Celiac Disease Pipeline: Pioneering Progress with 25+ Leading Companies Developing Groundbreaking Therapies | DelveInsight

The Celiac Disease market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Sanofi, Entero Therapeutics, Takeda, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, and Equillium. These industry pioneers are transforming treatment strategies and redefining the future of Celiac Disease, bringing new hope to patients worldwide.

DelveInsight's "Celiac Disease Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Celiac Disease market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Celiac Disease drugs, the Celiac Disease pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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 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.
• In January 2024, Calypso Biotech BV announced it had entered into an agreement to be acquired by Novartis AG. Calypso's shareholders received an upfront payment of $250 million upon closing, with potential development milestones of up to $175 million. This acquisition gives Novartis full rights to CALY-002, which it plans to explore across various autoimmune indications with significant unmet medical needs.
• In October 2023, the FDA granted 510(k) clearance to Werfen for its Aptiva Connective Tissue Disease Essential reagent, aiding in the diagnosis of autoimmune diseases. This expands Werfen's Aptiva lab system, which also includes the previously cleared Aptiva Celiac Disease IgG reagent, allowing labs to process multiple analytes from a single sample.

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Celiac Disease Overview
Celiac disease, or gluten-sensitive enteropathy, is an autoimmune disorder of the small intestine triggered by the ingestion of gluten. When gluten is consumed, the immune system mistakenly attacks the small intestine, causing inflammation and damage. The condition was first described in 1888 by Samuel Gee, with gluten's role becoming clear in 1953. Celiac disease presents with a wide range of symptoms, including chronic diarrhea, abdominal pain, bloating, constipation, nausea, fatigue, anemia (often iron deficiency), joint pain, and neurological issues like headaches or numbness. In children, it can also cause delayed growth and mood changes.

The disease's pathogenesis involves a combination of genetic predisposition (especially HLA DQ2 and DQ8), environmental factors, and gluten exposure. Gluten is poorly digested, leading to the presence of gliadin fragments that trigger an immune response, causing inflammation and villous atrophy in the small intestine. This immune reaction also produces antibodies against tissue transglutaminase (tTg) and gliadin, which contribute to inflammation.

Diagnosis typically includes serological tests for tTG-IgA and endomysial antibodies (EMA), followed by an intestinal biopsy to assess damage to the villi. It is essential for patients to continue consuming gluten before testing to avoid false negatives. The primary treatment is a lifelong gluten-free diet, along with possible vitamin and mineral supplements. In severe cases, corticosteroids may be prescribed. Regular follow-ups are needed to monitor nutritional status and treatment effectiveness.

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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.

Key Celiac Disease Therapies and Companies
• TAK-062: Takeda
• PTG-100: Protagonist Therapeutics
• EQ 102: Equillium

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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.

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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

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This release was published on openPR.