Press release
Celiac Disease Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Celiac Disease Treatment Landscape @ Celiac Disease Pipeline Outlook [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Key Takeaways from the Celiac Disease Pipeline Report
* On 15 August 2025, Sanofi announced a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).
* On 08 August 2025, Topas Therapeutics GmbH conducted a Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD. The patients participation in the study comprises 3 phases: screening period, treatment period and follow-up period.
* 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.
Discover groundbreaking developments in Celiac Disease Therapies! Gain in-depth knowledge of key clinical trials, emerging drugs, and market opportunities @ Celiac Disease Ongoing Clinical Trials Assessment [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
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
Stay informed about the Celiac Disease pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Celiac Disease Unmet Needs [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
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
Transform your understanding of the Celiac Disease Pipeline! See the latest progress in drug development and clinical research @ Celiac Disease Market Drivers and Barriers, and Future Perspectives [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
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
Stay Ahead in Immunological and Autoimmune Disorders Research-Access the Full Celiac Disease Pipeline Analysis Today! @ Celiac Disease Drugs and Companies [https://www.delveinsight.com/sample-request/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
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
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
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