Astellas ends ASP5502 Sjögren’s trial as Novartis’ ianalumab gains FDA breakthrough tag
Astellas terminated its phase 1 ASP5502 study in Sjögren’s syndrome as Novartis said the FDA granted breakthrough therapy designation to ianalumab. Novartis plans global regulatory submissions from early 2026 after positive phase III data.
Astellas Pharma has terminated a phase 1 study of ASP5502 for Sjögren’s syndrome, while Novartis said the US Food and Drug Administration granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease. The cancellation of ASP5502 “was a business decision and not related to safety or efficacy observed in the study,” while ianalumab’s designation was supported by positive data from multiple studies, including replicate phase III trials.
Astellas said the study, which enrolled 116 people, will complete its current cohort, while the future of ASP5502 “will be disclosed at the appropriate time.” The trial was designed in three parts: a single oral dose of the ASP5502 tablet in healthy volunteers, daily treatment for two weeks in healthy volunteers, and daily doses of the molecule for four weeks in patients with Sjögren’s syndrome.
Novartis said it plans to submit ianalumab for regulatory approval globally starting in early 2026. The company said ianalumab is a fully human monoclonal antibody with a dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade. If approved, ianalumab would become the first targeted treatment for patients with Sjögren’s disease.
In the phase III NEPTUNUS-1 and NEPTUNUS-2 trials, Novartis said ianalumab delivered a clinically meaningful benefit, showing improvement in disease activity and reductions in patient burden. The company said ianalumab demonstrated a favorable safety profile with an overall incidence of adverse events and serious adverse events comparable to placebo in both studies.
Sjögren’s syndrome is an autoimmune disease in which the patient’s immune system attacks the tear and salivary glands, leading to dry eyes and mouth. Those primary symptoms can also be accompanied by issues affecting the joints, nerves, lungs and other organs. There are no approved targeted treatments available for Sjögren’s disease, and the FDA has never approved a drug specifically designed to treat Sjögren’s.
Astellas’ trial termination follows other companies that have ditched assets in the indication. At the beginning of 2025, Novartis gave up on anti-CD40 antibody iscalimab, while continuing to pursue ianalumab for Sjögren’s and other autoimmune diseases. ASP5502 is a small-molecule inhibitor of STING, a pathway that plays a key role in promoting inflammation, and one of the few molecules in the clinic targeting the pathway.