Also known as: Sjögren disease
Alumis reported that 54% of psoriasis patients achieved complete skin clearance (PASI 100) at 48 weeks in the ONWARD3 study, with 75% achieving PASI 90. The company plans to submit an NDA for envudeucitinib in Q4 2026.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
A study suggests a 16-protein blood test, the Sjögren’s protein score, may measure salivary gland inflammation without biopsy. The score correlated with glandular inflammation, antibodies, and extraglandular disease features.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07737743 |
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease |
NOT_YET_RECRUITING | PHASE2 |
| NCT07649265 |
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body |
NOT_YET_RECRUITING | PHASE1 |
| NCT07284797 |
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases |
RECRUITING | PHASE1 |
