Novartis candidate for Sjögren’s disease presents positive results
Ella Day | August 15, 2025 | News story | Research and Development | Immunology, Novartis, Sjögren’s disease, US Food and Drug Administration, clinical trial
Novartis has reported positive results from two phase 3 clinical trials – NEPTUNUS-1 and NEPTUNUS-2 – evaluating ianalumab in adults with active Sjögren’s disease. Both trials met their primary endpoint, showing statistically significant improvements in systemic disease activity compared with placebo, measured by the EULAR Sjögren’s syndrome disease activity index.
Sjögren’s disease is a chronic autoimmune disorder affecting around 0.25% of the population, primarily women. It is associated with dryness, fatigue, pain and – in some cases – organ involvement. No targeted systemic treatments are currently approved.
Ianalumab is a monoclonal antibody with a dual mechanism of action: depleting B cells through and inhibiting receptor protein, BAFF-R, signalling. The drug was well tolerated in the trials and showed a favourable safety profile.
“Sjögren’s disease is a serious, progressive condition with very limited treatment options,” said Shreeram Aradhye, president of development and chief medical officer at Novartis. “These studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings.”
NEPTUNUS-1 enrolled 275 patients to receive ianalumab 300 mg subcutaneously once a month or placebo for 52 weeks. NEPTUNUS-2 enrolled 504 patients, randomised to ianalumab monthly, every three months, or placebo, also for up to 52 weeks.
Novartis intends to submit regulatory applications globally. Ianalumab already has Fast Track designation from the US Food and Drug Administration for Sjögren’s disease.
Ella Day
15/8/25
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