Celiac Disease - Pipeline Insight, 2025

This “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.

Celiac Disease: Understanding

Celiac Disease: Overview

Celiac Disease, also known as gluten-sensitive enteropathy, is an autoimmune disease of the small intestine. Celiac disease is when the body responds to gluten with an inappropriate immune response causing small intestinal inflammation and damage. Celiac disease was first described in 1888 by Samuel Gee, but only in 1953 gluten become clear in the origin of this pathology. Celiac disease (CeD) might be considered a syndrome due to the wide spectrum of clinical manifestations and the involvement of various human systems. Celiac disease is an autoimmune disorder triggered by the ingestion of gluten, leading to a wide range of symptoms that can vary significantly among individuals. Common digestive symptoms include chronic diarrhea, abdominal pain, bloating, constipation, and nausea, often accompanied by pale, foul-smelling stools. Beyond gastrointestinal issues, many patients experience non-digestive symptoms such as fatigue, anemia (often due to iron deficiency), joint pain, and neurological problems like headaches or numbness. In children, symptoms may also include delayed growth and mood changes.

Celiac disease pathogenesis involves a complex interplay of genetic predisposition, environmental factors, and gluten exposure. Individuals with specific genetic markers, particularly HLA DQ2 or DQ8, are more susceptible to the disease. When gluten is ingested, it is poorly digested in the upper gastrointestinal tract, leading to the presence of large gliadin molecules that can penetrate the intestinal lining, especially during gastrointestinal infections. These gliadin fragments are modified by tissue transglutaminase (tTg), enhancing their immunogenicity. The immune system responds by activating both innate and adaptive immune pathways, resulting in the release of pro-inflammatory cytokines and subsequent tissue damage characterized by villous atrophy and inflammation in the small intestine. This immune response also generates antibodies against tTg and gliadin, which, while not directly damaging, may amplify the local inflammatory response.

Diagnosis of celiac disease typically involves a combination of serological tests and intestinal biopsy. Initially, healthcare providers conduct blood tests to measure specific antibodies, such as tissue transglutaminase antibodies (tTG-IgA) and endomysial antibodies (EMA), which are often elevated in individuals with the disease. If these tests indicate a potential diagnosis, an intestinal biopsy is performed to assess for damage to the villi in the small intestine, which is a hallmark of celiac disease. It is crucial for patients to continue consuming gluten prior to testing to ensure accurate results, as eliminating gluten can lead to false negatives. The primary treatment for celiac disease is a strict, lifelong gluten-free diet, avoiding all foods containing wheat, barley, and rye. Patients must read labels carefully and may need vitamin and mineral supplements to address deficiencies. In severe cases, medications like corticosteroids may be prescribed, and regular follow-ups are crucial to monitor response and nutritional status.

'Celiac Disease- Pipeline Insight, 2025' report 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

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.

PTG-100: Protagonist Therapeutics

PTG-100 is an oral peptide that blocks the function of alpha-4-beta-7 integrin, a cell receptor involved in the gastrointestinal inflammatory response. Nielsen Fernandez-Becker, head of the Celiac Disease Program at Stanford University in collaboration with Protagonist Therapeutics, completed a Phase I study to learn whether PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. Currently, the drug is in the Phase I stage of its development for the treatment of Celiac Disease.

EQ 102: Equillium

EQ102 is a first-in-class, selective inhibitor of IL-15 and IL-21. It has undergone substantial translational work supporting its potential use as a treatment for various gastrointestinal diseases. Phase I is ready for a study to include a proof-of-concept evaluation in patients with celiac disease, an immune disorder related to gluten exposure. EQ102 has been shown to inhibit both IL-15 and IL-21-induced signaling pathways in celiac patient-derived intraepithelial cytotoxic T-lymphocytes and key genes for tissue destruction in patient-derived organoid cultures. Similarly, in preclinical studies, EQ102 demonstrated the prevention of intestinal tissue damage in a humanized mouse model of gastrointestinal inflammation. EQ102 is currently formulated for subcutaneous administration, where it is positioned to address an unmet need in patients experiencing symptoms despite attempts to maintain a GFD. Currently, the drug is in the Phase I stage of clinical trial evaluation for treating celiac disease.

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, Takeda.

Phases

The 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?

Key Players

• 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

Key Products

• 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

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