DelveInsight’s “Celiac Disease Pipeline Insight 2025” highlights major progress in tackling one of the fastest-growing autoimmune disorders worldwide. With Celiac Disease linked to multiple comorbidities—including diabetes, cardiovascular diseases, and certain cancers—the need for safer and more effective therapies has never been greater.
According to DelveInsight, the Celiac Disease pipeline features over 25 pharmaceutical and biotech companies developing 30+ novel therapeutic candidates, spanning early to late clinical stages. This surge in research activity reflects a strong global commitment to transforming patient outcomes through innovative science and precision medicine.
Leading companies driving advancements include Sanofi, Entero Therapeutics, Takeda, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Lumen Bioscience, and IGY Life Sciences, among others.
The report offers a comprehensive analysis of R&D progress, including clinical trials, mechanisms of action, and emerging treatment strategies—serving as an essential guide for researchers, investors, and healthcare decision-makers navigating the evolving Celiac Disease therapeutics landscape.
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Key Takeaways from the Celiac Disease Pipeline Report
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DelveInsight’s Celiac Disease Pipeline Report highlights a dynamic and expanding landscape, with 25+ active companies developing 30+ innovative therapies aimed at transforming Celiac Disease management.
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In May 2025, Teva’s TEV-53408, an anti–IL-15 monoclonal antibody, received FDA Fast Track Designation for treating adults with Celiac Disease triggered by gluten exposure—marking an important milestone toward faster development and regulatory review.
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Earlier, in February 2025, the FDA granted 510(k) clearance for GlutenID, the first over-the-counter genetic health-risk test designed to identify HLA gene variants (DQ2, DQ8, DQ2.2, DQ7) linked to Celiac Disease. While not diagnostic, this test enables convenient at-home risk assessment, with confirmation still requiring standard serology and biopsy.
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Key players advancing the field include Sanofi, Entero Therapeutics, Takeda, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Lumen Bioscience, and IGY Life Sciences, among others.
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Prominent pipeline candidates currently in development include TAK-062, KAN-101, MTX-101, and several others poised to reshape the future treatment landscape for Celiac Disease.
Celiac Disease Overview:
Celiac disease, also known as gluten-sensitive enteropathy, is an autoimmune disorder that primarily affects the small intestine. It develops when the immune system reacts abnormally to gluten, a protein present in wheat, barley, and rye, resulting in inflammation and damage to the intestinal lining. Although Samuel Gee first described the condition in 1888, the link between gluten and celiac disease was not discovered until 1953. Because it can affect multiple organ systems and cause a wide range of symptoms, celiac disease is often classified as a syndrome.
The disease presents with highly variable symptoms. Common gastrointestinal manifestations include chronic diarrhea, abdominal pain, bloating, nausea, constipation, and pale, foul-smelling stools. Beyond the digestive system, patients may experience fatigue, iron-deficiency anemia, joint pain, and neurological symptoms such as headaches, tingling, or numbness. In children, growth delays, irritability, and behavioral changes are frequently observed.
The pathogenesis of celiac disease involves a combination of genetic susceptibility, environmental triggers, and dietary exposure. Individuals carrying HLA-DQ2 or HLA-DQ8 genes are particularly prone to developing the condition. When gluten is consumed, it is incompletely digested, allowing fragments known as gliadin peptides to reach the intestinal lining—especially during infections that disrupt gut permeability. These peptides are modified by the enzyme tissue transglutaminase (tTg), which enhances their immunogenicity. This process activates innate and adaptive immune responses, resulting in the release of inflammatory cytokines and destruction of the intestinal villi, the finger-like projections responsible for nutrient absorption. The immune system also generates antibodies against gliadin and tTg, which further fuel inflammation and contribute to disease progression.
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Celiac Disease Pipeline Analysis
The Celiac Disease pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Celiac Disease Market.
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Categorizes Celiac Disease 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 Celiac Disease drugs under development based on:
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Stage of development
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Celiac Disease Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Celiac Disease 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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Celiac Disease Licensing agreements
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Funding and investment activities supporting future Celiac Disease market advancement.
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Unlock key insights into emerging Celiac Disease therapies and market strategies here: https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Celiac Disease Emerging Drugs
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TAK-062: Takeda
TAK-062 is a next-generation, highly potent enzyme—often referred to as a “super glutenase”—that has been computationally engineered to degrade gluten and represents a promising therapeutic candidate for celiac disease. In this autoimmune disorder, ingestion of gluten triggers inflammation and intestinal damage. TAK-062 is specifically optimized to target and break down the immunogenic gluten peptides, achieving over 99% gluten degradation—even after large or complex meals—in both in vitro studies and within the human stomach.
A Phase I clinical study evaluated the safety, tolerability, and gluten-degrading capability of TAK-062 in healthy participants and individuals with celiac disease. The enzyme is designed to neutralize gluten’s toxic components before they exit the stomach, potentially preventing immune activation and thereby reducing the symptoms and intestinal injury associated with the condition. Following promising early data, Takeda has initiated a Phase IIb clinical trial to further assess the efficacy and optimal dosing of TAK-062 in celiac patients who continue to experience symptoms despite strict adherence to a gluten-free diet.
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KAN-101: AnokionSA
KAN-101 is an investigational therapy developed by Kanyos Bio, Inc., a subsidiary of Anokion SA, for the treatment of celiac disease, a chronic autoimmune condition triggered by gluten ingestion. The therapy is designed to induce immune tolerance to gliadin, a major gluten component, through a liver-targeted delivery platform that engages receptors responsible for natural immune regulation. By leveraging these liver-specific pathways, KAN-101 aims to modulate the body’s immune response and prevent the inflammatory cascade typically caused by gluten exposure. The candidate is currently being evaluated in Phase II clinical trials to determine its safety, efficacy, and potential to restore gluten tolerance in individuals with celiac disease.
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MTX 101: Mozart Therapeutics
MTX-101 is a bispecific autoimmune checkpoint inhibitor designed to regulate immune activity in early-stage or slowly progressing autoimmune diseases, including celiac disease and type 1 diabetes. It employs a dual-binding approach that targets CD8 Treg receptors, KIR and CD8, to selectively activate regulatory CD8 T cells and improve therapeutic precision. MTX-101 restores the function of these regulatory T cells, allowing them to specifically eliminate pathogenic CD4 T cells that drive autoimmune responses. By acting early in disease progression, the therapy aims to suppress autoimmune activity, reduce inflammation, and protect tissues from damage. MTX-101 is currently being evaluated in Phase I clinical trials for celiac disease.
Celiac Disease Pipeline Therapeutic Assessment
Celiac Disease Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Celiac Disease 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
Celiac Disease Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Celiac Disease Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
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Table of Contents
1. Report Introduction
2. Executive Summary
3. Celiac Disease Current Treatment Patterns
4. Celiac Disease - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Celiac Disease Late-Stage Products (Phase-III)
7. Celiac Disease 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. Celiac Disease Discontinued Products
13. Celiac Disease Product Profiles
14. Celiac Disease Key Companies
15. Celiac Disease Key Products
16. Dormant and Discontinued Products
17. Celiac Disease Unmet Needs
18. Celiac Disease Future Perspectives
19. Celiac Disease Analyst Review
20. Appendix
21. Report Methodology
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