Celiac Disease Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | AMYRA Biotech AG, Equillium Bio., Chugai Pharmaceutical, Calypso Biotech

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Celiac Disease pipeline constitutes 25+ key companies continuously working towards developing 30+ Celiac Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Celiac Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Celiac Disease Market.

The Celiac Disease 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.

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Some of the key takeaways from the Celiac Disease Pipeline Report:

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

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Celiac Disease companies working in the treatment market are Takeda, AnokionSA, Mozart Therapeutics, AMYRA Biotech AG, Equillium Bio., Chugai Pharmaceutical Co., Ltd., Calypso Biotech, ImmunogenX, Inc., Amgen Inc., and others, are developing therapies for the Celiac Disease treatment

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Emerging Celiac Disease therapies in the different phases of clinical trials are- TAK-062, KAN-101, MTX 101, AMY02, EQ102, DONQ52, CALY-002, Latiglutenase, Ordesekimab, and others are expected to have a significant impact on the Celiac Disease market in the coming years.

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In June 2025, Forte Biosciences, Inc. (NASDAQ: FBRX), a clinical-stage biopharmaceutical company specializing in autoimmune and related disorders, has reported positive results from a Phase 1b trial of its lead candidate, FB102 (study FB102-101), in celiac disease.

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In May 2025, Teva Pharmaceutical Industries, Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug TEV-53408, an anti-IL-15 antibody, for the treatment of celiac disease in patients adhering to a gluten-free diet. TEV-53408 is currently undergoing evaluation in a Phase 2a clinical trial to determine its safety and effectiveness in adults with celiac disease. The FDA's Fast Track program aims to speed up the development and review of therapies for serious conditions with significant unmet medical needs.

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In March 2025, Barinthus Biotherapeutics plc (NASDAQ: BRNS) has entered 2025 with a renewed strategic focus on immunological and inflammatory diseases. Following its restructuring, the company is well-positioned to advance its lead asset, VTP-1000, along with the SNAP-TI platform, for the treatment of celiac disease. With innovative design features that enhance antigen targeting, allow intramuscular administration, and potentially improve tolerability, VTP-1000 has the potential to become a leading therapy for the approximately 80 million people worldwide affected by celiac disease.

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In February 2025, PhaseV, a leader in software and machine learning (ML) for clinical trial optimization, announced a strategic partnership with Alimentiv Inc., a global gastrointestinal (GI) contract research organization (CRO). This collaboration aims to enhance the design and execution of advanced adaptive clinical trials for various GI conditions, including inflammatory bowel disease (IBD), celiac disease, eosinophilic gastrointestinal disease (EGID), and other related disorders.

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In October 2024, Topas Therapeutics reported promising topline results from its Phase IIa trial of TPM502 in celiac disease patients. The findings provide the first clinical proof of concept for the company's proprietary nanoparticle platform, highlighting its potential to induce targeted, antigen-specific tolerogenic effects.

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In September 2024, Barinthus Biotherapeutics plc, a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies that direct T cells to combat disease, has commenced its first-in-human Phase I trial of VTP-1000 in adults with celiac disease.

Celiac Disease Overview

The World Gastroenterology Organization (WGO) defines celiac disease, also referred to as gluten-sensitive enteropathy, non-tropical sprue, or coeliac disease/sprue, as a chronic, multiple-organ small intestinal immune-mediated enteropathy that is precipitated in genetically predisposed individuals by exposure to dietary gluten.

Explore the latest Celiac Disease pipeline insights for 2025 and stay ahead in market trends and Celiac Disease emerging therapies [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Emerging Celiac Disease Drugs Under Different Phases of Clinical Development Include:

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TAK-062: Takeda

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KAN-101: AnokionSA

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MTX 101: Mozart Therapeutics

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AMY02: AMYRA Biotech AG

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EQ102: Equillium Bio.

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DONQ52: Chugai Pharmaceutical Co., Ltd.

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CALY-002: Calypso Biotech

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Latiglutenase : ImmunogenX, Inc.

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Ordesekimab: Amgen Inc.

Celiac Disease Route of Administration

Celiac Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

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Intra-articular

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Intraocular

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Intrathecal

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Intravenous

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Ophthalmic

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Oral

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Parenteral

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Subcutaneous

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Topical

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Transdermal

Celiac Disease Molecule Type

Celiac Disease Products have been categorized under various Molecule types, such as

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Oligonucleotide

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Peptide

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Small molecule

Celiac Disease Pipeline Therapeutics Assessment

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Celiac Disease Assessment by Product Type

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Celiac Disease By Stage and Product Type

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Celiac Disease Assessment by Route of Administration

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Celiac Disease By Stage and Route of Administration

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Celiac Disease Assessment by Molecule Type

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Celiac Disease by Stage and Molecule Type

DelveInsight's Celiac Disease Report covers around 30+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Celiac Disease product details are provided in the report. Download the Celiac Disease pipeline report to learn more about the emerging Celiac Disease therapies [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Celiac Disease Therapeutics Market include:

Key companies developing therapies for Celiac Disease are - Takeda Pharmaceutical Co Ltd, Amyra Biotech AG, Topas Therapeutics GmbH, Zedira GmbH, 9 Meters Biopharma Inc, Ahead Therapeutics SL, Allero Therapeutics BV, Amgen Inc, Anokion SA, AnTolRx Inc, Calypso Biotech SA., and others.

Celiac Disease Pipeline Analysis:

The Celiac Disease pipeline report provides insights into

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

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

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

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Celiac Disease 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.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Celiac Disease 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 Celiac Disease drugs and therapies [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Celiac Disease Pipeline Market Drivers

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Increasing prevalence of Celiac Disease, increasing R&D activities, No Approved Therapy are some of the important factors that are fueling the Celiac Disease Market.

Celiac Disease Pipeline Market Barriers

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However, limited patient awareness about the disease, poor Patient Compliance and other factors are creating obstacles in the Celiac Disease Market growth.

Scope of Celiac Disease Pipeline Drug Insight

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Coverage: Global

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Key Celiac Disease Companies: Takeda, AnokionSA, Mozart Therapeutics, AMYRA Biotech AG, Equillium Bio., Chugai Pharmaceutical Co., Ltd., Calypso Biotech, ImmunogenX, Inc., Amgen Inc., and others

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Key Celiac Disease Therapies: TAK-062, KAN-101, MTX 101, AMY02, EQ102, DONQ52, CALY-002, Latiglutenase, Ordesekimab, and others

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Celiac Disease Therapeutic Assessment: Celiac Disease current marketed and Celiac Disease emerging therapies

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Celiac Disease Market Dynamics: Celiac Disease market drivers and Celiac Disease market barriers

Request for Sample PDF Report for Celiac Disease Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Celiac Disease Report Introduction

2. Celiac Disease Executive Summary

3. Celiac Disease Overview

4. Celiac Disease- Analytical Perspective In-depth Commercial Assessment

5. Celiac Disease Pipeline Therapeutics

6. Celiac Disease Late Stage Products (Phase II/III)

7. Celiac Disease Mid Stage Products (Phase II)

8. Celiac Disease Early Stage Products (Phase I)

9. Celiac Disease Preclinical Stage Products

10. Celiac Disease Therapeutics Assessment

11. Celiac Disease Inactive Products

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

13. Celiac Disease Key Companies

14. Celiac Disease Key Products

15. Celiac Disease Unmet Needs

16 . Celiac Disease Market Drivers and Barriers

17. Celiac Disease Future Perspectives and Conclusion

18. Celiac Disease 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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