Celiac Disease Pipeline Insights Report 2025: Emerging Therapies, Mechanisms of Action, and Clinical Advancements Shaping the Pharma Landscape

DelveInsight's, "Celiac Disease Pipeline Insight 2025" report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in Celiac Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Celiac Disease pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Celiac Disease Pipeline Report

* On 18 November 2025, Forte Biosciences Inc. announced a study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.
* On 17 November 2025, Massachusetts General Hospital conducted a study will impact the therapeutic options in the future for individuals with CeD. The investigators are proposing a double blind, placebo-controlled trial to establish safety and efficacy of Ritlecitinib to prevent gluten-induced celiac enteropathy and symptoms in celiac disease (CeD) patients in remission.
* On 07 November 2025, Teva Branded Pharmaceutical Products R&D LLC initiated a trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease. The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease. The expected trial duration per participant is approximately 86 weeks.
* DelveInsight's Celiac Disease pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for Celiac Disease treatment.
* The leading 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.
* Promising Celiac Disease Pipeline Therapies such as KAN-101, Amlitelimab, TPM502, Ritlecitinib, ALV003, TEV-53408 and others.

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The Celiac Disease Pipeline Report provides a disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Celiac Disease Pipeline Report also highlights the unmet needs with respect to Celiac Disease.

Celiac Disease Overview

Celiac disease is an autoimmune disorder in which the small intestine mounts an immune-mediated response to dietary gluten, a protein found in wheat, barley, and rye. While historically regarded as a gastrointestinal condition primarily causing malabsorption, it is now recognized as a systemic autoimmune disorder. The disease manifests in genetically susceptible individuals and persists lifelong, leading to immune-driven damage to the intestinal lining upon gluten exposure. This damage is characterized by villous atrophy, crypt hyperplasia, and infiltration of immune cells into the lamina propria, resulting in malabsorption of essential nutrients, including micronutrients, fat-soluble vitamins, iron, vitamin B12, and folate.

Celiac Disease Emerging Drugs Profile

* TAK-062: Takeda

TAK-062 is a potential best-in-class, highly potent super glutenase - a protein that degrades ingested gluten that was computationally engineered to treat celiac disease. In this serious autoimmune disease, the ingestion of gluten leads to inflammation and damage in the small intestine. TAK-062 has high specificity for immunogenic fractions of gluten peptides and can degrade >99% of even high amounts of gluten in a complex study meal in the human stomach and in vitro. The Phase I study investigated TAK-062's safety and tolerability in healthy volunteers and people with celiac disease. The ability of TAK-062 to degrade ingested gluten was studied in healthy volunteers. It is designed to lessen the immune-reactive parts of gluten before they exit the stomach to prevent the immune response to gluten and eliminate the symptoms and intestinal damage caused by celiac disease. Takeda has initiated a Phase IIb study efficacy and dose-ranging study of TAK-062 in patients with the uncontrolled disease who maintain a gluten-free diet.

* KAN-101: AnokionSA

KAN-101 is an investigational therapy developed by Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA, aimed at treating celiac disease, a chronic autoimmune condition triggered by gluten. This drug is designed to induce immune tolerance to gliadin, a component of gluten, by leveraging a liver-targeting platform that engages specific receptors in the liver to promote a natural immune tolerance pathway. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of Celiac disease.

* MTX 101: Mozart Therapeutics

MTX-101 is a bispecific autoimmune checkpoint inhibitor. It's dual configuration binds the CD8 Treg receptors, KIR and CD8, to selectively activate CD8 Treg and enhance MTX-101's specificity, respectively. MTX-101 is designed to restore CD8 Treg functionality and the cytolytic elimination of pathogenic CD4 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of regulatory CD8 T cells, acting early in the autoimmune disease process to suppress and eliminate pathogenic autoimmune cells, halt downstream inflammation, and prevent tissue destruction. MTX-101 is being developed for early stage and slowly-progressing autoimmune diseases, such as type 1 diabetes mellitus and celiac disease. Currently the drugs is in Phase I stage of development for the treatment of celiac disease.

The Celiac Disease Pipeline Report Provides Insights into

* 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.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Celiac Disease Treatment.
* Celiac Disease Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* 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.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Celiac Disease market

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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.

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

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

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

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the Celiac Disease Pipeline Report

* Coverage- Global
* 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.
* Celiac Disease Pipeline Therapies- KAN-101, Amlitelimab, TPM502, Ritlecitinib, ALV003, TEV-53408 and others.
* Celiac Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Celiac Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Celiac Disease: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Celiac Disease- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Drug name: Company name
* Mid Stage Products (Phase II)
* TAK-062: Takeda
* Early Stage Products (Phase I)
* MTX 101: Mozart Therapeutics
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Inactive Products
* Celiac Disease Key Companies
* Celiac Disease Key Products
* Celiac Disease- Unmet Needs
* Celiac Disease- Market Drivers and Barriers
* Celiac Disease- Future Perspectives and Conclusion
* Celiac Disease Analyst Views
* Celiac Disease Key Companies
* Appendix

About Us

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