FDA granted traditional approval to Novartis' Fabhalta (iptacopan) for IgA nephropathy. Phase 3 APPLAUSE-IgAN data showed eGFR decline slowed by 48% versus placebo over two years.
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.
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.
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 |
|---|---|---|---|
| NCT07498335 |
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN |
RECRUITING | PHASE3 |
| NCT07024563 |
Study of Ravulizumab in Pediatric Participants With Primary IgAN |
RECRUITING | PHASE3 |
| NCT06797518 |
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN |
RECRUITING | PHASE2 |
| NCT06291376 |
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05834738 |
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy |
COMPLETED | PHASE2 |
| NCT05248646 |
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04663204 |
A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy |
RECRUITING | PHASE2 |
| NCT04573920 |
Atrasentan in Patients With Proteinuric Glomerular Diseases |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04573478 |
Atrasentan in Patients With IgA Nephropathy |
ACTIVE_NOT_RECRUITING | PHASE3 |
