DelveInsight’s “Celiac Disease – Pipeline Insight, 2026” report provides comprehensive insights about 25+ companies developing 30+ pipeline drugs in the Celiac Disease pipeline landscape. It covers the Celiac Disease pipeline drug profiles, including clinical and nonclinical stage products, along with therapeutics assessment by product type, stage, route of administration, and molecule type, and further highlights inactive pipeline products in this space.
Explore the latest breakthroughs in the Celiac Disease treatment landscape. Learn more about the evolving Celiac Disease pipeline today @ https://www.delveinsight.com/report-store/celiac-disease-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr
Key Takeaways from the Celiac Disease Pipeline Report
-
In June 2025, Forte Biosciences reported positive Phase 1b trial results for FB102 in celiac disease.
-
In May 2025, Teva Pharmaceutical Industries received FDA Fast Track designation for TEV-53408, an anti-IL-15 antibody in Phase 2a for celiac patients on gluten-free diets.
-
In May 2025, Targeted Genomics announced a commercial collaboration with OraSure Technologies for direct-to-consumer celiac genetic testing using GlutenID and ORAcollect Dx.
-
Celiac Disease companies: Teva Pharmaceutical Industries Ltd., Sanofi, Forte Biosciences, Inc., Takeda, Anokion, Entero Therapeutics, Amgen, Topas Therapeutics, Mozart Therapeutics Australia Pty Ltd, Barinthus Biotherapeutics, Hoffmann Roche, Immunic Therapeutic, Ahead Therapeutics, Equillium, Parvus Therapeutic and others.
-
Celiac Disease Emerging Therapies: Latiglutenase, TAK-101, TAK-227, Zamaglutenase (TAK-062), PRV-015 (Ordesekimab), KAN-101, TEV-53408, Amlitelimab, TPM-502, MTX-101, FB102, IMU-856, ZED1227.
Download for updates and the Celiac Disease advancements @ Celiac Disease Clinical Trials Assessment
Celiac Disease Emerging Drugs Profile
-
TEV‑53408: Teva Pharmaceutical Industries Ltd.
TEV‑53408 is an experimental monoclonal antibody designed for subcutaneous administration that selectively targets interleukin‑15 (IL‑15), a key cytokine driving gluten‑induced immune activation and intestinal inflammation in Celiac Disease. By blocking IL‑15 signaling, TEV‑53408 aims to attenuate the pathogenic immune cascade that leads to villous atrophy and symptom flares even with trace gluten exposure. The therapy has received FDA Fast Track designation and is currently in Phase II clinical development for Celiac Disease, positioning it among the most advanced pipeline candidates and reflecting strong regulatory interest in disease‑modifying biologics beyond dietary management.
-
VTP‑1000: Barinthus Biotherapeutics
VTP‑1000 is an investigational immunotherapy built on Barinthus Biotherapeutics’ SNAP‑Tolerance Immunotherapy (SNAP‑TI) platform, which co‑delivers gluten‑derived peptide antigens and the immunomodulator rapamycin via self‑assembled nanoparticles. Administered intramuscularly, these nanoparticles are engineered to target antigen‑presenting cells and promote a switch from pathogenic effector T‑cell responses to regulatory T‑cell–driven immune tolerance against gluten. VTP‑1000 is currently in Phase I clinical development for Celiac Disease and is highlighted by DelveInsight as a next‑generation approach that could re‑educate the immune system and provide sustained protection against gluten‑triggered intestinal damage.
For more information on the Celiac Disease Emerging Drugs Profile, download DelveInsight’s comprehensive Celiac Disease Pipeline Insight report.
The Celiac Disease Pipeline Report Provides
-
Detailed insights about companies developing therapies for Celiac Disease, with aggregate therapies developed by each company and their relative positioning across clinical stages.
-
Different therapeutic candidates, segmented into early‑stage, mid‑stage, and late‑stage development for Celiac Disease treatment, including Phase III, Phase II, Phase I, preclinical, and discovery assets.
-
Celiac Disease companies that are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects, enabling assessment of portfolio depth and strategic focus.
-
Celiac Disease drugs under development based on the stage of development, route of administration, target, monotherapy or combination therapy status, mechanism of action, and molecular type.
-
Detailed analysis of collaborations (company–company and company–academia), licensing agreements, and financing details that are shaping future advancement and competitive dynamics in the Celiac Disease market.
Learn more about Celiac Disease drugs opportunities in our groundbreaking research and development report @ Celiac Disease Unmet Needs
Celiac Disease Companies
There are 25+ key companies developing therapies for Celiac Disease, including Teva Pharmaceutical Industries, Barinthus Biotherapeutics, Topas Therapeutics, and several other biotechnology and pharmaceutical innovators advancing differentiated approaches such as cytokine blockade, antigen‑specific tolerance induction, and advanced biologics.
DelveInsight’s celiac disease pipeline report underscores that Teva’s TEV‑53408 currently represents one of the more advanced Phase II programs, while newer entrants like Barinthus Biotherapeutics and Topas Therapeutics are bringing first‑in‑class immunotherapies and tolerance‑inducing platforms into early‑ and mid‑stage clinical testing.
DelveInsight’s 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:
-
Intra‑articular
-
Intraocular
-
Intrathecal
-
Intravenous
-
Ophthalmic
-
Oral
-
Parenteral
Celiac Disease products have been categorized under various Molecule types such as:
-
Recombinant fusion protein
-
Small molecule
-
Monoclonal antibody
-
Peptide
-
Polymer
-
Gene therapy
Discover the latest advancements in Celiac Disease treatment. Stay informed @ Celiac Disease Market Drivers and Barriers, and Future Perspectives.
Scope of the Celiac Disease Pipeline Report
-
Coverage: Global, encompassing North America, Europe, Asia‑Pacific, and other key emerging markets.
-
Celiac Disease companies: Teva Pharmaceutical Industries, Barinthus Biotherapeutics, Topas Therapeutics, and other established and emerging players that collectively drive innovation across biologics, immune‑tolerance platforms, and novel modalities.
-
Celiac Disease Therapies: TEV‑53408, VTP‑1000, TPM502, FB102‑101, and other emerging agents that target gluten‑induced immune activation, restore tolerance, or protect against inadvertent gluten exposure.
-
Celiac Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination, allowing stakeholders to differentiate stand‑alone agents from regimens being developed to complement gluten‑free diets.
-
Celiac Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre‑clinical, Phase I, Phase II, Phase III, and inactive or discontinued candidates, to map maturation of the pipeline and identify late‑stage partnering or acquisition opportunities.
Table of Contents
-
Introduction
-
Executive Summary
-
Celiac Disease: Overview
-
Pipeline Therapeutics
-
Therapeutic Assessment
-
Celiac Disease – DelveInsight’s Analytical Perspective
-
Late Stage Products (Phase III)
-
Mid Stage Products (Phase II)
-
Early Stage Products (Phase I)
-
Preclinical and Discovery Stage Products
-
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
-
Appendix
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email:Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services
