Cell Therapy for Sjögren's Disease Dry Mouth Earns FDA Fast Track Designation
Sjögren's disease is a chronic autoimmune condition that attacks moisture-producing glands, leading to its two most disruptive symptoms: persistent dry eyes and dry mouth. The mouth dryness, known medically as xerostomia, can make eating, speaking, and swallowing genuinely difficult, and it significantly affects daily quality of life for the estimated four million Americans living with the condition. Despite how burdensome xerostomia can be, effective targeted treatments have been hard to come by — until now, most people are left managing symptoms rather than addressing the underlying problem.
A new development offers real hope. Researchers at the University of Wisconsin School of Medicine and Public Health are testing an experimental cell therapy in a Phase 0 clinical trial specifically designed to treat dry mouth caused by Sjögren's disease. In February 2026, the therapy received Fast Track designation from the U.S. Food and Drug Administration, a recognition that the FDA views this as a serious unmet medical need and wants to support its development. According to the research team, this is currently the only therapy of its kind in the United States targeting xerostomia from Sjögren's disease.
The treatment was developed by the UW Program for Advanced Cell Therapy, a collaboration between UW Health and the University of Wisconsin School of Medicine and Public Health. Cell therapies work by introducing living cells to restore or replace damaged tissues or functions. In this case, researchers hope the approach can help restore the function of salivary glands that have been damaged by the autoimmune process — going beyond symptom management to address the root source of the problem.
Fast Track designation doesn't mean the therapy is approved for use, but it does mean the FDA has agreed to work more closely with the development team throughout the review process. It can meaningfully shorten the approval timeline, which for new drugs and medical devices can otherwise stretch to ten years or more. The designation is selectively granted to investigational treatments addressing serious conditions where existing options fall short, so receiving it is a strong signal that regulators see genuine promise here.
The Phase 0 trial is an early exploratory stage, focused on initial data about how the therapy behaves in the human body before moving on to Phase 1 and Phase 2 trials that assess safety and efficacy more fully. Researchers are cautiously optimistic that the results will support further clinical development. For people with Sjögren's disease who have spent years managing unrelenting dry mouth with limited options, this is the kind of research progress that matters most. Alongside other recent advances — including ianalumab and nipocalimab, which have each received Breakthrough Therapy designations for broader systemic disease activity — this cell therapy signals that the treatment landscape for Sjögren's disease is changing in meaningful ways.