and MAD) in healthy participants, while also including an open-label study for CSU patients.

In November 2023, Novartis’ remibrutinib successfully met all primary and secondary endpoints at 12 weeks in the Phase III REMIX-1 and REMIX-2 trials for adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines. Remibrutinib, a selective Bruton’s tyrosine kinase (BTK) inhibitor, works by inhibiting histamine release through the BTK pathway. This histamine release is responsible for CSU symptoms such as itching, hives, and swelling.


Urticaria Overview

Urticaria, commonly known as hives, is a skin condition characterized by the sudden appearance of red, itchy welts or wheals on the skin. These welts can vary in size and shape, often merging together to form larger areas of raised skin. Urticaria can be acute, lasting less than six weeks, or chronic, persisting for more than six weeks.


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Emerging Urticaria Drugs Under Different Phases of Clinical Development Include:

Ligelizumab: Novartis

Remibrutinib (LOU064): Novartis

Tezepelumab: Amgen

CDX-0159: Celldex Therapeutics

GI-301: GI Innovation

Dupilumab (DUPIXENT): Sanofi/ Regeneron

UB-221: United BioPharma

MTPS9579A: Genentech

Lirentelimab (AK002): Allakos Inc.

TAS5315: Taiho Pharma

rilzabrutinib: Sanofi

GDC-0853: Genentech, Inc.

AZD1981: AstraZeneca

Desloratadine: Organon and Co


Urticaria Route of Administration

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 







Urticaria Molecule Type

Urticaria Products have been categorized under various Molecule types, such as

Recombinant fusion proteins

Small molecule

Monoclonal antibody



Gene therapy


Urticaria Pipeline Therapeutics Assessment

Urticaria Assessment by Product Type

Urticaria By Stage and Product Type

Urticaria Assessment by Route of Administration

Urticaria By Stage and Route of Administration

Urticaria Assessment by Molecule Type

Urticaria by Stage and Molecule Type


DelveInsight’s Urticaria 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)

Pre-clinical and Discovery stage candidates

Discontinued & Inactive candidates

Route of Administration


Further Urticaria product details are provided in the report. Download the Urticaria pipeline report to learn more about the emerging Urticaria therapies


Some of the key companies in the Urticaria Therapeutics Market include:

Key companies developing therapies for Urticaria are – Sanofi, Genentech, AstraZeneca, Kiniksa Pharmaceuticals, Ltd, United BioPharma, Roche, Novartis, GlaxoSmithKline, Allakos, Eli Lilly and Company and others.


Urticaria Pipeline Analysis:

The Urticaria pipeline report provides insights into 

The report provides detailed insights about companies that are developing therapies for the treatment of Urticaria with aggregate therapies developed by each company for the same.

It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Urticaria Treatment.

Urticaria key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

Urticaria 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 Urticaria market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.


Download Sample PDF Report to know more about Urticaria drugs and therapies


Urticaria Pipeline Market Drivers

Treatment Side Effects with Currently Available Treatment, Economic Burden on Patients, Increase in Research and Development Activities, Increasing Market Size, are some of the important factors that are fueling the Urticaria Market.


Urticaria Pipeline Market Barriers

However, Lack of Understanding of Disease Pathology, Approaching Patent Cliff, and other factors are creating obstacles in the Urticaria Market growth.


Scope of Urticaria Pipeline Drug Insight    

Coverage: Global

Key Urticaria Companies: Allakos, AstraZeneca, Biosana, Celldex Therapeutics, Celltrion, Eli Lilly and Company, Genentech, GI Innovation/Yuhan, Regeneron, GlaxoSmithKline, Taiho Pharma, Glenmark Pharmaceuticals, Gossamer Bio, Kiniksa Pharmaceuticals, Mycenax Biotech, Novartis, Regeneron, Synermore Biologics, UCB Biopharma, United BioPharma, and others

Key Urticaria Therapies: Ligelizumab, Remibrutinib (LOU064), Tezepelumab, CDX-0159, GI-301, Dupilumab (DUPIXENT), UB-221, MTPS9579A, Lirentelimab (AK002), TAS5315, rilzabrutinib, GDC-0853, AZD1981, Desloratadine, and others

Urticaria Therapeutic Assessment: Urticaria current marketed and Urticaria emerging therapies

Urticaria Market Dynamics: Urticaria market drivers and Urticaria market barriers 


Request for Sample PDF Report for Urticaria Pipeline Assessment and clinical trials


Table of Contents

1. Urticaria Report Introduction

2. Urticaria Executive Summary

3. Urticaria Overview

4. Urticaria- Analytical Perspective In-depth Commercial Assessment

5. Urticaria Pipeline Therapeutics

6. Urticaria Late Stage Products (Phase II/III)

7. Urticaria Mid Stage Products (Phase II)

8. Urticaria Early Stage Products (Phase I)

9. Urticaria Preclinical Stage Products

10. Urticaria Therapeutics Assessment

11. Urticaria Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Urticaria Key Companies

14. Urticaria Key Products

15. Urticaria Unmet Needs

16 . Urticaria Market Drivers and Barriers

17. Urticaria Future Perspectives and Conclusion

18. Urticaria Analyst Views

19. Appendix

20. About DelveInsight



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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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Company Name: DelveInsight Business Research
Contact Person: Gaurav Bora
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Phone: +14699457679
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Country: United States
Website: https://www.delveinsight.com/consulting/asset-prioritizaton-services

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