Celiac Disease Clinical Trials 2025: Medication, Pipeline Analysis, EMA, PDMA, FDA Approvals, Treatment Market, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight

(Albany, USA) DelveInsight's "Celiac Disease Pipeline Insight 2025" report provides a detailed and strategic evaluation of the ongoing R&D landscape. It covers clinical trial progression, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. The report serves as a crucial resource for stakeholders, including researchers, healthcare investors, and decision-makers, seeking insights into the evolving Celiac Disease Therapeutics Market and the breakthroughs shaping its future trajectory.

According to DelveInsight, the Celiac Disease pipeline comprises 25+ pharmaceutical and biotech companies actively developing 30+ therapeutic candidates targeting Celiac Disease. These therapies span various stages of clinical and non-clinical development, underscoring the intense innovation and commitment to addressing one of the most pressing public health challenges of our time. With Celiac Disease reaching epidemic proportions globally and contributing significantly to comorbid conditions such as diabetes, cardiovascular disease, and certain cancers, there is a growing demand for safer, more effective treatment options.

Explore the Cutting-Edge Landscape of Celiac Disease Drug Development @ https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Key Takeaways from the Celiac Disease Pipeline Report
• DelveInsight's Celiac Disease pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for Celiac Disease treatment.
• In May, 2025, TEV-53408, an anti-IL‐15 monoclonal antibody under development by Teva, received FDA Fast Track designation as a treatment for adults with celiac disease following gluten exposure. This designation supports accelerated development and review.
• In February, 2025, the FDA issued 510(k) clearance for GlutenID, the first over-the-counter genetic health-risk test that detects HLA gene variants (DQ2, DQ8, DQ2.2, DQ7) associated with celiac disease. It enables at-home risk screening but is not a diagnostic tool-standard serology and biopsy remain necessary for diagnosis.
• Key Celiac Disease companies such as 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 new drugs for Celiac Disease to improve the treatment landscape.
• Promising Celiac Disease pipeline therapies in various stages of development include TAK-062, KAN-101, MTX 101, and others.

Celiac Disease Overview:
Celiac disease, also referred to as gluten-sensitive enteropathy, is an autoimmune disorder affecting the small intestine. It occurs when the body mounts an abnormal immune response to gluten-a protein found in wheat, barley, and rye-leading to inflammation and damage of the intestinal lining. Although first described by Samuel Gee in 1888, the connection between gluten and the condition was only established in 1953. Celiac disease is often considered a syndrome due to its broad spectrum of symptoms and its impact on multiple body systems.

The disease manifests differently among individuals. Common gastrointestinal symptoms include chronic diarrhea, abdominal discomfort, bloating, nausea, constipation, and pale, foul-smelling stools. However, many patients also experience extra-intestinal symptoms such as fatigue, iron-deficiency anemia, joint pain, and neurological issues like headaches, tingling, or numbness. In children, signs may also include poor growth, irritability, and mood disturbances.

The development of celiac disease involves a combination of genetic, environmental, and dietary factors. Individuals who carry the HLA-DQ2 or HLA-DQ8 genes are at higher risk. When gluten is consumed, it is not fully broken down in the upper digestive tract, allowing large fragments called gliadin peptides to reach the small intestinal lining-particularly during infections that compromise gut integrity. These peptides are altered by the enzyme tissue transglutaminase (tTg), increasing their ability to trigger an immune response. This activates both innate and adaptive immunity, causing the release of inflammatory cytokines and damage to the intestinal villi, a hallmark of the disease. Additionally, the immune system produces antibodies against gliadin and tTg, which, although not directly harmful, can exacerbate inflammation and contribute to disease progression.

Download the Celiac Disease sample report to know in detail about the Celiac Disease treatment market @ https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Celiac Disease Pipeline Analysis
The Celiac Disease pipeline insights report 2025, provides insights into:
• Provides comprehensive insights into key companies developing therapies in the Celiac Disease Market.
• Categorizes Celiac Disease therapeutic companies by development stage: early, mid, and late-stage.
• Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.

Reviews emerging Celiac Disease drugs under development based on:
• Stage of development
• Celiac Disease Route of administration
• Target receptor
• Monotherapy vs. combination therapy
• Celiac Disease Mechanism of action
• Molecular type

Offers detailed analysis of:
• Company-to-company and company-academia collaborations
• Celiac Disease Licensing agreements
• Funding and investment activities supporting future Celiac Disease market advancement.

Unlock key insights into emerging Celiac Disease therapies and market strategies here: https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Celiac Disease Emerging Drugs
TAK-062: Takeda
TAK-062 is a next-generation, highly potent enzyme-known as a super glutenase-engineered through computational design to break down gluten and offer a potential new treatment for celiac disease. In this autoimmune condition, gluten ingestion triggers inflammation and damage to the small intestine. TAK-062 is specifically designed to target and degrade the immunogenic fragments of gluten peptides, achieving over 99% breakdown of gluten-even in large, complex meals-both in vitro and in the human stomach.

In a Phase I clinical trial, the safety and tolerability of TAK-062 were assessed in both healthy individuals and people with celiac disease. The study also evaluated its ability to degrade gluten in healthy volunteers. The enzyme is intended to neutralize gluten's harmful components before they leave the stomach, helping to prevent the immune reaction and, in turn, reduce the symptoms and intestinal injury associated with the disease. Takeda has since launched a Phase IIb trial to further evaluate TAK-062's efficacy and determine optimal dosing in celiac patients who continue to experience symptoms despite adhering to a gluten-free diet.

KAN-101: AnokionSA
KAN-101 is an experimental treatment developed by Kanyos Bio, Inc., a subsidiary of Anokion SA, intended for managing celiac disease-a long-term autoimmune disorder triggered by gluten consumption. The therapy aims to promote immune tolerance to gliadin, a key component of gluten, using a liver-targeting platform that activates specific liver receptors involved in natural immune regulation. By engaging these pathways, KAN-101 seeks to reduce the immune system's harmful response to gluten. The drug is currently undergoing Phase II clinical trials to assess its effectiveness in treating celiac disease.

MTX 101: Mozart Therapeutics
MTX-101 is a bispecific autoimmune checkpoint inhibitor designed to modulate immune responses in early-stage and slow-progressing autoimmune conditions such as celiac disease and type 1 diabetes. The drug features a dual-binding mechanism that targets the CD8 Treg receptors, KIR and CD8, to specifically activate regulatory CD8 T cells and enhance its precision. MTX-101 works by restoring the function of these regulatory T cells and enabling them to selectively eliminate harmful CD4 T cells that drive autoimmune activity. By intervening early in the disease process, MTX-101 aims to suppress autoimmune responses, reduce inflammation, and prevent tissue damage. It is currently in Phase I clinical development for the treatment of 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

Download sample pages to get an in-depth assessment of the emerging Celiac Disease therapies and key Celiac Disease companies: https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.