Congratulations to Celiac Disease Foundation research partner Takeda Pharmaceuticals and its Medical Director Dan Leffler on recent media attention for three potential celiac disease therapies. Takeda’s gluten-targeting therapies are featured in a recent article in Drug Discovery News (DDN); Celiac Disease Foundation is proud to partner with Takeda to recruit participants for a study that is testing TAK-062 and TAK-101, two of the three investigational medications outlined below, that were highlighted in the article:

  • TAK-062: Researchers at Takeda used a computer program to design an enzyme in the lab that specifically recognizes and targets two gluten-derived peptides. The final enzyme is among the first computationally designed proteins to proceed to clinical trials. Researchers tested TAK-062 in a clinical study that demonstrated how it effectively degrades gluten in the human body. The trial’s outcome suggests that TAK-062 can effectively detoxify small amounts of gluten (perhaps a couple hundred milligrams) that people striving for a gluten-free diet may inadvertently ingest.


  • TAK-227: The team at Takeda is also investigating an oral small molecule that inhibits tissue transglutaminase activity in the small intestine, a process that will then keep gluten in a much less inflammatory form that is less likely to trigger the body’s immune response. The researchers gave the drug to people with celiac disease along with a biscuit containing 3 grams of gluten. “This was the first trial that’s shown protection against both intestinal damage and symptoms in a gluten challenge setting, so that was really encouraging,” Dan Leffler, a gastroenterologist and medical director at Takeda, said in the DDN article.


  • TAK-101: Researchers at Takeda are also evaluating an immune tolerization therapy for celiac disease. The drug consists of gluten protein shielded within a polymer-based nanoparticle, which is injected into the bloodstream and delivered to the spleen and liver. There, “it targets the special parts of the immune system in the spleen and liver that are responsible for tolerance and telling the body not to attack,” Leffler said in the article. A recent clinical trial found that TAK-101 significantly reduced the immune response to gluten following gluten ingestion relative to the placebo.

“We are looking at different mechanisms of action for the treatment of celiac disease because nothing is approved, and we don’t know what will be potentially effective for different populations,” Leffler said in the article. “I think we will find out eventually in celiac disease that you won’t have a one-size-fits-all approach.”

TAK-062 and TAK-101 are being tested in the ILLUMINATE Studies, a program of phase 2 clinical research studies. The Celiac Disease Foundation is currently looking for interested participants; studies are now enrolling adults aged 18–75 years old with biopsy-confirmed celiac disease who have been on a gluten-free diet for at least the past 6 months.

Learn more about the ILLUMINATE Studies.

Learn about other current research studies and trials.

Read more CDF/Takeda  news:

Celiac Disease Foundation, Takeda Announce Early Career Research Award in Celiac Disease

Takeda: TAK-101 and TAK-062

Virtual Celiac Symptoms Study in Adults and Teenagers

The Virtual Celiac Symptoms Study: Symptom And Gluten-Free Diet Perceptions At Baseline (DDW poster)

Experiences of a Gluten-Free Diet in Patients with Celiac Disease: A Multi-National Survey

Disease Burden and Quality of Life Impacts In Patients With Celiac Disease On A Gluten-Free Diet (DDW poster)