Celiac Disease Clinical Trials Analysis 2025 Novel Immunotherapies and Gut-Targeted Therapies Aim to Redefine Care | DelveInsight

DelveInsight's "Celiac Disease - Clinical Trials Analysis, 2025" highlights a rapidly progressing pipeline addressing the limitations of the gluten-free diet, the only current standard of care. With patients continuing to face accidental gluten exposure and persistent symptoms, innovative therapies are advancing to fill this critical gap.

Clinical trials are exploring therapeutic vaccines, oral enzymes that degrade gluten, and tight junction modulators designed to reduce intestinal permeability. Emerging biologics targeting immune pathways, such as IL-15 and TG2, are also showing promise in modifying disease progression rather than just symptom control.

Late-stage candidates, including novel small molecules and immunotherapies, are moving toward pivotal studies, while regulatory designations are accelerating development. Together, these efforts are reshaping the celiac disease treatment landscape, with the potential to deliver safer, more effective, and convenient alternatives beyond dietary management.

Explore the full pipeline analysis for celiac disease and uncover key opportunities @ https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Celiac Disease Pipeline Report
• DelveInsight's Celiac Disease Pipeline analysis depicts a robust space with 25+ active players working to develop 30+ pipeline drugs for Celiac Disease treatment.
• The leading Celiac Disease companies include Sanofi, Entero Therapeutics, Takeda, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Lumen Bioscience, IGY Life Sciences, and others are evaluating their lead assets to improve the Celiac Disease treatment landscape.
• Key Celiac Disease pipeline therapies in various stages of development include PRV-015, Latiglutenase, TAK-227, Ritlecitinib, TPM-502, KAN 101, PTG-100, EQ 102, AMY02, FB 102, LPX-TIGI, AT 1718, Research program, IgY-112, and others.
• In October 2024, Topas Therapeutics announced positive topline results from its Phase IIa trial of TPM502 in patients with celiac disease. This study provided the first clinical proof of concept for Topas' proprietary nanoparticle platform, demonstrating its potential to induce targeted, antigen-specific tolerogenic effects.
• In May 2025, Teva Pharmaceutical announced FDA Fast Track designation for TEV-53408, an anti-IL-15 antibody in Phase 2a trials for treating adults with celiac disease on a gluten-free diet.
• In September 2024, Barinthus Biotherapeutics plc, a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that guide T cells to manage diseases, launched its first-in-human Phase I trial of VTP-1000 in adults with celiac disease.
• In May 2024, Entero Therapeutics, Inc. (formerly First Wave BioPharma, Inc.) unveiled its new name and website following its recent business combination with ImmunogenX. This rebranding reflects the company's commitment to addressing unmet needs in gastrointestinal (GI) health, including celiac disease, for which no approved medicines currently exist.
• In March 2024, First Wave BioPharma announced its acquisition of ImmunogenX in an all-stock transaction. The combined company aims to advance a GI pipeline featuring multiple late-stage clinical assets, including latiglutenase, a potentially first-in-class, near Phase III-ready oral biotherapeutic for celiac disease.
• In February 2024, following the approval of the SQZ transaction, STEMCELL acquired most of SQZ's assets, including its extensive portfolio of over 400 patents, trademarks, copyrights, trade secrets, proprietary equipment, and its head license with the Massachusetts Institute of Technology.

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Celiac Disease Overview
Celiac disease, or gluten-sensitive enteropathy, is an autoimmune disorder where the immune system attacks the small intestine after gluten ingestion, causing inflammation and damage. First identified in 1888, with gluten's role clarified in 1953, it presents with symptoms like chronic diarrhea, abdominal pain, bloating, fatigue, anemia, joint pain, and neurological issues. In children, it can cause delayed growth and mood changes. The disease involves genetic factors (especially HLA DQ2/DQ8), gluten exposure, and immune responses that damage the intestine. Diagnosis is confirmed through serological tests (tTG-IgA, EMA) and an intestinal biopsy. The primary treatment is a lifelong gluten-free diet, with possible vitamin supplements, and corticosteroids in severe cases. Regular follow-ups are essential to monitor progress.

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Celiac Disease Treatment Analysis: Drug Profile
TAK-062: Takeda
TAK-062 is a promising, highly potent super glutenase protein developed to treat celiac disease. This enzyme targets and breaks down ingested gluten, preventing it from triggering the immune response that leads to inflammation and damage in the small intestine. Engineered to have high specificity for immunogenic gluten peptides, TAK-062 can degrade over 99% of gluten, even in high amounts, as shown in human stomach studies and in vitro. A Phase I study assessed its safety and tolerability in both healthy individuals and those with celiac disease. TAK-062 is designed to reduce the immune-reactive components of gluten before they leave the stomach, preventing immune reactions and alleviating symptoms and intestinal damage caused by celiac disease. Takeda has initiated a Phase IIb efficacy and dose-ranging trial in patients with uncontrolled celiac disease who follow a gluten-free diet.

PTG-100: Protagonist Therapeutics
PTG-100 is an oral peptide that blocks the alpha-4-beta-7 integrin, a receptor involved in gastrointestinal inflammation. Developed in collaboration with Nielsen Fernandez-Becker of Stanford University, Protagonist Therapeutics has completed a Phase I study to investigate whether PTG-100 can reduce or prevent the inflammation in the small intestine caused by gluten consumption in people with celiac disease. Currently, PTG-100 is in Phase I clinical trials for the treatment of celiac disease.

Learn more about the novel and emerging Celiac Disease pipeline therapies @ https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Celiac Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Celiac Disease Pipeline Report
• Coverage: Global
• Key Celiac Disease Companies: Sanofi, Entero Therapeutics, Takeda, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Lumen Bioscience, IGY Life Sciences, and others.
• Key Celiac Disease Pipeline Therapies: PRV-015, Latiglutenase, TAK-227, Ritlecitinib, TPM-502, KAN 101, PTG-100, EQ 102, AMY02, FB 102, LPX-TIGI, AT 1718, Research program, IgY-112, and others.

Dive deep into rich insights for drugs used for Celiac Disease treatment; visit @ https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Celiac Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Celiac Disease Pipeline Therapeutics
6. Celiac Disease Pipeline: Late-Stage Products (Phase III)
7. Celiac Disease Pipeline: Late-Stage Products (Phase III)
8. Celiac Disease Pipeline: Mid-Stage Products (Phase II)
9. Celiac Disease Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.