Teva has reported significant progress in its pipeline of innovative drugs, with TEV '408, the company's experimental drug for treating celiac disease, meeting its primary endpoint in a Phase 2a clinical trial. Teva considers the drug an asset with significant commercial potential, having previously estimated that peak sales of the celiac treatment could reach approximately $1.5 billion to $2 billion a year.
The trial included 50 adults with celiac disease. According to Teva, the treatment successfully prevented, with statistical significance and clinical relevance, intestinal damage caused by gluten exposure compared with a placebo. The trial also recorded a positive effect on markers of intestinal inflammation and on gastrointestinal symptoms.
The company said the treatment was well tolerated, and no new safety signals have been identified so far. Celiac disease is a chronic autoimmune disease in which exposure to gluten causes the immune system to damage the small intestine. According to Teva, the disease affects approximately 1% of the global population, including more than 3 million people in the US alone.
The drug's major commercial potential also stems from the fact that there is currently no approved treatment for celiac disease. The only option available to patients is strict adherence to a gluten-free diet, but even patients who follow it closely may be unintentionally exposed to gluten and continue to suffer from symptoms and intestinal damage.
TEV '408 is an antibody developed by Teva that blocks IL-15 (a protein involved in immune system inflammation). In May 2025, the US Food and Drug Administration (FDA) granted the drug Fast Track status for treating celiac disease. The drug's potential is not limited to this disease.
Teva is also developing it to treat vitiligo and plans to advance it to a Phase 2b trial. The company defines TEV '408 as a "pipeline-in-a-product," meaning a single drug that could serve multiple indications, and has previously estimated the peak sales potential in vitiligo at approximately $1 billion more.
The importance Teva places on the drug was further reinforced by an agreement with Royalty Pharma to provide up to $500 million in funding to accelerate development. Despite the encouraging results, the road to market remains long. This is an early-stage trial that included only 50 patients, and the drug will need to undergo larger, more advanced trials. If it succeeds in those trials, TEV '408 could become one of Teva's key growth drivers in the coming years.
