IgAN is the common abbreviation for IgA nephropathy, a primary glomerular disease caused by immune-complex deposition of IgA in the kidney mesangium. It often presents with hematuria and variable proteinuria, with long-term risk of chronic kidney disease progression in a subset of patients. Disease course is heterogeneous and requires longitudinal nephrology follow-up.
Vertex's Phase 3 RAINIER trial of povetacicept in IgA nephropathy met its primary endpoint with a 52% UPCR reduction. The FDA granted rolling review, and Vertex plans full BLA submission by end of March. Shares rose on the news and analyst upgrades.
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
Novartis commits $23 billion to U.S. manufacturing expansion with new facilities in North Carolina, California, and Florida, while advancing its immunoglobulin A nephropathy drug portfolio with positive Phase III results for Vanrafia.
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.
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07606352 |
Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07502638 |
FXS6837 for the Treatment of IgAN Patients |
NOT_YET_RECRUITING | PHASE2 |
| NCT07474636 |
Efficacy and Safety Study of HS-10542 for IgA Nephropathy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07024563 |
Study of Ravulizumab in Pediatric Participants With Primary IgAN |
RECRUITING | PHASE3 |
| NCT06989359 |
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease |
RECRUITING | PHASE2 |
| NCT06983028 |
Atacicept in Multiple Glomerular Diseases |
RECRUITING | PHASE2 |
| NCT06291376 |
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) |
RECRUITING | PHASE3 |
| NCT05125068 |
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN) |
TERMINATED | PHASE2 |
| NCT05097989 |
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) |
TERMINATED | PHASE2 |
| NCT04287985 |
Safety and Efficacy Study of VIS649 for IgA Nephropathy |
COMPLETED | PHASE2 |
