Celiac Disease Pipeline

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 therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Geography Covered

• Global coverage

 

Celiac Disease: Understanding

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.

Common gastrointestinal symptoms include diarrhea, abdominal discomfort, bloating, and constipation, but the condition can also present with extraintestinal signs such as fatigue, weight loss, anemia, skin rashes, and osteoporosis. In children, growth failure is a frequent manifestation.

It arises from a combination of genetic, environmental, and immune factors. Genetic susceptibility is primarily linked to HLA class II genes, especially HLA-DQ2 and HLA-DQ8, present in almost all affected individuals, though not all carriers develop the disease. The key environmental trigger is dietary gluten, found in wheat, barley, and rye, which is broken down into peptides such as gliadin. In susceptible individuals, tissue transglutaminase-2 (tTG2) deamidates these peptides, enhancing their binding to HLA-DQ2/DQ8 molecules, activating T cells, and initiating an inflammatory response that damages the small intestinal lining.

It is an autoimmune disorder in genetically predisposed individuals (HLA-DQ2/DQ8) triggered by dietary gluten, particularly gliadin. Undigested gliadin peptides cross the intestinal barrier and are deamidated by tissue transglutaminase (tTG), forming complexes with HLA molecules on antigen-presenting cells. This activates CD4+ T cells, leading to cytokine-mediated inflammation, villous atrophy, crypt hyperplasia, and B- and CD8+ T cell–mediated tissue damage. Gliadin also increases intestinal permeability, amplifying immune activation. While many carriers of HLA-DQ2/DQ8 tolerate gluten, additional factors, such as infections, microbiome changes, or environmental triggers, may initiate disease. The result is characteristic intestinal injury and systemic manifestations including malabsorption, anemia, and extraintestinal symptoms.

The primary treatment for celiac disease is lifelong adherence to a strict gluten-free diet (GFD), which alleviates symptoms, promotes intestinal healing, and prevents long-term complications. Most patients experience symptom improvement within days to weeks, and regular follow-up is essential to monitor intestinal recovery, nutritional status, and growth in children. Gluten-free grains such as rice, corn, quinoa, millet, and sorghum replace wheat, barley, and rye, while careful attention is required to avoid cross-contamination in foods, medications, and supplements. Oats, if uncontaminated, are generally safe and enhance dietary variety. Managing a GFD can be challenging due to cost, meal preparation, dining out, and psychosocial impacts, making dietary education and support from registered dietitians crucial. Nutritional monitoring should address potential deficiencies in iron, calcium, folate, zinc, and vitamins D and B12, and supplementation may be necessary. Lifelong follow-up includes serologic testing to assess adherence and mucosal healing, with further evaluation for persistent symptoms or refractory disease. Comprehensive care encompassing dietary guidance, monitoring for complications, and psychosocial support is vital to ensure optimal health, quality of life, and prevention of long-term consequences.

 

"Celiac Disease- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Celiac Disease pipeline landscape is provided which includes the disease overview and Celiac Disease treatment guidelines. The assessment part of the report embraces, in depth Celiac Disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Celiac Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Celiac Disease R&D. The therapies under development are focused on novel approaches to treat/improve Celiac Disease.

 

Celiac Disease Emerging Drugs Chapters

This segment of the Celiac Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Celiac Disease Emerging Drugs

• TEV-53408: Teva Pharmaceutical Industries Ltd.

TEV-53408 is an experimental monoclonal antibody with subcutaneous route of administration targeting interleukin-15 (IL-15) to reduce the immune-mediated intestinal inflammation triggered by gluten in individuals with celiac disease. The FDA’s Fast Track designation for TEV-53408 highlights both the therapy’s potential and the significant unmet medical need for patients with this condition. Currently, the drug is in Phase II stage of its clinical study for the treatment of Celiac Disease.

 

• MTX-101: Mozart Therapeutics

MTX-101 is a bispecific autoimmune checkpoint inhibitor designed to restore immune balance. Its dual-target configuration binds CD8 Treg receptors KIR and CD8 to selectively activate CD8 regulatory T cells while enhancing the therapy’s specificity. MTX-101 functions by reinstating CD8 Treg activity and promoting the cytolytic elimination of pathogenic CD4 T cells. It is being developed for the treatment of early-stage and slowly progressing autoimmune diseases, including type 1 diabetes mellitus and celiac disease. Currently, the drug is in Phase I/II stage of its clinical study for the treatment of Celiac Disease.

 

• VTP-1000: Barinthus Biotherapeutics

VTP-1000 is an investigational immunotherapy from Barinthus Biotherapeutics designed to restore immune tolerance in celiac disease. Using the SNAP-Tolerance Immunotherapy (SNAP-TI) platform, it co-delivers gluten-derived peptide antigens with the immunomodulator rapamycin via self-assembled nanoparticles administered intramuscularly. These nanoparticles target antigen-presenting cells, promoting a shift from pathogenic T effector cells to regulatory T cells, thereby reducing inflammation and tissue damage from gluten exposure. Currently, the drug is in Phase I stage of its clinical study for the treatment of Celiac Disease.

Further product details are provided in the report……..

 

Celiac Disease: Therapeutic Assessment

This segment of the report provides insights about the different Celiac Disease drugs segregated based on following parameters that define the scope of the report, such as:

 

Major  Players in Celiac Disease

• There are approx. 25+ key companies which are developing the therapies for Celiac Disease. The companies which have their Celiac Disease drug candidates in the most advanced stage, i.e. Phase II include, Teva Pharmaceutical Industries Ltd.

 

Phases

DelveInsight’s report covers around 30+ products under different phases of clinical development like

• 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

 

Route of Administration

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

 

Molecule Type

Products have been categorized under various Molecule types such as

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

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Celiac Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Celiac Disease therapeutic drugs key players involved in developing key drugs.

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Celiac Disease drugs.

 

Celiac Disease Report Insights

• Celiac Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Celiac Disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Celiac Disease drugs?
• How many Celiac Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Celiac Disease?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Celiac Disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Celiac Disease and their status?
• What are the key designations that have been granted to the emerging drugs?