Novartis Ianalumab First Drug to Reduce Disease Activity and Patient Burden in Sjögren's Disease Phase III Trials
Sjögren's disease is one of the most common rheumatic autoimmune conditions in the world, affecting millions of people, most of them women. It causes the immune system to attack moisture-producing glands throughout the body, resulting in debilitating dryness of the eyes and mouth, deep fatigue, widespread pain, and a significantly elevated risk of developing lymphoma over time. For decades, people living with Sjögren's have had no targeted therapies to slow or control the underlying disease. That appears to be changing.
In October 2025, Novartis announced results from two landmark Phase III clinical trials, NEPTUNUS-1 and NEPTUNUS-2, evaluating a drug called ianalumab in people with active Sjögren's disease. The results were presented at the American College of Rheumatology Convergence, one of the leading scientific meetings in rheumatology. These are the first Phase III trials in Sjögren's disease history in which a treatment achieved statistically significant improvement in overall disease activity.
Ianalumab works through a dual mechanism. It depletes B cells, the immune cells most responsible for driving Sjögren's-related inflammation, and it blocks a signaling protein called BAFF-R, which B cells need for their activation and survival. By targeting both mechanisms simultaneously, ianalumab aims to interrupt the root cause of disease rather than simply managing individual symptoms.
Patients receiving ianalumab 300 mg monthly showed meaningful reductions in disease activity as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), the primary endpoint in both trials. Improvement was detectable as early as Week 16 and was sustained throughout the full 52 weeks of the study. Patients also reported improvements in dryness, pain, and fatigue using validated patient-reported outcome tools, and stimulated salivary flow, one of the most direct markers of gland function, improved compared to placebo.
The NEPTUNUS trials enrolled participants at 219 sites across 35 countries, making them among the most globally representative Sjögren's trials ever conducted. The safety profile of ianalumab was described as favorable. Professor Xavier Mariette, who led the research at Bicêtre Hospital in Paris, called the results the first demonstration that a treatment can significantly improve disease activity in Sjögren's and potentially provide clinically meaningful benefit to patients. Novartis plans to submit ianalumab for regulatory approval worldwide starting in early 2026. If approved, it would become the first targeted treatment specifically designed for Sjögren's disease, a milestone patients and advocates have waited a very long time for.