Novel Drug Therapeutics in Celiac Disease: A Pipeline Review.

Celiac disease (CeD) is a chronic, autoimmune systemic disorder triggered by the ingestion of gluten, a protein found in foods such as wheat, rye, and barley. The only effective treatment for CeD is complete removal of gluten from the diet. A strict gluten-free diet (GFD) results in symptomatic, serologic, and histologic remission in most patients. However, GFD may fail to induce clinical or histologic improvement and some patients may alternatively have difficulty strictly adhering to the GFD for other reasons. Despite this, there are currently no FDA-approved drugs for the treatment of CeD. The complex pathogenic process of CeD is becoming increasingly studied and better understood, enabling the identification of various targets for future therapies. Mechanisms under evaluation include probiotics, digestion of peptides, gluten sensitization, tight junction modulation, deamidation, and immune targets. Multiple investigational drugs are in the pipeline, and several drug candidates have entered late-phase clinical trials. Indeed, current and future studies are needed to target specific etiological mechanisms and provide an alternative to GFD alone. This review provides a broad overview of the various investigative treatment approaches for CeD, summarizing the latest progress in the pipeline.