Zigakibart is an investigational biologic in development for IgA nephropathy, with ongoing phase 2 and phase 3 clinical programs. Novartis trial listings state that compounds under study are investigational and not established for efficacy and safety or commercial availability. It is not yet approved.
FDA approved Novartis' Fabhalta for IgAN to slow kidney function decline. Phase III ALIGN data for Vanrafia showed ~34% slower eGFR decline vs placebo and were published in The Lancet.
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.
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 |
|---|---|---|---|
| NCT07146906 |
A Study to Assess the Effects of Zigakibart on IgA Nephropathy. |
RECRUITING | PHASE2 |
| NCT06858319 |
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. |
RECRUITING | PHASE3 |
| NCT04573478 |
Atrasentan in Patients With IgA Nephropathy |
ACTIVE_NOT_RECRUITING | PHASE3 |
