For people with celiac disease, avoiding gluten is currently the only accepted treatment, but complete avoidance can be difficult in everyday life. Cross-contact, hidden ingredients and accidental exposure can still trigger damaging immune responses even in people who carefully follow a gluten-free diet.
Now, new research suggests an experimental drug may one day help offer additional protection.
In a new clinical study published in BMC Medicine, researchers found that a drug called ZED1227 helped blunt not only intestinal damage linked to gluten exposure, but also broader systemic biological changes involving metabolism, proteins and epigenetic markers in adults with celiac disease. The trial included participants who had long followed a gluten-free diet and were then exposed to small amounts of gluten for six weeks while receiving either the drug or a placebo.
The study was supported in part by pharmaceutical company Dr. Falk Pharma GmbH, which is involved in the drug’s development, alongside multiple public and academic funding sources.
Celiac disease is an autoimmune condition in which gluten triggers an immune attack that damages the small intestine. While symptoms often center on digestion, the disease can also affect other systems throughout the body.
ZED1227 works by inhibiting transglutaminase 2 (TG2), an enzyme involved in modifying gluten in ways that help trigger celiac-related immune responses.
“Our study published in 2024 showed that the drug effectively protects the intestinal mucosa,” said corresponding author Associate Professor Keijo Viiri of the University of Oulu. “We now demonstrate that its effects extend to the whole body.”
Compared with the placebo, participants taking the drug showed far fewer gluten-related disruptions in lipid metabolism and blood protein patterns. Researchers also found changes in DNA methylation markers, suggesting the treatment may help reduce broader biological stress responses linked to gluten exposure.
The findings do not mean people with celiac disease can safely return to eating gluten, nor do they suggest the gluten-free diet is becoming obsolete. This was a relatively short-term study focused on controlled gluten exposure and biomarker changes, not long-term disease outcomes or unrestricted gluten consumption.
Still, the results may represent an important step toward a future in which medication could complement dietary treatment, particularly for people who experience accidental gluten exposure or ongoing symptoms despite careful dietary management.
Much more research is needed before drugs like ZED1227 become widely available, and longer-term safety and effectiveness remain essential questions. But this study adds to growing evidence that treatment for celiac disease may eventually expand beyond strict dietary avoidance alone.
For now, experts still consider a gluten-free diet the foundation of celiac disease management. But for many patients, especially those navigating the challenges of accidental exposure, this research may offer cautious optimism that more tools could eventually be on the horizon.
This study was supported by multiple public, academic and nonprofit organizations, including the Research Council of Finland, University of Oulu, Tampere University and several Finnish foundations, as well as Dr. Falk Pharma GmbH.