Celiac disease is a chronic autoimmune condition in which eating gluten — a protein found in some cereals like wheat, barley and rye — triggers the immune system to attack the small intestine. This can lead to symptoms such as abdominal pain, diarrhea, fatigue, nutrient deficiencies and long-term complications, if untreated. The only currently approved treatment is a lifelong, strict gluten-free diet, which requires complete avoidance of gluten-containing foods as well as hidden traces caused by cross-contamination during food production, processing, or preparation at home. This treatment works for many people, but it can be burdensome, costly, and difficult to maintain, and some patients still experience symptoms regardless of careful adherence.
Despite decades of research and a clearer understanding of celiac disease biology, there are no pharmaceutical drugs approved yet that can replace or reliably supplement the gluten-free diet. On this line, different strategies have been researched up to date with the aim of offering a pharmaceutical solution to celiac disease (1).
Researchers have explored many potential approaches, but so far none have fully succeeded in clinical trials. For example, scientists have investigated enzymes designed to break down gluten in the stomach before it triggers an immune response, the so-called glutenases. While early laboratory and some small clinical studies showed promise, the results have been inconsistent and not robust enough to support regulatory approval.
Other strategies under investigation include drugs that attempt to modulate the immune response, reduce intestinal permeability or neutralize gluten proteins before they can cause harm. Immune modulators aim to interfere with key steps in the inflammatory cascade triggered by gluten and permeability modulators target the “leaky gut” seen in celiac disease. However, many of these approaches have shown limited efficacy or mixed results in human studies.
There is also growing interest in therapies based on the gut microbiome, probiotics and nutraceuticals that might help support gut health. While these are intriguing areas of research, they are largely experimental and, again, have not yet demonstrated clear clinical benefits in the appropriate regulatory framework that could lead to new treatments.
Why has progress been so slow? Celiac disease is complex and multifactorial, involving immune system dysfunction, genetic predisposition and interactions with the gut environment. This complexity makes it hard to find a single drug that can safely and effectively address the disease’s root causes.
In summary, although scientific advances have expanded our understanding of celiac disease and many potential drugs are in development, the only effective therapy is still a gluten-free diet. For people living with celiac disease, this means maintaining a strict gluten-free diet that affects everyday food choices and social life, while for researchers it means that the search for safe and effective treatments must continue.
References
1Girbal-González, M., & Pérez-Cano, F. J. (2025). Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments. Nutrients, 17(18), 2960.

