Celiac Disease Pipeline Advances with 25+ Therapies; Blood Test Shows Promise for Noninvasive Diagnosis
Over 25 companies are developing 30+ therapies for celiac disease, with recent positive trial results and FDA Fast Track designation. A new blood test using T-cell receptor sequencing may enable noninvasive diagnosis and monitoring.
The celiac disease treatment landscape is gaining momentum with more than 25 companies advancing over 30 pipeline therapies toward market entry, while researchers have identified a potential blood test that could eliminate the need for invasive biopsies in diagnosis and monitoring.
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. Also in May 2025, Targeted Genomics announced a commercial collaboration with OraSure Technologies for direct-to-consumer celiac genetic testing using GlutenID and ORAcollect Dx.
Companies developing celiac disease therapies include 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, and Parvus Therapeutic. Emerging therapies in the pipeline include Latiglutenase, TAK-101, TAK-227, Zamaglutenase (TAK-062), PRV-015 (Ordesekimab), KAN-101, TEV-53408, Amlitelimab, TPM-502, MTX-101, FB102, IMU-856, and ZED1227.
TEV53408 is an experimental monoclonal antibody designed for subcutaneous administration that selectively targets interleukin15 (IL15), a key cytokine driving gluteninduced immune activation and intestinal inflammation in Celiac Disease. By blocking IL15 signaling, TEV53408 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.
VTP1000 is an investigational immunotherapy built on Barinthus Biotherapeutics' SNAPTolerance Immunotherapy (SNAPTI) platform, which codelivers glutenderived peptide antigens and the immunomodulator rapamycin via selfassembled nanoparticles. Administered intramuscularly, these nanoparticles are engineered to target antigenpresenting cells and promote a switch from pathogenic effector Tcell responses to regulatory Tcell-driven immune tolerance against gluten. VTP1000 is currently in Phase I clinical development for Celiac Disease.
On the diagnostic front, researchers from Adaptive Biotechnologies, in collaboration with investigators from Mayo Clinic and other institutions, recently shared the discovery of shared T-cell receptor (TCR) signatures in the blood of people with celiac disease that strongly distinguish them from healthy controls and that are independent of gluten intake. The study uses high-throughput immune sequencing to reveal patterns in the adaptive immune system that may allow clinicians to monitor disease without invasive testing.
Researchers performed high-throughput TCR-beta sequencing on peripheral blood from over 1,600 biopsy-confirmed celiac disease patients, including individuals on long-term gluten-free diets, and compared them with more than 1,100 healthy controls. They identified hundreds of shared, disease-associated TCRs that were enriched specifically in patients with celiac disease. These signatures were detectable regardless of gluten intake, reflecting persistent memory T-cell populations that remain in circulation even when intestinal inflammation is absent.
Celiac disease is a chronic autoimmune disorder in which ingestion of gluten triggers an immune attack on the small intestine in genetically predisposed individuals. Affecting roughly one percent of the global population, its classic form is characterized by damage to the small bowel mucosa, leading to malabsorption and a range of gastrointestinal symptoms, including chronic diarrhea, abdominal pain and distension, weight loss, and, in children, poor growth. Recent screening studies in children and adolescents suggest that the prevalence of celiac disease may be much higher, reaching approximately three percent in certain populations.
Traditionally, diagnosis relies on serological testing followed by intestinal biopsy, which remains the gold standard for confirming celiac disease. However, this approach is invasive and requires patients to maintain a gluten-containing diet, a process that can be physically and emotionally burdensome. One study estimated the average wait for diagnosis at 13 years. These delays can take a significant toll on quality of life and may carry long-term health consequences, including impaired bone health and increased risk of malignancy.