What is the new medication for Sjogren's? Investigational Therapies Showing Promise

October 9, 2025 •

3 min read

For decades, patients with Sjögren's have lacked targeted treatments for the underlying causes of their disease. Exciting breakthroughs are now emerging from clinical trials, which is why many are asking: What is the new medication for Sjogren's? Research and development have introduced several promising new candidates, including nipocalimab and ianalumab.

Quick Summary

Investigational therapies, such as nipocalimab and ianalumab, are advancing through clinical trials for Sjögren's disease. These targeted medications address specific immune system pathways, offering a major shift from previous symptom-focused treatments.

Key Points

Nipocalimab: An investigational monoclonal antibody from Johnson & Johnson with FDA Breakthrough Therapy and Fast Track designations.
Ianalumab: A B-cell targeted therapy by Novartis that met primary endpoints in Phase 3 trials in August 2025.
Targeted Mechanisms: Both drugs aim to modify the disease by targeting specific immune pathways.
Clinical Trial Success: Improved trial designs contribute to better evaluation of treatment effectiveness.
Symptom-Specific Treatments: An experimental cell therapy for dry mouth is also in clinical trial.
Regulatory Momentum: Expedited FDA reviews highlight the need for new treatment options.

A New Era of Targeted Therapy for Sjögren's

Sjögren's disease is a chronic autoimmune condition primarily affecting moisture-producing glands, but it can also cause widespread systemic symptoms. The current standard of care largely focuses on managing symptoms with over-the-counter and prescription products like artificial tears and saliva substitutes, as well as general immunosuppressants in some cases. This has left a significant unmet need for treatments that address the root cause of the autoimmune response. Recent advancements, however, are shifting the paradigm towards more specific, targeted therapies.

Nipocalimab: Blocking IgG Autoantibodies

Nipocalimab, an investigational monoclonal antibody from Johnson & Johnson, works by blocking the neonatal Fc receptor (FcRn). This action reduces the levels of disease-causing IgG autoantibodies that contribute to inflammation in Sjögren's.

Regulatory Milestones: The U.S. FDA granted nipocalimab Breakthrough Therapy designation for moderate-to-severe Sjögren's in November 2024, followed by Fast Track designation in March 2025.
Clinical Efficacy: Results from the Phase 2 DAHLIAS trial showed significant improvement in systemic disease activity and patient-reported symptoms. A Phase 3 study is ongoing.

Ianalumab: A Dual-Action B-Cell Therapy

Ianalumab (VAY736) from Novartis is another promising investigational fully human monoclonal antibody. It targets B-cells, which are involved in Sjögren's, through a dual mechanism that combines B-cell depletion and inhibition of BAFF-R signaling.

Positive Phase 3 Results: In August 2025, Novartis announced positive top-line results from its two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2. Both trials met their primary endpoint by demonstrating statistically significant improvements in disease activity. This is noted as the first time a global Phase 3 trial in Sjögren's has achieved such a significant reduction in disease activity.
Next Steps: Novartis plans to submit the data from these successful trials to regulatory authorities globally.

Experimental Cell Therapy for Dry Mouth

Beyond systemic treatments, research is also exploring ways to address specific symptoms. In February 2025, a clinical trial began at the University of Wisconsin for an experimental cell therapy targeting severe dry mouth (xerostomia) by aiming to repair damaged salivary glands.

A Comparison of Leading Investigational Therapies

To provide a clearer picture of the primary new drug candidates, here is a comparison of nipocalimab and ianalumab.


Feature	Nipocalimab	Ianalumab (VAY736)
Manufacturer	Johnson & Johnson	Novartis
Mechanism of Action	Blocks FcRn to reduce circulating IgG autoantibodies.	Dual action: B-cell depletion (via ADCC) and BAFF-R inhibition.
Clinical Trial Stage	Phase 3 underway.	Phase 3 completed with positive results (Aug 2025).
FDA Designations	Breakthrough Therapy (Nov 2024), Fast Track (Mar 2025).	Fast Track (granted prior to Aug 2025).
Targeted Problem	Reduction of systemic disease activity driven by IgG autoantibodies.	Reduction of disease activity driven by B-cells.
Administration	Intravenous infusion.	Not specified, but Phase 3 tested monthly and quarterly dosing.

The Impact of New Research and Patient Advocacy

The progress in developing new therapies is partly due to improved clinical trial design, which now often includes stricter criteria focusing on patients with higher disease activity and autoantibody positivity to better evaluate treatment effects. The Sjögren's Foundation also plays a key role in supporting research and raising awareness for the patient community.

Conclusion: Hope for the Future

The emergence of targeted therapies like nipocalimab and ianalumab represents a significant advancement in the potential treatment of Sjögren's disease. These investigational drugs offer the possibility of addressing the underlying causes of the disease rather than just managing symptoms, providing a hopeful outlook for patients. While regulatory approval is still needed, the positive clinical trial results and expedited designations underscore the potential for a new era of Sjögren's treatment.

Learn more about the latest research and developments by visiting the Sjögren's Foundation website: https://sjogrens.org/.

Frequently Asked Questions

As of September 2025, there are no newly FDA-approved advanced therapies for the systemic treatment of Sjögren's disease. However, several investigational drugs, such as nipocalimab and ianalumab, are showing promising results in late-stage clinical trials.

Nipocalimab is an investigational monoclonal antibody that aims to reduce inflammation in Sjögren's by blocking the FcRn receptor and lowering levels of disease-causing IgG autoantibodies. It received FDA Breakthrough Therapy designation in late 2024.

Ianalumab is an investigational B-cell targeted therapy from Novartis that works by depleting B-cells and inhibiting BAFF-R signaling. It recently met its primary endpoint in Phase 3 trials, showing significant improvement in disease activity.

These new drugs are targeted therapies that address specific immune pathways involved in Sjögren's, whereas older treatments often focus on symptom management or use broader immunosuppression. This targeted approach has the potential for more specific disease modification.

An experimental cell therapy for severe dry mouth in Sjögren's patients is in a clinical trial that began in February 2025 at the University of Wisconsin. This therapy is designed to target the damaged salivary glands.

Nipocalimab is currently in a Phase 3 study. For ianalumab, following positive Phase 3 results, the manufacturer plans to submit data to regulatory agencies globally for review.

These medications are investigational and not available for general prescription. Patients may be able to participate in clinical trials for these or other pipeline drugs by discussing options with their rheumatologist or checking clinical trial registries.

Both nipocalimab and ianalumab have demonstrated positive results in late-stage clinical trials. Nipocalimab has received significant FDA designations, and ianalumab reported successful Phase 3 outcomes. Both represent significant progress in the field.