Baricitinib’s Breakthrough and Why Screening for T1D Matters More Than Ever

There’s growing momentum around type 1 screening, offering hope for individuals and families with new-onset T1D. Screening finds type 1 before symptoms and severe complications like diabetes ketoacidosis (DKA). Also, identifying autoantibodies early (in stages 1 and 2) improves long-term health outcomes.

Disease-modifying treatments (DMTs) like baricitinib are effective only when beta cells are still functioning, which is why early detection is critical.

The new DMT, baricitinib, stands out as one of the most promising and the first to be administered as an oral medication.

In a landmark clinical trial, scientists found that a daily pill of baricitinib, a JAK inhibitor used initially to treat rheumatoid arthritis and other inflammatory diseases, not only preserved the body’s own insulin production but also reduced blood glucose fluctuations and lowered the need for injected insulin.

The BANDIT Study (Baricitinib in New Onset Type 1 Diabetes) 

In 2020 preclinical studies, led by Professor Tom Kay and his team at the St. Vincent’s Institute of Medical Research in Melbourne, Australia, showed that JAK inhibitors protected beta cells in mice with T1D.

Fast forward to the phase 2 trial in 2023, published in the New England Journal of Medicine, which enrolled 91 individuals aged 10 to 30 years who were newly diagnosed with T1D within 100 days of enrollment. The Breakthrough T1D-funded study had participants taking a daily pill (60 took baricitinib and 31 took a placebo) for 48 weeks.

After 48 weeks, the baricitinib group had significantly higher mixed-meal–stimulated C-peptide levels, indicating preserved insulin secretion. The group also needed less insulin and had stable glucose levels. 

Enter Eli Lilly

On October 30, 2025, Eli Lilly and Company announced two new phase 3 clinical trials for baricitinib. The BARICADE-DELAY and BARICADE-PRESERVE studies will investigate whether the drug can delay disease progression in stage 2 and stage 3 T1D patients.

Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D, said, “We’re thrilled that Lilly is advancing clinical research with baricitinib and thank them for moving us one step closer to making it available for people with type 1 diabetes.”   

Next Steps

The Eli Lilly-sponsored studies will soon be recruiting eligible participants. Details are available at Trials.Lilly.com. If successful, baricitinib could become the first widely available disease-modifying therapy for newly onset T1D patients in pill form.

Results from the Phase 3 trials (BARICADE-DELAY / BARICADE-PRESERVE) will tell us whether baricitinib’s benefits hold up in larger, more diverse populations and over longer periods. The estimated completion date for BARICADE-DELAY is July 2031, and for BARICADE-PRESERVE it is July 2028.

Safety and tolerance will need to be determined, as will infection and other immune-related risks.

Why This is a Big Deal for the T1D Community

New DMTs like baricitinib are emerging fast, and the explosion of research is creating real momentum for more funding, innovation, and breakthrough progress.

A daily pill, rather than IV infusions or injections, is also a step forward and could pave the way for other immune therapies. 

DMTs Help Future Research for Long-Standing T1D

Additionally, disease-modifying treatments like baricitinib and Tzield have major implications for people with long-standing T1D (stage 3) that people may not realize, as they are reshaping research by showing that T1D’s autoimmune attack can be slowed.

Lastly, DMTs accelerate beta-cell replacement and regeneration studies by developing biomarkers that apply to everyone. Most importantly, they bring funding and industry attention to T1D and set the framework for future combined therapies.