Ianalumab is a fully human monoclonal antibody in late-stage development for Sjögren’s disease. Its dual mechanism combines B-cell depletion with inhibition of B-cell activation and survival via BAFF-R blockade. Novartis announced FDA Breakthrough Therapy designation in January 2026 and planned global regulatory submissions starting in early 2026.
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.
Three comprehensive reports examine the monoclonal antibody landscape, covering CD47-targeted immunotherapy pipelines, competitive analysis of 180+ companies developing mAb therapeutics, and recombinant antibody market forecasts through 2033.
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07421167 |
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) |
RECRUITING | PHASE2 |
| NCT07244289 |
Managed Access Programs for VAY736, Ianalumab |
AVAILABLE | |
| NCT07039422 |
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab |
RECRUITING | PHASE2 |
| NCT06711887 |
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension) |
RECRUITING | PHASE3 |
| NCT06470048 |
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis |
RECRUITING | PHASE2 |
| NCT06411639 |
Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases |
WITHDRAWN | PHASE1 |
| NCT06133972 |
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). |
RECRUITING | PHASE3 |
| NCT05885555 |
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05653349 |
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05653219 |
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids |
ACTIVE_NOT_RECRUITING | PHASE3 |
