Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results

Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations.

TAK-101 is a nanoparticle that carries gliadin, a gluten protein, intended to retrain the immune system to ignore gluten. Takeda licensed the asset from Cour Pharmaceuticals in 2019 in a deal valued at $420 million.

The phase 2 trial enrolled about 101 patients and evaluated whether the drug could lower gluten-related symptoms and immune activation. The study completed in January, and Takeda’s earnings release indicated the results were not compelling enough to continue.

With this program dropped, Takeda’s celiac pipeline is now reduced to a single candidate, limiting its near-term prospects in the disorder where the only approved therapy remains a gluten-free diet.